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

Not Applicable

Recruiting

• Conditions: Aging
• Interventions: Other: Combined physical and cognitive program

• Registration Number: NCT05721508
• Lead Sponsor: University of Poitiers

Brief 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.

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 Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 159

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual practice at home	Combined physical and cognitive program	Participants will undergo a training program combining physical and cognitive activities in individual practice at home.
Group practice in a traditional group environment (gymnasium)	Combined physical and cognitive program	Participants 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	Combined physical and cognitive program	Participants will undergo a training program combining physical and cognitive activities in group practice in an enriched environment fostering social relations.

Primary Outcome Measures

Name	Time	Method
Change from baseline Score at N-Back task	inclusion; 6 weeks; 12weeks; 9 months	Score at working memory updating. Higher scores mean a better outcome
Change from baseline Score at Trail Making Test (TMT)	inclusion; 6 weeks; 12weeks; 9 months	Score at cognitive flexibility function. higher scores mean a worse outcome.
Change from baseline Score at Montreal Cognitive Assessment (MoCA)	inclusion; 6 weeks; 12weeks; 9 months	Score at basic cognitive functions. Higher scores mean a better outcome
Score at Mill-Hill vocabulary test	Inclusion	Score at crystallized intelligence. Higher scores mean a better outcome
Change from baseline Score at French Achievement Goals Questionnaire for Sport and Exercise (QFBASEP) (self-report questionnaire)	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)	inclusion; 6 weeks; 12weeks; 9 months	Perceived well-being Score (self-assessment). Higher scores mean a better outcome.
Change from baseline Score at Dynamic balance and walking speed with Time Up and Go test	inclusion; 6 weeks; 12weeks; 9 months	Dynamic balance and walking speed. A shorter time means a better result
Change from baseline Score at Social Provisions Scale [SPS-10; score: 10-40]. (self-report questionnaire)	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 30-second Chair Stand Test	inclusion; 6 weeks; 12weeks; 9 months	Score at lower body strength. Higher scores mean a better outcome
Change from baseline Score at Stroop task	inclusion; 6 weeks; 12weeks; 9 months	Score at cognitive inhibition function. higher scores mean a worse outcome.
Change from baseline Score at Remember-Know paradigm	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	inclusion; 6 weeks; 12weeks; 9 months	Score at episodic memory. 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)	inclusion; 6 weeks; 12weeks; 9 months	Anxiety Score (self-assessment). higher scores mean a worse outcome.
Change from baseline Score at letter comparison test (XO test)	inclusion; 6 weeks; 12weeks; 9 months	Score at processing-speed of information. Higher scores mean a better outcome
Change from baseline Score at Rosenberg's Self-Esteem Scale [EES-10; score: 10-40] (self-report questionnaire)	inclusion; 6 weeks; 12weeks; 9 months	Perceived self-esteem Score (self-assessment). Higher scores mean a better outcome.
Semi-structured interview	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)	inclusion; 6 weeks; 12weeks; 9 months	Level of physical activity and sedentary lifestyle
Change from baseline Score at Mental Health Continuum Short Form [MHC-SF; score: 0-70] (self-report questionnaire)	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 arm Curl Test	inclusion; 6 weeks; 12weeks; 9 months	Score at upper body strength. Higher scores mean a better outcome
Change from baseline Score at depression item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)	inclusion; 6 weeks; 12weeks; 9 months	Depression Score (self-assessment). higher scores mean a worse outcome.
Change from baseline Score at six Minutes' Walk Test (6MWT)	inclusion; 6 weeks; 12weeks; 9 months	Aerobic capacity. Higher distance traveled means a better result

Trial Locations

Locations (1)

University of Poitiers; 🇫🇷 Poitiers, France