Cognitive DeclineNCT04068376

Double-task Exercise in Older Adults at Risk of Cognitive Decline (MeMo-Health-Cog-3 Program)

A study testing "Mind and Movement for Cognitive Health in the Older Adult" and Double-task exercise by older adults and their caregivers in people with Cognitive Decline and Vascular Health, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 60 to 65 years
Conditions the study is for: Cognitive Decline, Vascular Health
What is being tested?: "Mind and Movement for Cognitive Health in the Older Adult" and Double-task exercise by older adults and their caregivers
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteMexico
Study dates: 1 May 2023to 1 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

With 60-75 years of age.
They have self-reported cognitive concerns (ie, have answered "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?").
They demonstrate functional independence in activities of daily living and instrumental activities of daily living.
They have one or more vascular risk factors (eg, type 2 diabetes or hypertension).
They have symptoms or signs of underlying cognitive dysfunction without a diagnosis of dementia (ie, confirmed by a review of their health records and a Mini Mental State Exam [MMSE] score> 24).
They have an informal caregiver who accepts to participate.

Who cannot join

With depression (score> 15 according to the Center for Epidemiological Studies Depression Scale - Revised [CESD-R]).
With clinically significant neurological or psychiatric disorders (eg, Parkinson's, schizophrenia).
With a recent severe cardiovascular event (eg, myocardial infarction, stroke).
With a major orthopedic condition (eg, severe osteoarthritis).
With blood pressure that is unsafe for exercise (ie,> 180/100 mmHg or <100/60 mmHg).
With a severe visual or auditory impairment.
With an unwillingness to adhere to the intervention schedules.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Rosalinda Sánchez Arenas
Mexico City, 06720

Other trials in Mexico

About this study

Official title: Double-task Exercise Programs to Strengthen Cognitive and Vascular Health in Older Adults at Risk of Cognitive Decline: a Randomized Clinical Trial

Cerebral small vessel disease is a frequent cause of cognitive disability among older adults (OAs) in Mexico that imposes a significant burden on the health system and OAs' families. We have called the program Mind and Movement for Cognitive Health (MeMo-Salud-Cog-3). Programs to prevent or delay OAs' cognitive decline are scarce. Methods and analysis: A double-blind, randomized clinical trial will be conducted. The study will aim to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for OAs at risk of cognitive decline-one program with and another without caregiver participation-and to compare these with an aerobic-balance-stretching exercise program (control group). 255 OAs (85 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 65 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups. The intervention will last 24 weeks, and the effect of each program will be evaluated 12, 24, and 52 weeks after the intervention. Participants' demographic and clinical characteristics will be collected at baseline. The outcomes will include: (i) general cognitive function; (ii) specific cognitive functions; (iii) dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) OAs' health-related quality of life; and (viii) caregiver burden. We will estimate differences in outcomes between each intervention group and the control group at baseline and follow-up evaluations. We will assess differences-in-differences (D-in-D) treatment effects using a D-in-D estimator. If we identify statistically significant differences in participants' baseline characteristics between the groups, we will adjust the D-in-D estimators by these covariates using generalized linear regression models. Ethics and dissemination: The study was approved by the IMSS Ethics and Research Committee (registration number 2018-785-095). All participants will sign a consent form prior to their participation. The study results will be disseminated to IMSS authorities, healthcare providers and the research community.

