NCT06100835

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

September 7, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

physical activityjoysocial inclusionolder adultssedentary behavioursedentary behaviornursing homesenjoyment

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Physical function

    Before (week 0) and after (week 13)

  • Quality of life

    Before (week 0) and after (week 13)

  • Perceived improvement

    Before (week 0) and after (week 13)

  • Enjoyment

    After end of physical activity sessions (week 13)

  • Sense of community

    Before (week 0) and after (week 13)

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \* Health condition that contraindicates physical exercise interventions (as per Physical Activity Readiness Questionnaire, PAR-Q).
  • Being 65 years of age or above.
  • Living in a nursing home.
  • Ability to participate in group-based, structured PA.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivitySocial Inclusion

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Laura Coll-Planas, MD

    University of Vic - Central University of Catalonia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Fuente-Vidal, PT, MSc

CONTACT

Javier Jerez-Roig, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

October 25, 2023

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share