Clinical trial NCT06100835: Feasibility of the JOIN4JOY Programme to Reduce Sedentary Behaviour and Increase Physical Activity in Older Adults.
Official title: Enjoy Physical Activity to Battle Sedentary Behaviour and Inactivity Among Older Adults From a Socially Inclusive Perspective (JOIN4JOY).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Physical Inactivity
Sedentary Behavior
Keywords: physical activity
joy
social inclusion
older adults
sedentary behaviour
sedentary behavior
nursing homes
enjoyment
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: European Commission
name: Fundació Blanquerna
name: Fundació Salut i Envelliment
name: Syddansk Universitet
name: Istituto Europeo per lo Sviluppo socio economico Associazione
name: Sport Initiative et Loisir Bleu Association
name: Agaplesion Bethesda Klinik Ulm
First posted: 2023-10-25
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria 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).

Exclusion criteria 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.

Primary outcomes:
measure: Self-reported Physical activity
timeFrame: Before (week 0) and after (week 13)
measure: Physical activity level
timeFrame: Before (week 0) and after (week 13)
measure: Sedentary Behavior
timeFrame: Before (week 0) and after (Week 13)
Secondary outcomes:
measure: Physical function
timeFrame: Before (week 0) and after (week 13)
measure: Quality of life
timeFrame: Before (week 0) and after (week 13)
measure: Perceived improvement
timeFrame: Before (week 0) and after (week 13)
measure: Enjoyment
timeFrame: After end of physical activity sessions (week 13)
measure: Sense of community
timeFrame: Before (week 0) and after (week 13)
measure: Participation in the virtual communities of practice
timeFrame: Through study completion and follow-up (estimated 6 months).
measure: Quality of interactions in the virtual communities of practice
timeFrame: Through study completion and follow-up (estimated 6 months).
measure: Degree of satisfaction
timeFrame: Post intervention (week 13)
measure: Participation in physical activity sessions
timeFrame: Intervention duration (weeks 1 through 12)
Other outcomes:
Locations:
Study officials:
affiliation: University of Vic - Central University of Catalonia
name: Laura Coll-Planas, MD
role: PRINCIPAL_INVESTIGATOR
References: