AgingNCT06052644
Assessing Cognitive and Health Improvements in the Elderly Via Exercise (ACHIEVE) - Study.
A study testing Exercise Dose-Response in people with Aging and Exercise, run by University of Jaén at 1 site in Colombia.
Trial summary
In Colombia, a demographic transition is occurring that is reflected in an inverted population pyramid, with an increase in the proportion of older adults due to a better quality of life, as well as a decrease in the young population due to the low birth rate. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Exercise Dose-Response
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteColombia
- Study dates
- 11 Jan 2024to 13 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women aged over 65 who voluntarily agree to participate in the study and are not engaged in any other physical exercise program
- Possess adequate physical autonomy to participate in the required physical activities for the study
- Exhibit mild cognitive impairment (with a score of <25 on the Mini-Mental State Examination)
- Have the capacity to comprehend the instructions, programs, and protocols of this trial.
Who cannot join
- People with contraindications for physical or exercise tests will be excluded. This includes individuals diagnosed with pathologies such as cancer, pulmonary hypertension, renal failure, heart failure, orphan diseases, psychiatric conditions, neurological or cognitive impairments, or Human Immunodeficiency Virus (HIV/AIDS) infection or disease.
- Individuals who do not consent to participate in the study or have declined to endorse the use of their data for research purposes in the informed consent at the time of program entry will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Cognitive and Health Improvements in the Elderly Via Exercise (ACHIEVE) Study - Optimal Exercise Dose-Response to Enhance Cognition and Physical Condition in Cognitively Impaired Older Adults.
In Colombia, a demographic transition is occurring that is reflected in an inverted population pyramid, with an increase in the proportion of older adults due to a better quality of life, as well as a decrease in the young population due to the low birth rate. These changes pose challenges for the healthcare system due to aging and its negative consequences for the body. The rate of aging has increased fourfold since 1950, which means a significant increase in the population of older adults compared to those under 15 years of age. Although exercise has been proven to have positive effects on the physical and cognitive health of older adults, there are still gaps in the literature concerning cognitive impairment in older adults, and the optimal dose to achieve maximum therapeutic potential has not been determined.
Therefore, the purpose of this research is to establish the optimal dose-response relationship to high-intensity exercise for improving cognition in older adults with mild cognitive impairment. A Randomized Controlled Clinical Trial with four groups will be conducted. One of the groups will serve as the control and will not receive treatment, focusing on occupational activities. The other three groups will be experimental, and the frequency and duration of exercise will be modified based on the World Health Organization (WHO) guidelines and a previous systematic research with meta-analysis. In the first experimental group (EG1), the WHO recommendations will be applied, consisting of 150 minutes of high-intensity exercise three times a week in sessions of 50 minutes each. In EG2, participants will perform high-intensity exercise twice a week, with a duration of 30 minutes per session. In EG3, high-intensity exercise will be performed four times per week in sessions of 50 minutes each. All experimental groups will receive high-intensity physical exercise interventions that combine aerobic and strength exercises adapted to the population. The sessions will be divided into three phases: warm-up, core phase, and cool-down.
Different sociodemographic, cognitive, and physical condition variables will be evaluated. All dependent variables will be measured before and after the intervention, and statistical analysis will determine which exercise prescription yielded the best results in terms of cognitive improvement. This research aims to provide valuable information about the optimal dose of high-intensity exercise to improve cognition in older adults with mild cognitive impairment in Colombia."
Read the detailed description
This research corresponds to an experimental study, a randomized single-blind controlled clinical trial, in which a total of 118 individuals, both men and women aged over 65, will participate. They will be divided into four groups: the control group (n = 31) and three experimental groups (n = 29 each). The variables will be measured for both groups using the same validated tools and evaluated by the same assessor to prevent information biases and differential misclassification. Evaluations will occur at the start of the intervention and immediately after its completion, with the results recorded in a data log. Subsequently, these results will be consolidated into an Excel database, with each participant assigned a code to ensure privacy while allowing for the necessary comparability.