Read the detailed description

Aim: to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for older adults (OAs) at risk of cognitive decline - one program with and another without caregiver participation - and to compare these with an aerobic-balance-stretching exercise program (control group). 255 OAs (85 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 75 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups.
Study design: A double-blind randomized clinical trial entitled "Mind and Movement: Towards the Cognitive Health of Older Adults" will be conducted. The study will include two intervention groups and one control group: (1) a double-task exercise program with a squared mat led by a coach (a health professional) for 24 weeks (T1-GR); (2) the same exercise program led by a coach (a health professional) for 12 weeks and then led by caregivers of older adults for another 12 weeks (T2-GR); and (3) a control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).
Study hypothesis: The investigators hypothesize that T1 and T2 double-task exercise trainings will show more significant improvements in older adults than the control aerobic training with regards to (i) general cognitive function; (ii) specific cognitive functions (executive function, processing speed, verbal learning and memory, and verbal fluency); (iii) usual walking and dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) older adults' health-related quality of life; and (viii) caregiver burden.
Sample Size: It was calculated using the formula suggested by Zong (2009)32 for continuous outcome variable and non-inferiority design (2 [Z 1-α+Z 1-β/ δ] * S2). The investigators considered α <0.05, a power of 80%, and the assumptions to δ0 (a clinically acceptable margin) and S2(polled standard deviations of both comparison groups): General cognitive function=0.20(0.05), Mental flexibility (EF) part A=0.13(0.03) and B=0.37(0.37), Processing speed=0.06(0.02), Verbal learning=0.63(0.32) and memory=0.16(0.08), Verbal fluency words by category= 0.54 (0.14) and by letter=0.66 (0.17), Walking speed (cm/s)=0.23(0.06), Walking length(cm)=0.86(0.22), Systolic blood pressure(mmHg)=0.27(0.06); Diastolic blood pressure(mmHg)=0.79(0.40), Carotid intima-media thickness(mm)=0.20(0.05).Subjective burden on informal caregivers=0.53, Patient health-related quality of life (SF-36) Mental score=4.0(1.0) and Physical score=4.0(2.0). The maximum required sample size, assuming a possible 20% drop-out rate, is 85 participants per group.
Intervention implementation: The study will be conducted at IMSS Epidemiology and Health Services Research Unit facilities in Mexico City. The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health professional with a nursing background previously certified to coach SSE trainings by the Institute of Square-Stepping Exercise in Mie, Japan (Chief Tomohiro Okura and Overseas Director Professor Ryosuke Shigematsu). In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.
Compliance and adverse events monitoring A monitoring system will be developed to perform long-distance monitoring of compliance with physical activity. It will include three components: i) the system that will collect the information from a chipset connected to the SSE mats (e.g., time of exercise, velocity); ii) the system that will transmit and store the data on the study computer; iii) the system for supervision and follow-up, which will allow connecting with participants through different electronic devices, such as mobile phones and e-mails. The monitoring system will be an important strategy to avoid missing data, drop-out rates and low program adherence. In addition, the investigators will monitor study adverse events through direct observations of the study participants during the exercise sessions, monitoring system, and 12-, 24-, and 54-week evaluations. The investigators will register number, type (e.g., dizziness, pain, fatigue, muscle strains, falls, or injuries), and severity of adverse events during the exercise sessions and outside the hours of the exercise sessions but during the intervention period. The severity of events will be categorized as follows: mild (do not affect activities of daily living); moderate (have moderate effect on activities of daily living); and severe (requires hospitalization, or results in persistent or significant disability or results in some life-threatening, or other medically important condition). RSA and ABD will review all adverse events on a weekly basis. They will report all moderate and severe adverse events to the IMSS Ethics Committee and stop the study if the adverse events data demonstrate any hazard of the intervention.
Motivation strategies The monitoring system will be an important strategy to avoid drop-outs and low program adherence. It will be complemented by motivation phone calls to those participants who fail to attend the group sessions or to perform home-based SES activities. Moreover, the study will include 10-15 minute group discussions to explore health-related topics, such as the benefits of healthy lifestyles (e.g., physical activity, nutrition) to maintaining cardiovascular and brain health or to exchange experiences on past events. The discussions will precede exercise training sessions.
Evaluations The investigators will conduct four evaluations during the study: the baseline evaluation and 12-week, 24-week, and 52-week evaluations. The study outcome variables will be measured at each evaluation, while the covariates will be collected only at the beginning of the study. The investigators will also measure the participants' adherence to the programs, defined as 80% or higher compliance with the assigned exercise training regimen. Finally, the investigators will document the reasons for dropouts and poor adherence. Previously trained health professionals with a medical specialty in geriatrics will perform these evaluations. The study covariates will cover Participant demographic and clinical characteristics: age (years from birth); biological sex (male or female); formal educational attainment (years); current employment status (retired, employed, volunteer, unpaid worker, unemployed); marital status (married, widowed, divorced, single, other); and current living situation (living alone, living with a spouse, living with or without children); self-reported comorbidities relevant to this study (e.g., vascular risk factors, orthopedic conditions, etc.); and self-reported baseline physical activity defined as i) ideal (≥150 minutes per week of moderate-intensity activity or ≥75 minutes per week of vigorous-intensity activity, or an equivalent combination); ii) moderate/intermediate (≤149 minutes per week of moderate-intensity activity or ≤74 minutes per week of vigorous or intense activity, or an equivalent combination); and iii) poor (without any moderate or intense physical activity). The apolipoprotein E (APOE) ε4 allele is a genetic risk factor for Alzheimer's. Caregivers will be asked the following: age, biological sex, formal educational attainment, current employment status, marital status, relation to the patient, and self-reported baseline physical activity, as previously defined; availability of social support networks; and presence of animal companions at home. Social support will be measured using the Household and Family Support Networks subsection (part 5) of the World Health Organization Study on Global AGEing and Adult Health.
Data Management and confidentiality Data entry will be conducted by trained staff. Data quality will be assessed before statistical analysis (eg, range checks for data values). Only members of the study team will have access to the study information and all information that will be collected from participants will be kept private to ensure confidentiality. The consent forms with participant signatures will be stored in a locked location only accessible by the principal investigator (PI). All electronic data will be stored on the PI laptop and a back-up hard drive which will be password protected. Any handwritten information such as field notes or other related research materials will be stored and secured in a locked cabinet when not in use. Data will be erased and destroyed after 5 years, as per IMSS Ethics and Research Committee guidelines. Only deidentified data will be used for reporting, publication, and dissemination of findings.
Statistical Analysis First, the investigators will perform a descriptive analysis of the older adults' and caregivers' characteristics at each evaluation and evaluate the distribution of quantitative variables using the Kilmogorov-Smirnov normality test. Variables that have normal distribution will be analyzed using means and standard deviations, variables with non-normal distribution will be presented using medians and 25th and 75th percentiles, and categorical variables will be analyzed by using frequencies and percentages. Second, for each evaluation the investigators will compare study variables between T1-GR and C-GR and between T2-GR and C-GR. The comparison between these groups will be performed using Student's t-test (for normally distributed continuous variables), Mann Whitney-U test (for continuous variables that are not normally distributed), or Chi-square test (for categorical variables), as appropriate. The difference between baseline and post-intervention evaluations for each group will be measured using the Student's paired t-test or Mann-Whitney U test when the distribution is non-normal. The effect of the intervention on the outcome variables will be assessed by estimating the differences-in-differences (D-in-D) treatment effects using a D-in-D estimator.46 If the investigators identify statistically significant differences in participants' baseline characteristics and adherence to the exercise regimens among the studied groups, the model will adjust the results of the D-in-D treatment effects by these covariates using a generalized linear regression model (GLM), where Yi= ß0+ ß1Xi+ß2X+ ß3X +ßjCov +ei; in this regression equation, ß1 represents the mean difference within each group, β2 the mean change after the intervention, β3 the difference in mean change between the two groups (e.g., T1-GR and C-GR), ßjCov the covariates that were different between the study groups, and ei= the standard error. This model considers the correlation among repeated observations of the same subject and allows a more precise estimate to be obtained. The investigators will conduct a model for each outcome variables. P-values < 0.05 will be interpreted as statistically significant. The analyses will be performed using the software Stata 14.0 (Stata Corp, College Station, TX, USA).

