AgingStimCoAPSNCT05721508
Cognitive and Physical Stimulation and Promotion of Social Relations for the Benefit of Older People's Quality of Life
A study testing Combined physical and cognitive program in people with Aging, run by University of Poitiers at 1 site in France.
Trial summary
The aim of this interventional study is thus to assess and highlight the cognitive, physical, and psychosocial benefits of a combined physical and cognitive training program in an enriched environment and to assess the factors influencing these benefits. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Combined physical and cognitive program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2022to 21 Dec 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- People must be at least 65 years old
- People must be at independent (able to get around on their own: car, bus, walking)
- People must be at living in the community (not in an institution such as a nursing home)
- The persons recruited must have a score on the Montreal Cognitive Assessment (MoCA) of at least 18.
Who cannot join
- People with contraindications for engaging in regular physical activity
- People with severe neurological and psychological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Practice Environment on Perceived Benefits of Combined Physical and Cognitive Program on Older People's Cognitive Abilities and Quality of Life
The aim of this interventional study is thus to assess and highlight the cognitive, physical, and psychosocial benefits of a combined physical and cognitive training program in an enriched environment and to assess the factors influencing these benefits.
Read the detailed description
The number of older people worldwide is constantly increasing. However, one of the main problems associated with aging is cognitive decline, which affects essential everyday functions such as memory, attention, and executive functions. Thus, maintaining autonomy and quality of life depends on physical health, and the integrity of cognitive functioning. Cognitive, physical and social activities can all slow this decline but social factors and their contribution to the well-being of older people remain under-researched. The aim of the present study is to analyze how the practice environment can foster these social relations and thus enhance wellbeing and to identify the psychological dimensions that are activated by social relations.
- Conditions
- Aging
- Being tested
- Combined physical and cognitive program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined physical and cognitive programOther
All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Individual practice at home | Experimental | Participants will undergo a training program combining physical and cognitive activities in individual practice at home. Receives: Other: Combined physical and cognitive program |
| Group practice in a traditional group environment (gymnasium) | Experimental | Participants will undergo a training program combining physical and cognitive activities in group practice in a traditional group environment (gymnasium). Receives: Other: Combined physical and cognitive program |
| Group practice in an enriched environment fostering social relations | Experimental | Participants will undergo a training program combining physical and cognitive activities in group practice in an enriched environment fostering social relations. Receives: Other: Combined physical and cognitive program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Score at Trail Making Test (TMT)
Score at cognitive flexibility function. higher scores mean a worse outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Stroop task
Score at cognitive inhibition function. higher scores mean a worse outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at N-Back task
Score at working memory updating. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Montreal Cognitive Assessment (MoCA)
Score at basic cognitive functions. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at letter comparison test (XO test)
Score at processing-speed of information. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Remember-Know paradigm
Score at episodic memory. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at 16-item Free and Cued Recall
Score at episodic memory. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Score at Mill-Hill vocabulary test
Score at crystallized intelligence. Higher scores mean a better outcome
Measured: Inclusion
Change from baseline Score at Social Provisions Scale [SPS-10; score: 10-40]. (self-report questionnaire)
Perceived social support Score (attachment, social integration, confirmation of one's value, material help, orientation) (self-assessment). Higher scores mean a better outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Rosenberg's Self-Esteem Scale [EES-10; score: 10-40] (self-report questionnaire)
Perceived self-esteem Score (self-assessment). Higher scores mean a better outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at French Achievement Goals Questionnaire for Sport and Exercise (QFBASEP) (self-report questionnaire)
Goal of motivation for physical activity (self-assessment)
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at 5-item World Health Organization well-being index [WHO-5; score: 0-100] (self-report questionnaire)
Perceived well-being Score (self-assessment). Higher scores mean a better outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Mental Health Continuum Short Form [MHC-SF; score: 0-70] (self-report questionnaire)
Perceived emotional, social and psychological well-being Score (self-assessment). Higher scores mean a better outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at anxiety item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
Anxiety Score (self-assessment). higher scores mean a worse outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at depression item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
Depression Score (self-assessment). higher scores mean a worse outcome.
