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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Other: Combined physical and cognitive program

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • University of Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual practice at home; Participants will undergo a training program combining physical and cognitive activities in individual practice at home.	Other: Combined physical and cognitive program; All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.
Experimental: Group practice in a traditional group environment (gymnasium); Participants will undergo a training program combining physical and cognitive activities in group practice in a traditional group environment (gymnasium).	Other: Combined physical and cognitive program; All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.
Experimental: Group practice in an enriched environment fostering social relations; Participants will undergo a training program combining physical and cognitive activities in group practice in an enriched environment fostering social relations.	Other: Combined physical and cognitive program; All participants will complete 12-week training sessions combining physical and cognitive activities, with two 1-hour sessions per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Score at Trail Making Test (TMT)	Score at cognitive flexibility function. higher scores mean a worse outcome.	inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Stroop task	Score at cognitive inhibition function. higher scores mean a worse outcome.	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	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	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	inclusion; 6 weeks; 12weeks; 9 months
Change from baseline Score at Remember-Know paradigm	Score at episodic memory. Higher scores mean a better outcome	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	inclusion; 6 weeks; 12weeks; 9 months
Score at Mill-Hill vocabulary test	Score at crystallized intelligence. Higher scores mean a better outcome	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.	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.	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)	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.	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.	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.	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.	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?"	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	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	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	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	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	inclusion; 6 weeks; 12weeks; 9 months

Collaborators and Investigators

• Sponsor: University of Poitiers
• Investigators: Study Director: David Clarys, University of Poitiers

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AAPR2021-2020-12021410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No