Conditions: Cognitive Decline, Vascular Health
Being tested: Control excercise, "Mind and Movement for Cognitive Health in the Older Adult", Double-task exercise by older adults and their caregivers
Keywords: cognitive decline, double task, older adults
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control excerciseOther
Also called Aerobic-balance-stretching exercise program
Each session will be for 60 minutes, 3 days a week, for 24 weeks. The make-up of each session is 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of balance-stretching exercise; and 5) 5 minutes of cool-down stretching (this times does not count as activity).
"Mind and Movement for Cognitive Health in the Older Adult"Other
Also called Double-task exercise by a health professional
The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health profesional certified to coach SSE. The make-up of each session is: 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of double-task exercise (mat); and 5) 5 minutes of cool-down stretching (this times does not count as activity).
Double-task exercise by older adults and their caregiversOther
In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.

Study groups in NCT04068376
Study group	Role	What they receive
Control group (C-GR)	Active comparator	Control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR). Receives: Other: "Mind and Movement for Cognitive Health in the Older Adult"; Other: Double-task exercise by older adults and their caregivers
T1-GR training sessions by health professional	Experimental	The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health professional with a nursing background previously certified to coach SSE trainings by the Institute of Square-Stepping Exercise in Mie, Japan (Chief Tomohiro Okura and Overseas Director Professor Ryosuke Shigematsu). Receives: Other: Control excercise
T2-GR older adults and their caregivers	Experimental	In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults. Receives: Other: Control excercise

What is being measured

The primary outcome is the main question the study is designed to answer.

General Cognitive funtion
1. Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehens cognitive assessment, with total scores ranging from 0 to 69.
Measured: 0 weeks
General Cognitive funtion
1. Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehensive cognitive assessment, with total scores ranging from 0 to 69.
Measured: 24 weeks
General Cognitive funtion
1. Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehens cognitive assessment, with total scores ranging from 0 to 69.
Measured: 52 weeks
Specific domains of cognitive function
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter. The frontal assessment battery (FAB)
Measured: 0 weeks
Specific domains of cognitive function
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
Measured: 24 weeks
Specific domains of cognitive function
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
Measured: 52 weeks
Cognitive reserve
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Measured: 0 weeks
Cognitive reserve
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Measured: 24 weeks
Cognitive reserve
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Measured: 52 weeks

Secondary outcomes (18)