Measured: inclusion; 6 weeks; 12weeks; 9 months
Semi-structured interview
Assessment of social and cultural life, and assessment of interactions and relations with group members or teachers: "How would you describe your social and cultural life now?", "How the sessions with the other members of the group going?"
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at level of physical activity and sedentary lifestyle questionnaire (ONAPS)
Level of physical activity and sedentary lifestyle
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Dynamic balance and walking speed with Time Up and Go test
Dynamic balance and walking speed. A shorter time means a better result
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at 30-second Chair Stand Test
Score at lower body strength. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at arm Curl Test
Score at upper body strength. Higher scores mean a better outcome
Measured: inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at six Minutes' Walk Test (6MWT)
Aerobic capacity. Higher distance traveled means a better result
Measured: inclusion; 6 weeks; 12weeks; 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start20 Jan 2022
- Primary completion20 Dec 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Poitiers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Clarys, Study director, University of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721508
- Sponsor's protocol ID
- AAPR2021-2020-12021410
- Acronym
- StimCoAPS
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonnord T, Clarys D; StimCoAPS Consortium; Dupuy O, Albouy M, Migeot V, Grangeiro R, Esnard C, Boucard G. Effects of combined physical and cognitive program performed in socially enriched environment on older people's cognitive abilities and quality of life (StimCoAPS): study protocol for a randomized controlled trial. BMJ Open Sport Exerc Med. 2023 Oct 11;9(4):e001577. doi: 10.1136/bmjsem-2023-001577. eCollection 2023.
PubMed 37860154
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Practice Environment on Perceived Benefits of Combined Physical and Cognitive Program on Older People's Cognitive Abilities and Quality of Life
- ClinicalTrials.gov ID
- NCT05721508
- Acronym / sponsor ID
- StimCoAPS / AAPR2021-2020-12021410
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of PoitiersUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 10 Feb 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.
The aim of this interventional study is thus to assess and highlight the cognitive, physical, and psychosocial benefits of a combined physical and cognitive training program in an enriched environment and to assess the factors influencing these benefits.
Detailed description
The number of older people worldwide is constantly increasing. However, one of the main problems associated with aging is cognitive decline, which affects essential everyday functions such as memory, attention, and executive functions. Thus, maintaining autonomy and quality of life depends on physical health, and the integrity of cognitive functioning. Cognitive, physical and social activities can all slow this decline but social factors and their contribution to the well-being of older people remain under-researched. The aim of the present study is to analyze how the practice environment can foster these social relations and thus enhance wellbeing and to identify the psychological dimensions that are activated by social relations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual practice at home | Experimental | Other: Combined physical and cognitive programParticipants will undergo a training program combining physical and cognitive activities in individual practice at home. |
| Group practice in a traditional group environment (gymnasium) | Experimental | Other: Combined physical and cognitive programParticipants will undergo a training program combining physical and cognitive activities in group practice in a traditional group environment (gymnasium). |
| Group practice in an enriched environment fostering social relations | Experimental | Other: Combined physical and cognitive programParticipants will undergo a training program combining physical and cognitive activities in group practice in an enriched environment fostering social relations. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People must be at least 65 years old
- People must be at independent (able to get around on their own: car, bus, walking)
- People must be at living in the community (not in an institution such as a nursing home)
- The persons recruited must have a score on the Montreal Cognitive Assessment (MoCA) of at least 18.
Key exclusion criteria (2 listed)
- People with contraindications for engaging in regular physical activity
- People with severe neurological and psychological disorders.
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 |
|---|---|---|
| Combined physical and cognitive programAll participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week. | Other | Group practice in a traditional group environment (gymnasium), Group practice in an enriched environment fostering social relations, Individual practice at home |
Primary outcome
Change from baseline Score at Trail Making Test (TMT)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at cognitive flexibility function. higher scores mean a worse outcome.
