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

Aging Clinical Trial

— StimCoAPS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721508
• Other study ID #: AAPR2021-2020-12021410
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Poitiers
• Contact: Geoffroy Boucard
• Phone: 0549454696
• Email: geoffroy.boucard[@]univ-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
France	University of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
University of Poitiers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline Score at Stroop task	Score at cognitive inhibition function. higher scores mean a worse outcome.	inclusion; 6 weeks; 12weeks; 9 months
Primary	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
Primary	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
Primary	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
Primary	Change from baseline Score at Remember-Know paradigm	Score at episodic memory. Higher scores mean a better outcome	inclusion; 6 weeks; 12weeks; 9 months
Primary	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
Primary	Score at Mill-Hill vocabulary test	Score at crystallized intelligence. Higher scores mean a better outcome	Inclusion
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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