Usual walking and dual-task gait
Usual walking and dual-task gait will be evaluated through motion capture during the six-minute walk test (6MWT), which requires participants to walk back and forth across a 30-metre area at a comfortable pace for six minutes. The fixed distance utilized by 6MWT allows determination of gait speed (i.e., v=d/t); however, this test will also be coupled with infrared stride analysis, which will allow for a more precise evaluation of gait speed, stride length, and stride variability under usual and dual-task conditions. These procedures will provide a number of valid and reliable gait outcomes through the synchronization of mobility data via eight infrared cameras, six force plates, and electromyography.
Measured: 0 weeks
Usual walking and dual-task gait
Usual walking and dual-task gait will be evaluated through motion capture during the six-minute walk test (6MWT), which requires participants to walk back and forth across a 30-metre area at a comfortable pace for six minutes. The fixed distance utilized by 6MWT allows determination of gait speed (i.e., v=d/t); however, this test will also be coupled with infrared stride analysis, which will allow for a more precise evaluation of gait speed, stride length, and stride variability under usual and dual-task conditions. These procedures will provide a number of valid and reliable gait outcomes through the synchronization of mobility data via eight infrared cameras, six force plates, and electromyography.
Measured: 24 weeks
Usual walking and dual-task gait
Usual walking and dual-task gait will be evaluated through motion capture during the six-minute walk test (6MWT), which requires participants to walk back and forth across a 30-metre area at a comfortable pace for six minutes. The fixed distance utilized by 6MWT allows determination of gait speed (i.e., v=d/t); however, this test will also be coupled with infrared stride analysis, which will allow for a more precise evaluation of gait speed, stride length, and stride variability under usual and dual-task conditions. These procedures will provide a number of valid and reliable gait outcomes through the synchronization of mobility data via eight infrared cameras, six force plates, and electromyography.
Measured: 52 weeks
Carotid intima-media thickness (cIMT)
Carotid intima-media thickness (cIMT) is the thickness of the two innermost layers of the arterial wall, intima and median in cm and will be measured through an ultrasound of the right common carotid artery. Specifically, a longitudinal B-mode image (Philips HDI 5000 ultrasound, 7-12 MHz linear array transducer) of the cephalic portion of the right common carotid artery will be obtained by a trained ultrasound technician. The composite IMT was calculated as the means of near and far wall IMT of all carotid segments, millimeters.
Measured: 0 weeks
Carotid intima-media thickness (cIMT)
Carotid intima-media thickness (cIMT) is the thickness of the two innermost layers of the arterial wall, intima and median in cm and will be measured through an ultrasound of the right common carotid artery. Specifically, a longitudinal B-mode image (Philips HDI 5000 ultrasound, 7-12 MHz linear array transducer) of the cephalic portion of the right common carotid artery will be obtained by a trained ultrasound technician. The composite IMT was calculated as the means of near and far wall IMT of all carotid segments, millimeters.
Measured: 24 weeks
Carotid intima-media thickness (cIMT)
Carotid intima-media thickness (cIMT) is the thickness of the two innermost layers of the arterial wall, intima and median in cm and will be measured through an ultrasound of the right common carotid artery. Specifically, a longitudinal B-mode image (Philips HDI 5000 ultrasound, 7-12 MHz linear array transducer) of the cephalic portion of the right common carotid artery will be obtained by a trained ultrasound technician. The composite IMT was calculated as the means of near and far wall IMT of all carotid segments, millimeters.
Measured: 52 weeks
Quality of life as measured by SF-12
Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100).
Measured: 0 weeks
Quality of life as measured by SF-12
Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100).
Measured: 24 weeks
Quality of life as measured by SF-12
Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100).
Measured: 52 weeks
Subjective Caregiver Burden
Subjective burden on informal caregivers will be measured using the short form of the Burden Scale for Family Caregivers (BSFC-s)-a 10-item instrument. Each item is measured on a four-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). A high degree of agreement indicates higher perception of burden by the caregiver.
Measured: 0 weeks
Subjective Caregiver Burden
Subjective burden on informal caregivers will be measured using the short form of the Burden Scale for Family Caregivers (BSFC-s)-a 10-item instrument. Each item is measured on a four-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). A high degree of agreement indicates higher perception of burden by the caregiver.
Measured: 24 weeks
Subjective Caregiver Burden
Subjective burden on informal caregivers will be measured using the short form of the Burden Scale for Family Caregivers (BSFC-s)-a 10-item instrument. Each item is measured on a four-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). A high degree of agreement indicates higher perception of burden by the caregiver.
Measured: 52 weeks
Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin
This is the ability of circulating vascular cell adhesion molecule-1 (VCAM-1), endothelial-leukocyte adhesion molecule-1 (E-selectin), and intercellular adhesion molecule-1 (ICAM-1) to serve as molecular markers of atherosclerosis and predictors of incident cardiovascular disease.
Measured: 0 weeks
Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin
This is the ability of circulating vascular cell adhesion molecule-1 (VCAM-1), endothelial-leukocyte adhesion molecule-1 (E-selectin), and intercellular adhesion molecule-1 (ICAM-1) to serve as molecular markers of atherosclerosis and predictors of incident cardiovascular disease.
Measured: 24 weeks
Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin
This is the ability of circulating vascular cell adhesion molecule-1 (VCAM-1), endothelial-leukocyte adhesion molecule-1 (E-selectin), and intercellular adhesion molecule-1 (ICAM-1) to serve as molecular markers of atherosclerosis and predictors of incident cardiovascular disease.
Measured: 52 weeks
Holter
Holter will be measured as part of the monitoring system. Participants will be provided with an appropriately sized ambulatory Holter monitoring device.
This is a cardiology study that records the heart's electrical activity for 24 hours or more, allowing the doctor to analyze the heart rhythm during the patient's daily activities.
Measured: 0 weeks
Holter
Holter will be measured as part of the monitoring system. Participants will be provided with an appropriately sized ambulatory Holter monitoring device.
This is a cardiology study that records the heart's electrical activity for 24 hours or more, allowing the doctor to analyze the heart rhythm during the patient's daily activities.
Measured: 24 weeks
Holter
Holter will be measured as part of the monitoring system. Participants will be provided with an appropriately sized ambulatory Holter monitoring device.
This is a cardiology study that records the heart's electrical activity for 24 hours or more, allowing the doctor to analyze the heart rhythm during the patient's daily activities.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20231 Dec 2026

