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临床试验/NCT05721508
NCT05721508已完成不适用

Effect of Practice Environment on Perceived Benefits of Combined Physical and Cognitive Program on Older People's Cognitive Abilities and Quality of Life

University of Poitiers2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2022年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
2
主要终点
Change from baseline Score at Trail Making Test (TMT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Change from baseline Score at Trail Making Test (TMT)

时间窗: 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)

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Score at basic cognitive functions. Higher scores mean a better outcome

Score at Mill-Hill vocabulary test

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Dynamic balance and walking speed. A shorter time means a better result

Change from baseline Score at N-Back task

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Score at working memory updating. Higher scores mean a better outcome

Change from baseline Score at Social Provisions Scale [SPS-10; score: 10-40]. (self-report questionnaire)

时间窗: 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 Stroop task

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Perceived self-esteem Score (self-assessment). Higher scores mean a better outcome.

Semi-structured interview

时间窗: 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)

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Level of physical activity and sedentary lifestyle

Change from baseline Score at 30-second Chair Stand Test

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Score at lower body strength. Higher scores mean a better outcome

Change from baseline Score at Mental Health Continuum Short Form [MHC-SF; score: 0-70] (self-report questionnaire)

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: inclusion; 6 weeks; 12weeks; 9 months

Aerobic capacity. Higher distance traveled means a better result

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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