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Completed

NCT Number: NCT05721508

Cognitive and Physical Stimulation and Promotion of Social Relations for the Benefit of Older People's 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.

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Key information

Conditions

Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Poitiers

Poitiers, 86000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • People with contraindications for engaging in regular physical activity
  • People with severe neurological and psychological disorders.

Treatment and study plan

Combined physical and cognitive program

Other

All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Score at Mill-Hill vocabulary test

    Time frame: Inclusion

    Score at crystallized intelligence. Higher scores mean a better outcome

  9. 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.

  10. 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.

  11. 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)

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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?"

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

Sponsors and collaborators

Lead sponsor

University of Poitiers

Other

Registry information

Official study title

Effect of Practice Environment on Perceived Benefits of Combined Physical and Cognitive Program on Older People's Cognitive Abilities and Quality of Life

Acronym: StimCoAPS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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