First posted28 Aug 2019
Study start1 May 2023
Primary completion1 Dec 2025 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (42)Papers the sponsor has linked to this study.
Other trials for Cognitive DeclineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A double-blind randomized clinical trial entitled "Mind and Movement: Towards the Cognitive Health of Older Adults" will be conducted. The study will include two intervention groups and one control group: (1) a double-task exercise program with a squared mat led by a coach (a health professional) for 24 weeks (T1-GR); (2) the same exercise program led by a coach (a health professional) for 12 weeks and then led by caregivers of older adults for another 12 weeks (T2-GR); and (3) a control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04068376
Sponsor's protocol ID: 2018-785-095
Other IDs: 2023-3-146
Status last verified: Jun 2025
First submitted: 7 Aug 2019
Last updated: 19 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mimenza-Alvarado A, Aguilar-Navarro SG, Yeverino-Castro S, Mendoza-Franco C, Avila-Funes JA, Roman GC. Neuroimaging Characteristics of Small-Vessel Disease in Older Adults with Normal Cognition, Mild Cognitive Impairment, and Alzheimer Disease. Dement Geriatr Cogn Dis Extra. 2018 May 16;8(2):199-206. doi: 10.1159/000488705. eCollection 2018 May-Aug.
PubMed 29928288
Shigematsu R, Okura T. A novel exercise for improving lower-extremity functional fitness in the elderly. Aging Clin Exp Res. 2006 Jun;18(3):242-8. doi: 10.1007/BF03324655.
PubMed 16804371
Verghese J, LeValley A, Hall CB, Katz MJ, Ambrose AF, Lipton RB. Epidemiology of gait disorders in community-residing older adults. J Am Geriatr Soc. 2006 Feb;54(2):255-61. doi: 10.1111/j.1532-5415.2005.00580.x.
PubMed 16460376
Inzitari M, Metti A, Rosano C, Udina C, Perez LM, Carrizo G, Verghese J, Newman AB, Studenski S, Rosso AL. Qualitative neurological gait abnormalities, cardiovascular risk factors and functional status in older community-dwellers without neurological diseases: The Healthy Brain Project. Exp Gerontol. 2019 Sep;124:110652. doi: 10.1016/j.exger.2019.110652. Epub 2019 Jul 6.
PubMed 31288087
Trujillo AJ, Mroz TA, Piras C, Angeles G, Tran N. Caregiving and elderly health in Mexico. Int J Health Serv. 2012;42(4):667-94. doi: 10.2190/HS.42.4.f.
PubMed 23367799
Orgeta V, Miranda-Castillo C. Does physical activity reduce burden in carers of people with dementia? A literature review. Int J Geriatr Psychiatry. 2014 Aug;29(8):771-83. doi: 10.1002/gps.4060.
PubMed 25191688
Gregory MA, Boa Sorte Silva NC, Gill DP, McGowan CL, Liu-Ambrose T, Shoemaker JK, Hachinski V, Holmes J, Petrella RJ. Combined Dual-Task Gait Training and Aerobic Exercise to Improve Cognition, Mobility, and Vascular Health in Community-Dwelling Older Adults at Risk for Future Cognitive Decline1. J Alzheimers Dis. 2017;57(3):747-763. doi: 10.3233/JAD-161240.
PubMed 28304305
Boa Sorte Silva NC, Gregory MA, Gill DP, McGowan CL, Petrella RJ. The Impact of Blood Pressure Dipping Status on Cognition, Mobility, and Cardiovascular Health in Older Adults Following an Exercise Program. Gerontol Geriatr Med. 2018 Apr 23;4:2333721418770333. doi: 10.1177/2333721418770333. eCollection 2018 Jan-Dec.
PubMed 29761133
Gregory MA, Gill DP, Zou G, Liu-Ambrose T, Shigematsu R, Fitzgerald C, Hachinski V, Shoemaker K, Petrella RJ. Group-based exercise combined with dual-task training improves gait but not vascular health in active older adults without dementia. Arch Gerontol Geriatr. 2016 Mar-Apr;63:18-27. doi: 10.1016/j.archger.2015.11.008. Epub 2015 Dec 2.
PubMed 26791167
Kramer AF, Colcombe S. Fitness Effects on the Cognitive Function of Older Adults: A Meta-Analytic Study-Revisited. Perspect Psychol Sci. 2018 Mar;13(2):213-217. doi: 10.1177/1745691617707316.
PubMed 29592650
Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Plymate SR, Fishel MA, Watson GS, Cholerton BA, Duncan GE, Mehta PD, Craft S. Effects of aerobic exercise on mild cognitive impairment: a controlled trial. Arch Neurol. 2010 Jan;67(1):71-9. doi: 10.1001/archneurol.2009.307.
PubMed 20065132
Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
PubMed 18768414
Middleton L, Kirkland S, Rockwood K. Prevention of CIND by physical activity: different impact on VCI-ND compared with MCI. J Neurol Sci. 2008 Jun 15;269(1-2):80-4. doi: 10.1016/j.jns.2007.04.054. Epub 2008 Feb 20.
PubMed 18243244
Kelly ME, Loughrey D, Lawlor BA, Robertson IH, Walsh C, Brennan S. The impact of cognitive training and mental stimulation on cognitive and everyday functioning of healthy older adults: a systematic review and meta-analysis. Ageing Res Rev. 2014 May;15:28-43. doi: 10.1016/j.arr.2014.02.004. Epub 2014 Mar 4.
PubMed 24607830
Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.
PubMed 17179457

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-task Exercise Programs to Strengthen Cognitive and Vascular Health in Older Adults at Risk of Cognitive Decline: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04068376
Acronym / sponsor ID: 2018-785-095
Conditions: Cognitive Decline, Vascular Health
Keywords: cognitive decline, double task, older adults
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 300 participants (actual)
Lead sponsor: Instituto Mexicano del Seguro SocialOther government
Collaborators: School of Health and Sport Sciences, Chukyo University, Japan., Facultad de Estudios Superiores Aragón UNAM, university of chukyo, Faculty of Higher Studies UNAM
Study start: 1 May 2023 (actual)
Primary completion: 1 Dec 2025 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 28 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim: to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for older adults (OAs) at risk of cognitive decline - one program with and another without caregiver participation - and to compare these with an aerobic-balance-stretching exercise program (control group). 255 OAs (85 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 75 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups.
Study design: A double-blind randomized clinical trial entitled "Mind and Movement: Towards the Cognitive Health of Older Adults" will be conducted. The study will include two intervention groups and one control group: (1) a double-task exercise program with a squared mat led by a coach (a health professional) for 24 weeks (T1-GR); (2) the same exercise program led by a coach (a health professional) for 12 weeks and then led by caregivers of older adults for another 12 weeks (T2-GR); and (3) a control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).
Study hypothesis: The investigators hypothesize that T1 and T2 double-task exercise trainings will show more significant improvements in older adults than the control aerobic training with regards to (i) general cognitive function; (ii) specific cognitive functions (executive function, processing speed, verbal learning and memory, and verbal fluency); (iii) usual walking and dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) older adults' health-related quality of life; and (viii) caregiver burden.
Sample Size: It was calculated using the formula suggested by Zong (2009)32 for continuous outcome variable and non-inferiority design (2 [Z 1-α+Z 1-β/ δ] * S2). The investigators considered α <0.05, a power of 80%, and the assumptions to δ0 (a clinically acceptable margin) and S2(polled standard deviations of both comparison groups): General cognitive function=0.20(0.05), Mental flexibility (EF) part A=0.13(0.03) and B=0.37(0.37), Processing speed=0.06(0.02), Verbal learning=0.63(0.32) and memory=0.16(0.08), Verbal fluency words by category= 0.54 (0.14) and by letter=0.66 (0.17), Walking speed (cm/s)=0.23(0.06), Walking length(cm)=0.86(0.22), Systolic blood pressure(mmHg)=0.27(0.06); Diastolic blood pressure(mmHg)=0.79(0.40), Carotid intima-media thickness(mm)=0.20(0.05).Subjective burden on informal caregivers=0.53, Patient health-related quality of life (SF-36) Mental score=4.0(1.0) and Physical score=4.0(2.0). The maximum required sample size, assuming a possible 20% drop-out rate, is 85 participants per group.
Intervention implementation: The study will be conducted at IMSS Epidemiology and Health Services Research Unit facilities in Mexico City. The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health professional with a nursing background previously certified to coach SSE trainings by the Institute of Square-Stepping Exercise in Mie, Japan (Chief Tomohiro Okura and Overseas Director Professor Ryosuke Shigematsu). In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.
Compliance and adverse events monitoring A monitoring system will be developed to perform long-distance monitoring of compliance with physical activity. It will include three components: i) the system that will collect the information from a chipset connected to the SSE mats (e.g., time of exercise, velocity); ii) the system that will transmit and store the data on the study computer; iii) the system for supervision and follow-up, which will allow connecting with participants through different electronic devices, such as mobile phones and e-mails. The monitoring system will be an important strategy to avoid missing data, drop-out rates and low program adherence. In addition, the investigators will monitor study adverse events through direct observations of the study participants during the exercise sessions, monitoring system, and 12-, 24-, and 54-week evaluations. The investigators will register number, type (e.g., dizziness, pain, fatigue, muscle strains, falls, or injuries), and severity of adverse events during the exercise sessions and outside the hours of the exercise sessions but during the intervention period. The severity of events will be categorized as follows: mild (do not affect activities of daily living); moderate (have moderate effect on activities of daily living); and severe (requires hospitalization, or results in persistent or significant disability or results in some life-threatening, or other medically important condition). RSA and ABD will review all adverse events on a weekly basis. They will report all moderate and severe adverse events to the IMSS Ethics Committee and stop the study if the adverse events data demonstrate any hazard of the intervention.
Motivation strategies The monitoring system will be an important strategy to avoid drop-outs and low program adherence. It will be complemented by motivation phone calls to those participants who fail to attend the group sessions or to perform home-based SES activities. Moreover, the study will include 10-15 minute group discussions to explore health-related topics, such as the benefits of healthy lifestyles (e.g., physical activity, nutrition) to maintaining cardiovascular and brain health or to exchange experiences on past events. The discussions will precede exercise training sessions.
Evaluations The investigators will conduct four evaluations during the study: the baseline evaluation and 12-week, 24-week, and 52-week evaluations. The study outcome variables will be measured at each evaluation, while the covariates will be collected only at the beginning of the study. The investigators will also measure the participants' adherence to the programs, defined as 80% or higher compliance with the assigned exercise training regimen. Finally, the investigators will document the reasons for dropouts and poor adherence. Previously trained health professionals with a medical specialty in geriatrics will perform these evaluations. The study covariates will cover Participant demographic and clinical characteristics: age (years from birth); biological sex (male or female); formal educational attainment (years); current employment status (retired, employed, volunteer, unpaid worker, unemployed); marital status (married, widowed, divorced, single, other); and current living situation (living alone, living with a spouse, living with or without children); self-reported comorbidities relevant to this study (e.g., vascular risk factors, orthopedic conditions, etc.); and self-reported baseline physical activity defined as i) ideal (≥150 minutes per week of moderate-intensity activity or ≥75 minutes per week of vigorous-intensity activity, or an equivalent combination); ii) moderate/intermediate (≤149 minutes per week of moderate-intensity activity or ≤74 minutes per week of vigorous or intense activity, or an equivalent combination); and iii) poor (without any moderate or intense physical activity). The apolipoprotein E (APOE) ε4 allele is a genetic risk factor for Alzheimer's. Caregivers will be asked the following: age, biological sex, formal educational attainment, current employment status, marital status, relation to the patient, and self-reported baseline physical activity, as previously defined; availability of social support networks; and presence of animal companions at home. Social support will be measured using the Household and Family Support Networks subsection (part 5) of the World Health Organization Study on Global AGEing and Adult Health.
Data Management and confidentiality Data entry will be conducted by trained staff. Data quality will be assessed before statistical analysis (eg, range checks for data values). Only members of the study team will have access to the study information and all information that will be collected from participants will be kept private to ensure confidentiality. The consent forms with participant signatures will be stored in a locked location only accessible by the principal investigator (PI). All electronic data will be stored on the PI laptop and a back-up hard drive which will be password protected. Any handwritten information such as field notes or other related research materials will be stored and secured in a locked cabinet when not in use. Data will be erased and destroyed after 5 years, as per IMSS Ethics and Research Committee guidelines. Only deidentified data will be used for reporting, publication, and dissemination of findings.
Statistical Analysis First, the investigators will perform a descriptive analysis of the older adults' and caregivers' characteristics at each evaluation and evaluate the distribution of quantitative variables using the Kilmogorov-Smirnov normality test. Variables that have normal distribution will be analyzed using means and standard deviations, variables with non-normal distribution will be presented using medians and 25th and 75th percentiles, and categorical variables will be analyzed by using frequencies and percentages. Second, for each evaluation the investigators will compare study variables between T1-GR and C-GR and between T2-GR and C-GR. The comparison between these groups will be performed using Student's t-test (for normally distributed continuous variables), Mann Whitney-U test (for continuous variables that are not normally distributed), or Chi-square test (for categorical variables), as appropriate. The difference between baseline and post-intervention evaluations for each group will be measured using the Student's paired t-test or Mann-Whitney U test when the distribution is non-normal. The effect of the intervention on the outcome variables will be assessed by estimating the differences-in-differences (D-in-D) treatment effects using a D-in-D estimator.46 If the investigators identify statistically significant differences in participants' baseline characteristics and adherence to the exercise regimens among the studied groups, the model will adjust the results of the D-in-D treatment effects by these covariates using a generalized linear regression model (GLM), where Yi= ß0+ ß1Xi+ß2X+ ß3X +ßjCov +ei; in this regression equation, ß1 represents the mean difference within each group, β2 the mean change after the intervention, β3 the difference in mean change between the two groups (e.g., T1-GR and C-GR), ßjCov the covariates that were different between the study groups, and ei= the standard error. This model considers the correlation among repeated observations of the same subject and allows a more precise estimate to be obtained. The investigators will conduct a model for each outcome variables. P-values < 0.05 will be interpreted as statistically significant. The analyses will be performed using the software Stata 14.0 (Stata Corp, College Station, TX, USA).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: A double-blind randomized clinical trial entitled "Mind and Movement: Towards the Cognitive Health of Older Adults" will be conducted. The study will include two intervention groups and one control group: (1) a double-task exercise program with a squared mat led by a coach (a health professional) for 24 weeks (T1-GR); (2) the same exercise program led by a coach (a health professional) for 12 weeks and then led by caregivers of older adults for another 12 weeks (T2-GR); and (3) a control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).