Regarding the independent variables, we will address sociodemographic characteristics, clinical history, and the socio-familial assessment scale. As for the outcome variables, they are categorized into several areas: those related to health status will assess the relative risk of death due to comorbidity using the Charlson Comorbidity Index, health-related quality of life using the SF36 questionnaire, and Fried's frailty phenotype. Physical condition variables will be evaluated using the Senior Fitness Battery, gait and balance using the Tinetti Scale, and gait speed with the 6-minute walk test. Functional variables will be assessed using the Katz Index (activities of daily living), the Lawton \& Brody Index (instrumental activities of daily living), and Siu and Reuben's Physical Scale (advanced activities of daily living). For the cognitive variable, we will employ the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Attention and executive functions will be measured using the Trail Making Test Part A and Part B. Verbal fluency will be assessed with the Verbal Fluency Test (VFT), while selective attention and concentration will be evaluated using the D2 test. Processing speed will be determined through the Digit Symbol Substitution Test (DSST).
- Being tested
- Exercise Dose-Response
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Dose-ResponseOther
The intervention will last for 12 weeks. Depending on the group, participants will engage in the intervention either four times a week or only two times, with the duration ranging from 30 to 60 minutes per session. Each session will consist of three phases: an initial warm-up phase, a central phase, and a cool-down phase.
The warm-up phase will focus on joint mobility, beginning with flexion-extension, rotation, and lateral neck flexion while maintaining eye contact with a fixed point. This will be followed by trunk mobility exercises, including rotations.
The central phase will consist of aerobic and strength training performed at an intensity of 80-85% of the maximum heart rate. Each exercise will be performed intensely for 20 to 30 seconds, followed by a rest period of 10 to 15 seconds before repeating the exercise.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | No intervention | The control group will not carry out any type of intervention. You will receive physical activity recommendations from the Pan American Health Organization, developed by sports science professionals. |
| EXPERIMENTAL GROUP 1 (EG1) | Experimental | This group will engage in high-intensity physical exercise for 150 minutes per week, three days a week, with each session lasting 50 minutes. The session structure will include a 5-minute warm-up, 40 minutes of the core phase, and 5 minutes of cool down. Receives: Other: Exercise Dose-Response |
| EXPERIMENTAL GROUP 2 (EG2) | Experimental | Participants in this group will perform high-intensity exercise twice a week, with each session lasting 30 minutes. The session structure will include a 5-minute warm-up, 20 minutes of the core phase, and 5 minutes of cool down. Receives: Other: Exercise Dose-Response |
| EXPERIMENTAL GROUP 3 (EG3) | Experimental | This group will engage in high-intensity exercise four times a week, with each session lasting 50 minutes. The session structure will include a 5-minute warm-up, 40 minutes of the core phase, and 5 minutes of cool down. Receives: Other: Exercise Dose-Response |
What is being measured
The primary outcome is the main question the study is designed to answer.
General cognition
General cognition will be assessed with the Montreal Cognitive Assessment (MoCA), which evaluates executive and visuospatial function, memory, attention, language, abstraction, recall memory, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: Up to twelve weeks
Senior Fitness Battery (SFB)
Physical condition and functional capacity variables will be assessed using the Senior Fitness Battery (SFB). The SFB includes tests for upper and lower limb muscle strength (arm curl and chair stand tests, respectively), aerobic capacity (6-minute walk test), lower limb flexibility (sit-and-reach test), upper limb flexibility (back scratch test), and dynamic agility and balance (8-foot up-and-go test).
Measured: Up to twelve weeks
Secondary outcomes (1)
Trail Making Test part A and part B
Attention and executive functions will be evaluated using the Trail Making Test part A and part B (TMTA and TMTB, respectively). These tests involve timed visual and motor tasks where participants must connect numbered circles consecutively (TMTA) or alternate circles of numbers and letters (TMTB). TMTA assesses psychomotor attention and speed, as well as the ability to switch between different tasks or rule sets, while TMTB assesses executive function. A shorter time to connect all circles is indicative of better attention and executive function. An average score for TMT-A is 29 seconds and a deficient score is greater than 78 seconds. For TMT-B, an average score is 75 seconds and a deficient score is greater than 273 seconds.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start11 Jan 2024
- Primary completion20 May 2024
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052644
- Sponsor's protocol ID
- University of Jaén-
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cognitive and Health Improvements in the Elderly Via Exercise (ACHIEVE) Study - Optimal Exercise Dose-Response to Enhance Cognition and Physical Condition in Cognitively Impaired Older Adults.
- ClinicalTrials.gov ID
- NCT06052644
- Acronym / sponsor ID
- University of Jaén-
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 25 Sep 2023 (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.
In Colombia, a demographic transition is occurring that is reflected in an inverted population pyramid, with an increase in the proportion of older adults due to a better quality of life, as well as a decrease in the young population due to the low birth rate. These changes pose challenges for the healthcare system due to aging and its negative consequences for the body. The rate of aging has increased fourfold since 1950, which means a significant increase in the population of older adults compared to those under 15 years of age. Although exercise has been proven to have positive effects on the physical and cognitive health of older adults, there are still gaps in the literature concerning cognitive impairment in older adults, and the optimal dose to achieve maximum therapeutic potential has not been determined.
Therefore, the purpose of this research is to establish the optimal dose-response relationship to high-intensity exercise for improving cognition in older adults with mild cognitive impairment. A Randomized Controlled Clinical Trial with four groups will be conducted. One of the groups will serve as the control and will not receive treatment, focusing on occupational activities. The other three groups will be experimental, and the frequency and duration of exercise will be modified based on the World Health Organization (WHO) guidelines and a previous systematic research with meta-analysis. In the first experimental group (EG1), the WHO recommendations will be applied, consisting of 150 minutes of high-intensity exercise three times a week in sessions of 50 minutes each. In EG2, participants will perform high-intensity exercise twice a week, with a duration of 30 minutes per session. In EG3, high-intensity exercise will be performed four times per week in sessions of 50 minutes each. All experimental groups will receive high-intensity physical exercise interventions that combine aerobic and strength exercises adapted to the population. The sessions will be divided into three phases: warm-up, core phase, and cool-down.
Different sociodemographic, cognitive, and physical condition variables will be evaluated. All dependent variables will be measured before and after the intervention, and statistical analysis will determine which exercise prescription yielded the best results in terms of cognitive improvement. This research aims to provide valuable information about the optimal dose of high-intensity exercise to improve cognition in older adults with mild cognitive impairment in Colombia."
Detailed description
This research corresponds to an experimental study, a randomized single-blind controlled clinical trial, in which a total of 118 individuals, both men and women aged over 65, will participate. They will be divided into four groups: the control group (n = 31) and three experimental groups (n = 29 each). The variables will be measured for both groups using the same validated tools and evaluated by the same assessor to prevent information biases and differential misclassification. Evaluations will occur at the start of the intervention and immediately after its completion, with the results recorded in a data log. Subsequently, these results will be consolidated into an Excel database, with each participant assigned a code to ensure privacy while allowing for the necessary comparability.
