AzTrials
AzTrials

Physical InactivityPhase 2JOIN4JOYNCT06100835

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

A Phase 2 study testing Complex intervention involving physical activity and behaviour change techniques in people with Physical Inactivity and Sedentary Behavior, run by University of Vic - Central University of Catalonia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Inactivity, Sedentary Behavior
What is being tested?
Complex intervention involving physical activity and behaviour change techniques
How many people
144 participants
Where
No sites listed yet
Study dates
Dec 2023to Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Andrea Fuente-Vidal, PT, MSc contact

+34938816025

andrea.fuente@uvic.cat

Javier Jerez-Roig, PhD contact

+34938816025

javier.jerez@uvic.cat

About this study

Official title: 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.

Read the 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.

Being tested
Complex intervention involving physical activity and behaviour change techniques
Keywords
physical activity, joy, social inclusion, older adults, sedentary behaviour, sedentary behavior, nursing homes, enjoyment
Medical subject headings
Sedentary Behavior, Motor Activity, Social Inclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complex intervention involving physical activity and behaviour change techniquesOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported Physical activity

    measured with de Physical Activity Questionnaire (IPAQ) - Short Form.

    Measured: Before (week 0) and after (week 13)

  2. Physical activity level

    Measured via Accelerometry . For 7 consecutive days before, and 7 consecutive days after the JOIN4JOY PA programme.

    Measured: Before (week 0) and after (week 13)

  3. Sedentary Behavior

    Assessed via the Sedentary Behaviour Questionnaire (SBQ),

    Measured: Before (week 0) and after (Week 13)

Secondary outcomes (9)

  1. Physical function

    Short Physical Performance Battery (SPPB) test,

    Measured: Before (week 0) and after (week 13)

  2. Quality of life

    EUROQOL-5D-5L scale

    Measured: Before (week 0) and after (week 13)

  3. Perceived improvement

    Patient Global Impression of Improvement (PGI-I) scale

    Measured: Before (week 0) and after (week 13)

  4. Enjoyment

    Physical Activity Enjoyment Scale (PACES)

    Measured: After end of physical activity sessions (week 13)

  5. Sense of community

    Sense of community index (SCI-2)

    Measured: Before (week 0) and after (week 13)

  6. Participation in the virtual communities of practice

    Number of entries in virtual communities of practice, per individual.

    Measured: Through study completion and follow-up (estimated 6 months).

  7. Quality of interactions in the virtual communities of practice

    Assessed subjectively by the researchers

    Measured: Through study completion and follow-up (estimated 6 months).

  8. Degree of satisfaction

    5-point Likert Scale

    Measured: Post intervention (week 13)

  9. Participation in physical activity sessions

    Field diaries to be completed by trainers on a weekly basis

    Measured: Intervention duration (weeks 1 through 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06100835
Sponsor's protocol ID
Uvicucc_JOIN4JOY
Acronym
JOIN4JOY
Status last verified
Nov 2023
First submitted
7 Sep 2023
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karkauskiene E, Coll-Planas L, Fuente-Vidal A, Sanchez D, Barth N, Dallmeier D, Socorro-Cumplido JL, Gine-Garriga M, Caserotti P, Lefebvre G, Jerez-Roig J. Feasibility, acceptability, and preliminary effects of the Join4Joy approach for older adults living in nursing homes: a multicentre mixed-methods feasibility study. Eur Geriatr Med. 2026 Aug 31. doi: 10.1007/s41999-026-01547-2. Online ahead of print.

    PubMed 42675296

  • 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.

    PubMed 39067876

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Complex intervention involving physical activity and behaviour change techniques in people with Physical Inactivity and Sedentary Behavior, run by University of Vic - Central University of Catalonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Fuente-Vidal, PT, MSc (+34938816025, andrea.fuente@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported Physical activity (time frame: Before (week 0) and after (week 13)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06100835, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in