Arm	Type	Receives
Control group (C-GR)	Active comparator	Other: "Mind and Movement for Cognitive Health in the Older Adult", Other: Double-task exercise by older adults and their caregiversControl group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).
T1-GR training sessions by health professional	Experimental	Other: Control excerciseThe T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health professional with a nursing background previously certified to coach SSE trainings by the Institute of Square-Stepping Exercise in Mie, Japan (Chief Tomohiro Okura and Overseas Director Professor Ryosuke Shigematsu).
T2-GR older adults and their caregivers	Experimental	Other: Control excerciseIn the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.

Who may qualify

Ages: 60 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

With 60-75 years of age.
They have self-reported cognitive concerns (ie, have answered "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?").
They demonstrate functional independence in activities of daily living and instrumental activities of daily living.
They have one or more vascular risk factors (eg, type 2 diabetes or hypertension).
They have symptoms or signs of underlying cognitive dysfunction without a diagnosis of dementia (ie, confirmed by a review of their health records and a Mini Mental State Exam [MMSE] score> 24).

Key exclusion criteria (7 listed)

With depression (score> 15 according to the Center for Epidemiological Studies Depression Scale - Revised [CESD-R]).
With clinically significant neurological or psychiatric disorders (eg, Parkinson's, schizophrenia).
With a recent severe cardiovascular event (eg, myocardial infarction, stroke).
With a major orthopedic condition (eg, severe osteoarthritis).
With blood pressure that is unsafe for exercise (ie,> 180/100 mmHg or <100/60 mmHg).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Control excerciseAlso: Aerobic-balance-stretching exercise programEach session will be for 60 minutes, 3 days a week, for 24 weeks. The make-up of each session is 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of balance-stretching exercise; and 5) 5 minutes of cool-down stretching (this times does not count as activity).	Other	T1-GR training sessions by health professional, T2-GR older adults and their caregivers
"Mind and Movement for Cognitive Health in the Older Adult"Also: Double-task exercise by a health professionalThe T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health profesional certified to coach SSE. The make-up of each session is: 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of double-task exercise (mat); and 5) 5 minutes of cool-down stretching (this times does not count as activity).	Other	Control group (C-GR)
Double-task exercise by older adults and their caregiversIn the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.	Other	Control group (C-GR)

Primary outcome

General Cognitive funtion
Time frame: 0 weeks
i) Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehens cognitive assessment, with total scores ranging from 0 to 69.
General Cognitive funtion
Time frame: 24 weeks
i) Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehensive cognitive assessment, with total scores ranging from 0 to 69.
General Cognitive funtion
Time frame: 52 weeks
i) Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehens cognitive assessment, with total scores ranging from 0 to 69.
Specific domains of cognitive function
Time frame: 0 weeks
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter. The frontal assessment battery (FAB)
Specific domains of cognitive function
Time frame: 24 weeks
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
Specific domains of cognitive function
Time frame: 52 weeks
Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
Cognitive reserve
Time frame: 0 weeks
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Cognitive reserve
Time frame: 24 weeks
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Cognitive reserve
Time frame: 52 weeks
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.

