Feasibility of the JOIN4JOY Programme to Reduce Sedentary Behaviour and Increase Physical Activity in Older Adults.

Physical Inactivity Clinical Trial

— JOIN4JOY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100835
• Other study ID #: Uvicucc_JOIN4JOY
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University of Vic - Central University of Catalonia
• Contact: Andrea Fuente-Vidal, PT, MSc
• Phone: +34938816025
• Email: andrea.fuente[@]uvic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physical Inactivity
• Sedentary Behavior

Intervention

Other:
• Complex intervention involving physical activity and behaviour change techniques
The intervention protocol derives from a previous, extensive, co-creation phase involving end-users as well as relatives, experts, professionals working working with older adults, university students and researchers. It will be based on a structured group-based PA programme supervised by trained professionals, tailored to participants' needs to include joyful components combined with self-management strategies to encourage behaviour change also beyond the sessions. All participants (including end-users but not only) will also be encouraged to join virtual communities of practice (VCoP) for further support and knowledge exchange.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia	Agaplesion Bethesda Klinik Ulm, European Commission, Fundació Blanquerna, Fundació Salut i Envelliment, Istituto Europeo per lo Sviluppo socio economico Associazione, Sport Initiative et Loisir Bleu Association, Syddansk Universitet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported Physical activity	measured with de Physical Activity Questionnaire (IPAQ) - Short Form.	Before (week 0) and after (week 13)
Primary	Physical activity level	Measured via Accelerometry . For 7 consecutive days before, and 7 consecutive days after the JOIN4JOY PA programme.	Before (week 0) and after (week 13)
Primary	Sedentary Behavior	Assessed via the Sedentary Behaviour Questionnaire (SBQ),	Before (week 0) and after (Week 13)
Secondary	Physical function	Short Physical Performance Battery (SPPB) test,	Before (week 0) and after (week 13)
Secondary	Quality of life	EUROQOL-5D-5L scale	Before (week 0) and after (week 13)
Secondary	Perceived improvement	Patient Global Impression of Improvement (PGI-I) scale	Before (week 0) and after (week 13)
Secondary	Enjoyment	Physical Activity Enjoyment Scale (PACES)	After end of physical activity sessions (week 13)
Secondary	Sense of community	Sense of community index (SCI-2)	Before (week 0) and after (week 13)
Secondary	Participation in the virtual communities of practice	Number of entries in virtual communities of practice, per individual.	Through study completion and follow-up (estimated 6 months).
Secondary	Quality of interactions in the virtual communities of practice	Assessed subjectively by the researchers	Through study completion and follow-up (estimated 6 months).
Secondary	Degree of satisfaction	5-point Likert Scale	Post intervention (week 13)
Secondary	Participation in physical activity sessions	Field diaries to be completed by trainers on a weekly basis	Intervention duration (weeks 1 through 12)

External Links

•   Project official website