Clinical trial NCT05721508: Cognitive and Physical Stimulation and Promotion of Social Relations for the Benefit of Older People's Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Poitiers
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 172
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Score at Trail Making Test (TMT)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at Stroop task
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at N-Back task
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at Montreal Cognitive Assessment (MoCA)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at letter comparison test (XO test)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at Remember-Know paradigm
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at 16-item Free and Cued Recall
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Score at Mill-Hill vocabulary test
timeFrame: Inclusion
measure: Change from baseline Score at Social Provisions Scale [SPS-10; score: 10-40]. (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at Rosenberg's Self-Esteem Scale [EES-10; score: 10-40] (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at French Achievement Goals Questionnaire for Sport and Exercise (QFBASEP) (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at 5-item World Health Organization well-being index [WHO-5; score: 0-100] (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at Mental Health Continuum Short Form [MHC-SF; score: 0-70] (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at anxiety item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at depression item on Hospital Anxiety and Depression Scale [HADS; score: 0-21] (self-report questionnaire)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Semi-structured interview
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at level of physical activity and sedentary lifestyle questionnaire (ONAPS)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at Dynamic balance and walking speed with Time Up and Go test
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at 30-second Chair Stand Test
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at arm Curl Test
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
measure: Change from baseline Score at six Minutes' Walk Test (6MWT)
timeFrame: inclusion; 6 weeks; 12weeks; 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University of Poitiers
Study officials:
affiliation: University of Poitiers
name: David Clarys
role: STUDY_DIRECTOR
References: