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

NCT05721508 | Completed DMC

• 1 other identifier: AAPR2021-2020-12021410
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (3)

Individual practice at home

EXPERIMENTAL

Participants will undergo a training program combining physical and cognitive activities in individual practice at home.

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).

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.

Other: Combined physical and cognitive program

Interventions

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.

Group practice in a traditional group environment (gymnasium); Group practice in an enriched environment fostering social relations; Individual practice at home

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Poitiers: lead

Study Sites (1)

University of Poitiers

Poitiers, 86000, France

Location

Related Publications (1)

• 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.

  PMID: 37860154 DERIVED

Study Officials

• David Clarys

  University of Poitiers

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 10, 2023
• Study Start: January 20, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 21, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)