跳至主要内容
临床试验/NCT06100835
NCT06100835Unknown2 期

Enjoy Physical Activity to Battle Sedentary Behaviour and Inactivity Among Older Adults From a Socially Inclusive Perspective (JOIN4JOY).

University of Vic - Central University of Catalonia0 个研究点目标入组 144 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
144
主要终点
Physical activity level

研究概览

简要总结

Physical activity (PA) and sedentary behavior (SB) programmes for older people in the community and long-term care facilities traditionally focus on achieving functional and health improvements. These approaches face frequent challenges in reaching older people with more social disadvantages and in achieving and maintaining attendance. The aim is to evaluate the acceptability, implementation process and potential impact of a co-created JOIN4JOY PA programme focused on enjoyment and social inclusion for 65+-year-old community-dwelling adults as well as for 65+-year-olds nursing-home residents who live in nursing homes.

详细描述

Physical activity (PA) and sedentary behavior (SB) programmes for older people in the community and long-term care facilities traditionally focus on achieving functional and health improvements. These approaches face frequent challenges in reaching older people with more social disadvantages and in achieving and maintaining attendance. The aim is to evaluate the acceptability, implementation process and potential impact of a co-created JOIN4JOY PA programme focused on enjoyment and social inclusion for 65+-year-old community-dwelling adults as well as for 65+-year-olds nursing-home residents who live in nursing homes.

Two related multicentric, pragmatic, feasibility studies using mixed methods will be conducted. The programme consists of a novel, co-created PA intervention focusing on enjoyment and social inclusion, grounded in self-management strategies to promote behaviour change. Participants will be offered one weekly, 1-hour session of structured, supervised PA and encouraged to hold more active lifestyles and engage in autonomous physical activity practice. Group sessions will take place in the participant's nursing home or in collaborating social institutions in the community.

Participants will additionally be invited to join virtual communities of practice. At least 72 end-users will be recruited for each setting in 5 European countries (i.e., Spain, Denmark and Italy will focus on the community settings while and Spain, Germany, and France will do so inon nursing homes). The implementation process and its acceptability will be assessed for acceptability, fidelity, participation and satisfaction by means ofwill be assessed by semi-structured interviews, field diaries of sessions and quantitative 5-point Likert-type scales. To evaluate the potential impact, physical function (Short Physical Performance Battery test), quality of life (EUROQOL-5D scale), enjoyment (Physical Activity Enjoyment Scale), perceived improvement (Patient Global Impression of Improvement scale), activities of daily living (Barthel index) and SB patterns (accelerometers) will be assessed. SPSS software will be used for the analysis of quantitative variables with paired t-tests. Qualitative data collected . Ppre- and post-intervention changes will be assessed using determined themathematic analysis following the steps described by of qualitative data.will follow the Braun and Clarke steps.

Ethics and dissemination: A favorable report by the Research Ethics Committee of UVic-UCC (282/2023) was obtained on June 26th, 2023. Participation and withdrawal will be voluntary. When necessary, written permission by the legal guardian will be requested. A broad action of dissemination and communication activities will be targetting both the scientific and the general public.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • for participants in JOIN4JOY-C include:
  • Being 65 years of age or above.
  • Living in the community.
  • No cognitive decline as per short form Mini-Mental State Examination (SMMSE).

排除标准

  • for participants in JOIN4JOY-C:
  • * Health condition that contraindicates physical exercise interventions (as per Physical Activity Readiness Questionnaire, PAR-Q).
  • Inclusion criteria for participants in JOIN4JOY-NH include:
  • Being 65 years of age or above.
  • Living in a nursing home.
  • Ability to participate in group-based, structured PA.
  • Exclusion criteria for participants in JOIN4JOY-NH include:
  • Severe cognitive decline (7 points or above as per Global Deterioration Scale of Reisberg, reported by professional caregivers).
  • Severe dependence that requires being bed-bound.

结局指标

主要结局

Physical activity level

时间窗: Before (week 0) and after (week 13)

Measured via Accelerometry . For 7 consecutive days before, and 7 consecutive days after the JOIN4JOY PA programme.

Self-reported Physical activity

时间窗: Before (week 0) and after (week 13)

measured with de Physical Activity Questionnaire (IPAQ) - Short Form.

Sedentary Behavior

时间窗: Before (week 0) and after (Week 13)

Assessed via the Sedentary Behaviour Questionnaire (SBQ),

次要结局

  • Physical function(Before (week 0) and after (week 13))
  • Quality of life(Before (week 0) and after (week 13))
  • Perceived improvement(Before (week 0) and after (week 13))
  • Sense of community(Before (week 0) and after (week 13))
  • Enjoyment(After end of physical activity sessions (week 13))
  • Participation in the virtual communities of practice(Through study completion and follow-up (estimated 6 months).)
  • Quality of interactions in the virtual communities of practice(Through study completion and follow-up (estimated 6 months).)
  • Degree of satisfaction(Post intervention (week 13))
  • Participation in physical activity sessions(Intervention duration (weeks 1 through 12))

研究者

发起方
University of Vic - Central University of Catalonia
申办方类型
Other
责任方
Sponsor

相似试验