18 secondary outcomes

Usual walking and dual-task gait
Time frame: 0 weeks
Usual walking and dual-task gait
Time frame: 24 weeks
Usual walking and dual-task gait
Time frame: 52 weeks
Carotid intima-media thickness (cIMT)
Time frame: 0 weeks
Carotid intima-media thickness (cIMT)
Time frame: 24 weeks
Carotid intima-media thickness (cIMT)
Time frame: 52 weeks
Quality of life as measured by SF-12
Time frame: 0 weeks
Quality of life as measured by SF-12
Time frame: 24 weeks
Quality of life as measured by SF-12
Time frame: 52 weeks
Subjective Caregiver Burden
Time frame: 0 weeks
Subjective Caregiver Burden
Time frame: 24 weeks
Subjective Caregiver Burden
Time frame: 52 weeks
Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin
Time frame: 0 weeks
Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin
Time frame: 24 weeks
Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin
Time frame: 52 weeks
Holter
Time frame: 0 weeks
Holter
Time frame: 24 weeks
Holter
Time frame: 52 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Results publication: PubMed 29928288Mimenza-Alvarado A, Aguilar-Navarro SG, Yeverino-Castro S, Mendoza-Franco C, Avila-Funes JA, Roman GC. Neuroimaging Characteristics of Small-Vessel Disease in Older Adults with Normal Cognition, Mild Cognitive Impairment, and Alzheimer Disease. Dement Geriatr Cogn Dis Extra. 2018 May 16;8(2):199-206. doi: 10.1159/000488705. eCollection 2018 May-Aug.
Results publication: PubMed 16804371Shigematsu R, Okura T. A novel exercise for improving lower-extremity functional fitness in the elderly. Aging Clin Exp Res. 2006 Jun;18(3):242-8. doi: 10.1007/BF03324655.
Results publication: PubMed 16460376Verghese J, LeValley A, Hall CB, Katz MJ, Ambrose AF, Lipton RB. Epidemiology of gait disorders in community-residing older adults. J Am Geriatr Soc. 2006 Feb;54(2):255-61. doi: 10.1111/j.1532-5415.2005.00580.x.
Results publication: PubMed 31288087Inzitari M, Metti A, Rosano C, Udina C, Perez LM, Carrizo G, Verghese J, Newman AB, Studenski S, Rosso AL. Qualitative neurological gait abnormalities, cardiovascular risk factors and functional status in older community-dwellers without neurological diseases: The Healthy Brain Project. Exp Gerontol. 2019 Sep;124:110652. doi: 10.1016/j.exger.2019.110652. Epub 2019 Jul 6.
Results publication: PubMed 23367799Trujillo AJ, Mroz TA, Piras C, Angeles G, Tran N. Caregiving and elderly health in Mexico. Int J Health Serv. 2012;42(4):667-94. doi: 10.2190/HS.42.4.f.
Results publication: PubMed 25191688Orgeta V, Miranda-Castillo C. Does physical activity reduce burden in carers of people with dementia? A literature review. Int J Geriatr Psychiatry. 2014 Aug;29(8):771-83. doi: 10.1002/gps.4060.
Results publication: PubMed 28304305Gregory MA, Boa Sorte Silva NC, Gill DP, McGowan CL, Liu-Ambrose T, Shoemaker JK, Hachinski V, Holmes J, Petrella RJ. Combined Dual-Task Gait Training and Aerobic Exercise to Improve Cognition, Mobility, and Vascular Health in Community-Dwelling Older Adults at Risk for Future Cognitive Decline1. J Alzheimers Dis. 2017;57(3):747-763. doi: 10.3233/JAD-161240.
Results publication: PubMed 29761133Boa Sorte Silva NC, Gregory MA, Gill DP, McGowan CL, Petrella RJ. The Impact of Blood Pressure Dipping Status on Cognition, Mobility, and Cardiovascular Health in Older Adults Following an Exercise Program. Gerontol Geriatr Med. 2018 Apr 23;4:2333721418770333. doi: 10.1177/2333721418770333. eCollection 2018 Jan-Dec.
Results publication: PubMed 26791167Gregory MA, Gill DP, Zou G, Liu-Ambrose T, Shigematsu R, Fitzgerald C, Hachinski V, Shoemaker K, Petrella RJ. Group-based exercise combined with dual-task training improves gait but not vascular health in active older adults without dementia. Arch Gerontol Geriatr. 2016 Mar-Apr;63:18-27. doi: 10.1016/j.archger.2015.11.008. Epub 2015 Dec 2.
Results publication: PubMed 29592650Kramer AF, Colcombe S. Fitness Effects on the Cognitive Function of Older Adults: A Meta-Analytic Study-Revisited. Perspect Psychol Sci. 2018 Mar;13(2):213-217. doi: 10.1177/1745691617707316.
Results publication: PubMed 20065132Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Plymate SR, Fishel MA, Watson GS, Cholerton BA, Duncan GE, Mehta PD, Craft S. Effects of aerobic exercise on mild cognitive impairment: a controlled trial. Arch Neurol. 2010 Jan;67(1):71-9. doi: 10.1001/archneurol.2009.307.
Results publication: PubMed 18768414Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
Instituto Mexicano del Seguro Social. Informe al Ejecutivo Federal y al Congreso de la Unión Sobre la situación financiera y los riesgos del Instituto Mexicano del Seguro Social 2017-2018.Link provided by the sponsor.
Prueba de caminata de 6 minutos: recomendaciones y procedimientos.Link provided by the sponsor.
Consejo Nacional de Población. La situación demográfica de México 2017 (text in Spanish).Link provided by the sponsor.
Envejecimiento y dependencia. Realidades y previsión para los próximos años.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rosalinda Sánchez Arenas, PhD study director

Instituto Mexicano del Seguro Socil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General Cognitive funtion (time frame: 0 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04068376, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.