NCT07703306

Brief Summary

FitSkills is an evidence based community based gym programme developed in Australia. It was developed in response to the barriers people with disability experience to accessing community-based physical activity. Within FitSkills, people with disability are paired with university students who act as a peer mentor. Pairs exercise together at a community gym location twice a week for 12 weeks. FitSkills has been shown to improve physical and social health among people with disabilities. FitSkills has not been delivered outside of Australia. The investigators are assessing how practical it is to deliver FitSkills in Ireland with the support of healthcare and physical activity professionals. The investigators want to understand the demand for this programme among young people with childhood-onset physical disability aged 13-24 years. In addition, the investigators want to learn if taking part in FitSkills influences exercise confidence and mental health and well-being among young people with childhood-onset physical disability.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

May 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 14, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 27, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

physical activityphysical disability

Outcome Measures

Primary Outcomes (9)

  • Participant recruitment (Reach)

    Participant recruitment (reach) will be assessed by the number of individuals who express interest in the study and the proportion who are eligible and enrolled. Additional descriptive data will be collected on recruitment, including the number of enquiries and completed expressions of interest, how participants heard about the study (e.g., healthcare professional referral, flyer, or other sources), eligibility outcomes (number eligible, number excluded, and reasons for exclusion), and basic demographic characteristics (age, gender, disability type, and location) of individuals expressing interest.

    Up to 6 months from study opening for recruitment

  • Adoption by healthcare and physical activity professionals

    Adoption will be assessed by the number and proportion of healthcare and physical activity professionals who are invited and agree to support implementation of the intervention. Additional descriptive data will be collected on professional characteristics (e.g., profession, service type, public or private service, and service location) and reasons for non-participation (e.g., work capacity constraints or lack of interest).

    Up to 7 months from first participant initiation of the intervention

  • Intervention Feasibility

    Intervention feasibility will be assessed by the proportion of participant pairs who complete the programme at 12 weeks. Additional descriptive data will be collected, including the number of pairs successfully matched (young people and student mentors), the number attending the group orientation session, and participant engagement (e.g., use of the challenge board). Fidelity to programme content and adverse events will be monitored and recorded using exercise log-books.

    Up to 7 months from first participant initiation of the intervention

  • Feasibility of the Intervention (Feasibility Intervention Measure)

    Feasibility will be assessed using the Feasibility of Intervention Measure (FIM), completed by healthcare and physical activity professionals following completion of their involvement in implementation. The FIM is a 4-item scale assessing perceived feasibility (e.g., whether the programme is possible, practical, and easy to implement), with responses rated on a 5-point Likert scale ranging from completely disagree to completely agree.

    At completion of professional involvement in intervention implementation (up to 7 months from first participant initiation)

  • Feasibility of collaboration between professionals

    Feasibility of collaboration between healthcare and physical activity professionals will be assessed using a communication logbook completed by professionals involved in implementation. The logbook will capture the number of contacts between professionals and characteristics of communication, including reason for contact, type of communication, and outcome of communication.

    Up to 7 months from first participant initiation of the intervention

  • Acceptability of the intervention among professionals

    Acceptability of the intervention will be assessed through online focus groups conducted with healthcare and physical activity professionals following implementation. Focus groups will explore participants' perceptions of the acceptability of the programme, including its perceived appropriateness, burden, and satisfaction with implementation.

    At completion of the intervention (up to 7 months from first participant initiation)

  • Acceptability of the intervention ( Acceptability of Intervention Measure)

    Acceptability will be assessed using the Acceptability of Intervention Measure (AIM), completed by healthcare and physical activity professionals. The AIM is a 4-item scale assessing perceived acceptability (e.g., whether the programme is appealing, meets approval, and is welcomed), with responses rated on a 5-point Likert scale ranging from completely disagree to completely agree.

    At completion of professional involvement in intervention implementation (up to 7 months from first participant initiation)

  • Appropriateness of the intervention ( Intervention Appropriateness Measure)

    Appropriateness will be assessed using the Intervention Appropriateness Measure (IAM), completed by healthcare and physical activity professionals. The IAM is a scale assessing perceived appropriateness (i.e., the extent to which the programme is suitable and relevant), with responses rated on a 5-point Likert scale ranging from completely disagree to completely agree.

    At completion of professional involvement in intervention implementation (up to 7 months from first participant initiation)

  • Acceptability of the intervention among young people

    Acceptability of the intervention will be assessed through online semi-structured interviews conducted with young people with disability who participated in the programme. Interviews will explore participants' perceptions of acceptability, including satisfaction with the programme, perceived benefits, and burden of participation.

