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

NCT ID: NCT06100835

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Physical Inactivity Sedentary Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being 65 years of age or above.
* Living in the community.
* No cognitive decline as per short form Mini-Mental State Examination (SMMSE).


* Being 65 years of age or above.
* Living in a nursing home.
* Ability to participate in group-based, structured PA.

Exclusion Criteria

\* Health condition that contraindicates physical exercise interventions (as per Physical Activity Readiness Questionnaire, PAR-Q).


* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

Fundació Blanquerna

UNKNOWN

Sponsor Role collaborator

Fundació Salut i Envelliment

UNKNOWN

Sponsor Role collaborator

Syddansk Universitet

UNKNOWN

Sponsor Role collaborator

Istituto Europeo per lo Sviluppo socio economico Associazione

UNKNOWN

Sponsor Role collaborator

Sport Initiative et Loisir Bleu Association

UNKNOWN

Sponsor Role collaborator

Agaplesion Bethesda Klinik Ulm

UNKNOWN

Sponsor Role collaborator

University of Vic - Central University of Catalonia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Coll-Planas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vic - Central University of Catalonia

Central Contacts

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Andrea Fuente-Vidal, PT, MSc

Role: CONTACT

+34938816025

Javier Jerez-Roig, PhD

Role: CONTACT

+34938816025

References

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Coll-Planas L, Fuente-Vidal A, Jerez-Roig J, Karkauskiene E, Romero-Mas M, Intxaurrondo A, Caserotti P, Skjodt M, Dallmeier D, Lefebvre G, Bassinah L, Forgione D, Castro R, Minobes-Molina E, Pares-Martinez C, Blancafort Alias S, Roman-Vinas B, Socorro-Cumplido JL, Nieto-Guisado A, Sansano-Nadal O, Gine-Garriga M. Boosting enjoyment and social inclusion to increase physical activity and reduce sedentary behaviour among older adults: protocol for a feasibility study to test the JOIN4JOY approach in five European countries. BMJ Open. 2024 Jul 27;14(7):e083291. doi: 10.1136/bmjopen-2023-083291.

Reference Type DERIVED
PMID: 39067876 (View on PubMed)

Related Links

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https://join4joy.eu/

Project official website

Other Identifiers

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Uvicucc_JOIN4JOY

Identifier Type: -

Identifier Source: org_study_id

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