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L'essai clinique NCT06100835 (JOIN4JOY) pour Inactivité physique, Comportement sédentaire est inconnu. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Feasibility of the JOIN4JOY Programme to Reduce Sedentary Behaviour and Increase Physical Activity in Older Adults.

Inconnu
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L'essai clinique NCT06100835 (JOIN4JOY) est conçu pour étudier le treatment de Inactivité physique, Comportement sédentaire. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : inconnu. L'essai a débuté le 1 décembre 2023 et vise à recruter 144 participants. Dirigé par University of Vic - Central University of Catalonia, l'essai devrait être terminé d'ici le 1 juin 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 3 novembre 2023.
Résumé succinct
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 détaillée
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.

Titre officiel

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

Conditions
Inactivité physiqueComportement sédentaire
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • JOIN4JOY
  • Uvicucc_JOIN4JOY
Numéro NCT
Date de début (réel)
2023-12
Dernière mise à jour publiée
2023-11-03
Date de fin (estimée)
2024-06
Inscription (estimée)
144
Type d'essai
Interventionnel
PHASE
Phase II
Statut
Inconnu
Mots clés
physical activity
joy
social inclusion
older adults
sedentary behaviour
sedentary behavior
nursing homes
enjoyment
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
N/A
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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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)
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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)
Critères d'éligibilité

Âges éligibles
Adulte âgé
Âge minimum
65 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • Being 65 years of age or above.
  • Living in the community.
  • No cognitive decline as per short form Mini-Mental State Examination (SMMSE).

* 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.
University of Vic - Central University of Catalonia logoUniversity of Vic - Central University of Catalonia
  • 🏛️European Commission
  • 🏛️Fundació Blanquerna
  • 🏛️Fundació Salut i Envelliment
  • 🎓Syddansk Universitet
  • 🏛️Istituto Europeo per lo Sviluppo socio economico Associazione
  • 🏛️Sport Initiative et Loisir Bleu Association
  • 🏛️Agaplesion Bethesda Klinik Ulm
Contact central de l'essai
Contact: Andrea Fuente-Vidal, PT, MSc, +34938816025, [email protected]
Contact: Javier Jerez-Roig, PhD, +34938816025, [email protected]
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