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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sedentary Behavior; Physical Inactivity
• Intervention / Treatment: Other: Complex intervention involving physical activity and behaviour change techniques

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andrea Fuente-Vidal, PT, MSc; Phone Number: +34938816025; Email: andrea.fuente@uvic.cat
• Study Contact Backup: Name: Javier Jerez-Roig, PhD; Phone Number: +34938816025; Email: javier.jerez@uvic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Physical activity	measured with de Physical Activity Questionnaire (IPAQ) - Short Form.	Before (week 0) and after (week 13)
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)
Sedentary Behavior	Assessed via the Sedentary Behaviour Questionnaire (SBQ),	Before (week 0) and after (Week 13)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Short Physical Performance Battery (SPPB) test,	Before (week 0) and after (week 13)
Quality of life	EUROQOL-5D-5L scale	Before (week 0) and after (week 13)
Perceived improvement	Patient Global Impression of Improvement (PGI-I) scale	Before (week 0) and after (week 13)
Enjoyment	Physical Activity Enjoyment Scale (PACES)	After end of physical activity sessions (week 13)
Sense of community	Sense of community index (SCI-2)	Before (week 0) and after (week 13)
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).
Quality of interactions in the virtual communities of practice	Assessed subjectively by the researchers	Through study completion and follow-up (estimated 6 months).
Degree of satisfaction	5-point Likert Scale	Post intervention (week 13)
Participation in physical activity sessions	Field diaries to be completed by trainers on a weekly basis	Intervention duration (weeks 1 through 12)

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia
• Collaborators: European Commission; Sport Initiative et Loisir Bleu Association; Syddansk Universitet; Fundació Blanquerna; Fundació Salut i Envelliment; Istituto Europeo per lo Sviluppo socio economico Associazione; Agaplesion Bethesda Klinik Ulm
• Investigators: Principal Investigator: Laura Coll-Planas, MD, University of Vic - Central University of Catalonia

Publications and helpful links

Helpful Links

• Project official website

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; older adults; sedentary behaviour; sedentary behavior; nursing homes; social inclusion; enjoyment; joy
• Other Study ID Numbers: Uvicucc_JOIN4JOY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No