Cognitive ImpairmentNCT06434857
Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults
A study testing Strength training in older adults with mild or non existent cognitive impairment and Multimodal excercise in older adults with mild or non existent cognitive impairment in people with Cognitive Impairment and Aging Problems, run by University of Salamanca at 1 site in Spain.
Trial summary
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of strength training, multimodal exercise with non-specific exercises and a control group on cognitive functionality and physical composition in subjects over 65 years of age with mild or non existent cognitive… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Aging Problems
- What is being tested?
- Strength training in older adults with mild or non existent cognitive impairment and Multimodal excercise in older adults with mild or non existent cognitive impairment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2024to 20 Feb 2026
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects older than 65
Who cannot join
- Absolute contraindication for excersice
- Severe cognitive impairment or dementia
- Language barriers
- Pending litigation or legal claim
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Salamanca
Salamanca, 37007
Arturo Dávila Marcos, +34605998329, turitodavila@usal.es
Arturo Dávila Marcos
About this study
Official title: Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults Undergoing an Occupational Therapy Program
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of strength training, multimodal exercise with non-specific exercises and a control group on cognitive functionality and physical composition in subjects over 65 years of age with mild or non existent cognitive impairment currently receiving occupational therapy.
The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Cognitive Functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), physical functionality (Timed up and go (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.
Read the detailed description
Design: Randomized, controlled clinical trial with three parallel groups, in which subjects over 65 years of age will be recruited. Study participants will be assigned to one of the three intervention groups. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, and a final one after 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes.
Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multimodal Exercise Group (GEM); 2) Strength Exercise Group (GES); 3) No Exercise Control Group (CG). The GEM and GES sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GES, only strength exercises will be performed.
Study population: 90 subjects over 65 years of age from the city of Salamanca will be recruited, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Cognitive functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), Physical Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed.
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.
The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
- Conditions
- Cognitive Impairment, Aging Problems
- Being tested
- Strength training in older adults with mild or non existent cognitive impairment, Multimodal excercise in older adults with mild or non existent cognitive impairment
- Keywords
- Aging, Cognitive impairment, Older adult, Strength training, Therapeutic exercise
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training in older adults with mild or non existent cognitive impairmentProcedure or surgery
Strength training program applied to strength training group
Multimodal excercise in older adults with mild or non existent cognitive impairmentProcedure or surgery
Multimodal exercise program applied to multimodal exercise group
| Study group | Role | What they receive |
|---|---|---|
| Strength Training Group | Experimental | The main part of the strength training program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, deadlifts, front and sagittal plan stride, and heel raises.
It will consist on different phases:
1. st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month.
2. nd phase: Resistance training: During the following seven months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course, increasing load and volume according to each subject's individual progress. Receives: Procedure: Strength training in older adults with mild or non existent cognitive impairment |
| Multimodal Exercise Group | Active comparator | The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises. Playful activities or games are also included.
Exercises will be turned gradually more demanding along the duration of the program. Receives: Procedure: Multimodal excercise in older adults with mild or non existent cognitive impairment |
| Control Group | No intervention | Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program, nor will they perform systematic, programmed and supervised physical exercise in any other program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functionality
Cognitive functionality will be measured with the Montreal Scales Assessment (MOCA). Maximum score is 30, considering a punctuation ≥ 26 is considered normal.
Measured: 8 months
Secondary outcomes (7)
Pittsburgh sleep quality index
A questionaire consisting of 7 items to screen sleep quality: subjective sleep quality,sleep latency, sleep duration, usual sleep efficiency, sleep perturbations, use of medication and daytime disfunction. Each item is scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 6 months
Athens insomnia scale
A shorter and simpler questionaire to quickly screen sleep quality. It consists of 8 components, each one scored from 0 to 3. Higher scores indicate worse sleep quality.
