- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703306
Acceptability of FitSkills in the Irish Context for Young People With Childhood-onset Physical Disability
The Feasibility and Acceptability of Translating FitSkills to the Irish Context to Facilitate Physical Activity Participation for Young People With Childhood-onset Physical Disability
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Ryan, PhD
- Phone Number: 014022413
- Email: jenniferryan@rcsi.com
Study Contact Backup
- Name: Ailish Malone, PhD
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: FitSkills
FitSkills- Community-based physical activity programme
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant recruitment (Reach)
Time Frame: Up to 6 months from study opening for recruitment
|
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
Time Frame: Up to 7 months from first participant initiation of the intervention
|
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
Time Frame: Up to 7 months from first participant initiation of the intervention
|
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)
Time Frame: At completion of professional involvement in intervention implementation (up to 7 months from first participant initiation)
|
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
Time Frame: Up to 7 months from first participant initiation of the intervention
|
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
Time Frame: At completion of the intervention (up to 7 months from first participant initiation)
|
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)
Time Frame: At completion of professional involvement in intervention implementation (up to 7 months from first participant initiation)
|
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)
Time Frame: At completion of professional involvement in intervention implementation (up to 7 months from first participant initiation)
|
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
Time Frame: At completion of the intervention (up to 7 months from first participant initiation)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise self efficacy ( Exercise Self Efficacy Scale)
Time Frame: Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)
|
Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale, completed by young people with childhood-onset physical disability. The scale consists of 10 items assessing confidence in engaging in physical activity, with responses rated on a 4-point Likert scale (not at all true, rarely true, sometimes true, always true). Total scores range from 10 to 40, with higher scores indicating greater exercise self-efficacy. |
Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)
|
|
Mental health and well-being (Mental Health Continuum-Short Form)
Time Frame: Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)
|
Mental health and well-being will be assessed using the Mental Health Continuum-Short Form (MHC-SF), completed by young people with childhood-onset physical disability. The MHC-SF assesses emotional, social, and psychological well-being using a 6-point Likert scale (1 = everyday to 6 = never). Scores can be interpreted using continuous total and domain scores, with higher scores indicating greater well-being. Participants may also be classified as flourishing, moderately mentally healthy, or languishing based on established scoring criteria. |
Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202510045
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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