    At completion of the intervention (up to 7 months from first participant initiation)

Secondary Outcomes (2)

  • Exercise self efficacy ( Exercise Self Efficacy Scale)

    Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)

  • Mental health and well-being (Mental Health Continuum-Short Form)

    Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)

Study Arms (1)

FitSkills

OTHER

FitSkills- Community-based physical activity programme

Other: Gym based exercise

Interventions

12 week community gym exercise programme. Twice weekly gym sessions for 60 minutes. Peer support provided by a third level healthcare student from host university. Standardised exercise programme developed by gym staff with support from the investigators. Goals and preferences of participants considered in programme development. This is the only intervention and there is no additional intervention provided

FitSkills

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Have a primary physical disability diagnosis, either congenital or acquired by age 15
  • Are aged between 13-24 years
  • Have not taken part in a regular gym programme in the previous 3 months (i.e. at least once a week for 3 months)
  • Can follow instructions in English
  • Are fit and well enough to participate in exercise

You may not qualify if:

  • Have an acute or concurrent medical condition rendering them unfit to participate in moderate-level physical activity
  • If they had an impaired ability to take part safely in a gym environment due to significant behavioural challenges.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Brady K, Ryan J, Cooper A, Shields N, Sofiany M, Malone A. Collaborative practice to support community-based physical activity for young people with childhood-onset physical disability: A scoping review. Dev Med Child Neurol. 2026 Feb 16. doi: 10.1111/dmcn.70209. Online ahead of print.

    PMID: 41699938BACKGROUND
  • Shields N, Cleary SL, McKenzie G, Hawke L, Bury S, Taylor NF. 'Have a go, you might surprise yourself': a qualitative study of the experiences of autistic adolescents and young adults of a community gym-based exercise programme. Disabil Rehabil. 2026 Feb 9:1-16. doi: 10.1080/09638288.2026.2627626. Online ahead of print.

    PMID: 41660938BACKGROUND
  • Shields N, Bhowon Y, Prendergast L, Cleary S, Taylor NF. Fostering positive attitudes towards interacting with young people with disability among health students: a stepped-wedge trial. Disabil Rehabil. 2024 Mar;46(6):1212-1219. doi: 10.1080/09638288.2023.2193429. Epub 2023 Apr 26.

    PMID: 37101339BACKGROUND
  • Shields N, Willis C, Imms C, Prendergast LA, Watts JJ, van Dorsselaer B, McKenzie G, Bruder AM, Taylor NF; FitSkills Partnership Project Group; FitSkills partnership project group. FitSkills: protocol for a stepped wedge cluster randomised trial of a community-based exercise programme to increase participation among young people with disability. BMJ Open. 2020 Jul 8;10(7):e037153. doi: 10.1136/bmjopen-2020-037153.

    PMID: 32641337BACKGROUND
  • Shields N, Willis C, Imms C, McKenzie G, van Dorsselaer B, Bruder AM, Kennedy RA, Bhowon Y, Southby A, Prendergast LA, Watts JJ, Taylor NF. Feasibility of scaling-up a community-based exercise program for young people with disability. Disabil Rehabil. 2022 May;44(9):1669-1681. doi: 10.1080/09638288.2021.1903103. Epub 2021 Mar 30.

    PMID: 33784487BACKGROUND
  • McKenzie G, Shields N, Willis C. 'Finding what works for me' - a qualitative study of factors influencing community gym participation for young adults with cerebral palsy. Disabil Rehabil. 2023 Jun;45(12):1984-1991. doi: 10.1080/09638288.2022.2083243. Epub 2022 Jun 12.

    PMID: 35694973BACKGROUND
  • Shields N, Bhowon Y, Willis C, Taylor NF, Bohingamu Mudiyanselage S, Watts JJ, Imms C, Prendergast LA. A community-based physical activity intervention (FitSkills) can improve participation attendance of young people with disability: a stepped wedge cluster randomised trial. Br J Sports Med. 2025 Oct 10;59(20):1426-1434. doi: 10.1136/bjsports-2025-109877.

    PMID: 40829864BACKGROUND
  • Shields N, Mizzi N, Buhlert-Smith K, Strydom A, Prendergast L, Hocking DR. A 12-week exercise programme has a positive effect on everyday executive function in young people with Down syndrome: a pilot non-randomised controlled trial. J Intellect Disabil Res. 2022 Dec;66(12):924-938. doi: 10.1111/jir.12979. Epub 2022 Sep 13.

    PMID: 36101998BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jennifer Ryan, PhD

CONTACT

Ailish Malone, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

July 14, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 14, 2026

Record last verified: 2026-05