Regarding the independent variables, we will address sociodemographic characteristics, clinical history, and the socio-familial assessment scale. As for the outcome variables, they are categorized into several areas: those related to health status will assess the relative risk of death due to comorbidity using the Charlson Comorbidity Index, health-related quality of life using the SF36 questionnaire, and Fried's frailty phenotype. Physical condition variables will be evaluated using the Senior Fitness Battery, gait and balance using the Tinetti Scale, and gait speed with the 6-minute walk test. Functional variables will be assessed using the Katz Index (activities of daily living), the Lawton \& Brody Index (instrumental activities of daily living), and Siu and Reuben's Physical Scale (advanced activities of daily living). For the cognitive variable, we will employ the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Attention and executive functions will be measured using the Trail Making Test Part A and Part B. Verbal fluency will be assessed with the Verbal Fluency Test (VFT), while selective attention and concentration will be evaluated using the D2 test. Processing speed will be determined through the Digit Symbol Substitution Test (DSST).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | No intervention | –The control group will not carry out any type of intervention. You will receive physical activity recommendations from the Pan American Health Organization, developed by sports science professionals. |
| EXPERIMENTAL GROUP 1 (EG1) | Experimental | Other: Exercise Dose-ResponseThis group will engage in high-intensity physical exercise for 150 minutes per week, three days a week, with each session lasting 50 minutes. The session structure will include a 5-minute warm-up, 40 minutes of the core phase, and 5 minutes of cool down. |
| EXPERIMENTAL GROUP 2 (EG2) | Experimental | Other: Exercise Dose-ResponseParticipants in this group will perform high-intensity exercise twice a week, with each session lasting 30 minutes. The session structure will include a 5-minute warm-up, 20 minutes of the core phase, and 5 minutes of cool down. |
| EXPERIMENTAL GROUP 3 (EG3) | Experimental | Other: Exercise Dose-ResponseThis group will engage in high-intensity exercise four times a week, with each session lasting 50 minutes. The session structure will include a 5-minute warm-up, 40 minutes of the core phase, and 5 minutes of cool down. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Men and women aged over 65 who voluntarily agree to participate in the study and are not engaged in any other physical exercise program
- Possess adequate physical autonomy to participate in the required physical activities for the study
- Exhibit mild cognitive impairment (with a score of <25 on the Mini-Mental State Examination)
- Have the capacity to comprehend the instructions, programs, and protocols of this trial.
Key exclusion criteria (2 listed)
- People with contraindications for physical or exercise tests will be excluded. This includes individuals diagnosed with pathologies such as cancer, pulmonary hypertension, renal failure, heart failure, orphan diseases, psychiatric conditions, neurological or cognitive impairments, or Human Immunodeficiency Virus (HIV/AIDS) infection or disease.
- Individuals who do not consent to participate in the study or have declined to endorse the use of their data for research purposes in the informed consent at the time of program entry will also be excluded.
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 |
|---|---|---|
| Exercise Dose-ResponseThe intervention will last for 12 weeks. Depending on the group, participants will engage in the intervention either four times a week or only two times, with the duration ranging from 30 to 60 minutes per session. Each session will consist of three phases: an initial warm-up phase, a central phase, and a cool-down phase. The warm-up phase will focus on joint mobility, beginning with flexion-extension, rotation, and lateral neck flexion while maintaining eye contact with a fixed point. This will be followed by trunk mobility exercises, including rotations. The central phase will consist of aerobic and strength training performed at an intensity of 80-85% of the maximum heart rate. Each exercise will be performed intensely for 20 to 30 seconds, followed by a rest period of 10 to 15 seconds before repeating the exercise. | Other | EXPERIMENTAL GROUP 1 (EG1), EXPERIMENTAL GROUP 2 (EG2), EXPERIMENTAL GROUP 3 (EG3) |
Primary outcome
General cognition
Time frame: Up to twelve weeks
General cognition will be assessed with the Montreal Cognitive Assessment (MoCA), which evaluates executive and visuospatial function, memory, attention, language, abstraction, recall memory, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Senior Fitness Battery (SFB)
Time frame: Up to twelve weeks
Physical condition and functional capacity variables will be assessed using the Senior Fitness Battery (SFB). The SFB includes tests for upper and lower limb muscle strength (arm curl and chair stand tests, respectively), aerobic capacity (6-minute walk test), lower limb flexibility (sit-and-reach test), upper limb flexibility (back scratch test), and dynamic agility and balance (8-foot up-and-go test).
1 secondary outcome
Trail Making Test part A and part B
Time frame: Up to twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Dose-Response in people with Aging and Exercise, run by University of Jaén at 1 site in Colombia.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Jul 2024. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cognition (time frame: Up to twelve weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2024.