Measured: 6 months
Body Mass Index (BMI)
It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
Measured: 8 months
Short Physical Performance Battery (SPPB)
Test battery to assess physical performance and frailty degree consisting of 3 tests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
Measured: 8 months
Gait speed
It is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
Measured: 8 months
Timed Up and Go (TUG)
A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.
Measured: 8 months
Lawton & Brody Scale
A scale to evaluate functionality and independence in daily activities. It screens 8 items, ranged from 0 to 1. For women, a score of 8 is considered autonomous while for men the score is 5.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start15 Sep 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Randomized, controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Dávila Marcos, University of Salamanca
- Investigators
- Arturo Dávila Marcos, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434857
- Sponsor's protocol ID
- 16069701
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults Undergoing an Occupational Therapy Program
- ClinicalTrials.gov ID
- NCT06434857
- Acronym / sponsor ID
- 16069701
- Conditions
- Cognitive Impairment, Aging Problems
- Keywords
- Aging, Cognitive impairment, Older adult, Strength training, Therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 30 May 2024 (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.
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of strength training, multimodal exercise with non-specific exercises and a control group on cognitive functionality and physical composition in subjects over 65 years of age with mild or non existent cognitive impairment currently receiving occupational therapy.
The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Cognitive Functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), physical functionality (Timed up and go (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.
Detailed description
Design: Randomized, controlled clinical trial with three parallel groups, in which subjects over 65 years of age will be recruited. Study participants will be assigned to one of the three intervention groups. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, and a final one after 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes.
Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multimodal Exercise Group (GEM); 2) Strength Exercise Group (GES); 3) No Exercise Control Group (CG). The GEM and GES sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GES, only strength exercises will be performed.
Study population: 90 subjects over 65 years of age from the city of Salamanca will be recruited, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Cognitive functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), Physical Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed.
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.
The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Strength Training Group | Experimental | Procedure: Strength training in older adults with mild or non existent cognitive impairmentThe main part of the strength training program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, deadlifts, front and sagittal plan stride, and heel raises. It will consist on different phases: 1. st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month. 2. nd phase: Resistance training: During the following seven months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course, increasing load and volume according to each subject's individual progress. |
| Multimodal Exercise Group | Active comparator | Procedure: Multimodal excercise in older adults with mild or non existent cognitive impairmentThe main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises. Playful activities or games are also included. Exercises will be turned gradually more demanding along the duration of the program. |
| Control Group | No intervention | –Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program, nor will they perform systematic, programmed and supervised physical exercise in any other program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects older than 65
Key exclusion criteria (4 listed)
- Absolute contraindication for excersice
- Severe cognitive impairment or dementia
- Language barriers
- Pending litigation or legal claim
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 |
|---|---|---|
| Strength training in older adults with mild or non existent cognitive impairmentStrength training program applied to strength training group | Procedure or surgery | Strength Training Group |
| Multimodal excercise in older adults with mild or non existent cognitive impairmentMultimodal exercise program applied to multimodal exercise group | Procedure or surgery | Multimodal Exercise Group |
Primary outcome
Cognitive functionality
Time frame: 8 months
Cognitive functionality will be measured with the Montreal Scales Assessment (MOCA). Maximum score is 30, considering a punctuation ≥ 26 is considered normal.
7 secondary outcomes
Pittsburgh sleep quality index
Time frame: 6 months
Athens insomnia scale
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 8 months
Short Physical Performance Battery (SPPB)
Time frame: 8 months
Gait speed
Time frame: 8 months
Timed Up and Go (TUG)
Time frame: 8 months
Lawton & Brody Scale
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- 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.
Arturo Dávila Marcos principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in older adults with mild or non existent cognitive impairment and Multimodal excercise in older adults with mild or non existent cognitive impairment in people with Cognitive Impairment and Aging Problems, run by University of Salamanca at 1 site in Spain.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 May 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arturo Dávila Marcos (+34605998329, turitodavila@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functionality (time frame: 8 months). 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 30 May 2024.