Change from baseline Score at Stroop task
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at cognitive inhibition function. higher scores mean a worse outcome.
Change from baseline Score at N-Back task
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at working memory updating. Higher scores mean a better outcome
Change from baseline Score at Montreal Cognitive Assessment (MoCA)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at basic cognitive functions. Higher scores mean a better outcome
Change from baseline Score at letter comparison test (XO test)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at processing-speed of information. Higher scores mean a better outcome
Change from baseline Score at Remember-Know paradigm
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at episodic memory. Higher scores mean a better outcome
Change from baseline Score at 16-item Free and Cued Recall
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at episodic memory. Higher scores mean a better outcome
Score at Mill-Hill vocabulary test
Time frame: Inclusion
Score at crystallized intelligence. Higher scores mean a better outcome
Change from baseline Score at Social Provisions Scale [SPS-10; score: 10-40]. (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived social support Score (attachment, social integration, confirmation of one's value, material help, orientation) (self-assessment). Higher scores mean a better outcome.
Change from baseline Score at Rosenberg's Self-Esteem Scale [EES-10; score: 10-40] (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived self-esteem Score (self-assessment). Higher scores mean a better outcome.
Change from baseline Score at French Achievement Goals Questionnaire for Sport and Exercise (QFBASEP) (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Goal of motivation for physical activity (self-assessment)
Change from baseline Score at 5-item World Health Organization well-being index [WHO-5; score: 0-100] (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived well-being Score (self-assessment). Higher scores mean a better outcome.
Change from baseline Score at Mental Health Continuum Short Form [MHC-SF; score: 0-70] (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Perceived emotional, social and psychological well-being Score (self-assessment). Higher scores mean a better outcome.
Change from baseline Score at anxiety item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Anxiety Score (self-assessment). higher scores mean a worse outcome.
Change from baseline Score at depression item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Depression Score (self-assessment). higher scores mean a worse outcome.
Semi-structured interview
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Assessment of social and cultural life, and assessment of interactions and relations with group members or teachers: "How would you describe your social and cultural life now?", "How the sessions with the other members of the group going?"
Change from baseline Score at level of physical activity and sedentary lifestyle questionnaire (ONAPS)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Level of physical activity and sedentary lifestyle
Change from baseline Score at Dynamic balance and walking speed with Time Up and Go test
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Dynamic balance and walking speed. A shorter time means a better result
Change from baseline Score at 30-second Chair Stand Test
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at lower body strength. Higher scores mean a better outcome
Change from baseline Score at arm Curl Test
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Score at upper body strength. Higher scores mean a better outcome
Change from baseline Score at six Minutes' Walk Test (6MWT)
Time frame: inclusion; 6 weeks; 12weeks; 9 months
Aerobic capacity. Higher distance traveled means a better result
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 28 Mar 2025.
- Derived from this study: PubMed 37860154Gonnord T, Clarys D; StimCoAPS Consortium; Dupuy O, Albouy M, Migeot V, Grangeiro R, Esnard C, Boucard G. Effects of combined physical and cognitive program performed in socially enriched environment on older people's cognitive abilities and quality of life (StimCoAPS): study protocol for a randomized controlled trial. BMJ Open Sport Exerc Med. 2023 Oct 11;9(4):e001577. doi: 10.1136/bmjsem-2023-001577. eCollection 2023.
- 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.
David Clarys study director
University of Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined physical and cognitive program in people with Aging, run by University of Poitiers at 1 site in France.
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 28 Mar 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 France. 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?
Change from baseline Score at Trail Making Test (TMT) (time frame: inclusion; 6 weeks; 12weeks; 9 months). The study lists 21 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 NCT05721508, which also lists 1 linked publication.
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 28 Mar 2025.