Physical DisabilityNCT07703306
Acceptability of FitSkills in the Irish Context for Young People With Childhood-onset Physical Disability
A study testing Gym based exercise in people with Physical Disability, run by Royal College of Surgeons, Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- Gym based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ailish Malone, PhD contact
About this study
Official title: 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.
- Conditions
- Physical Disability
- Being tested
- Gym based exercise
- Keywords
- physical activity, physical disability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gym based exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| FitSkills | Other | FitSkills- Community-based physical activity programme Receives: Other: Gym based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At completion of the intervention (up to 7 months from first participant initiation)
Secondary outcomes (2)
Exercise self efficacy ( Exercise Self Efficacy Scale)
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.
Measured: Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)
Mental health and well-being (Mental Health Continuum-Short Form)
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.
Measured: Baseline (prior to intervention initiation) and at 12 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703306
- Sponsor's protocol ID
- 202510045
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Sep;68(9):1195-1206. doi: 10.1111/dmcn.70209. Epub 2026 Feb 16.
PubMed 41699938Shields 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 Aug;48(17):5521-5536. doi: 10.1080/09638288.2026.2627626. Epub 2026 Feb 9.
PubMed 41660938Shields 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.
PubMed 37101339Shields 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.
PubMed 32641337Shields 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.
PubMed 33784487McKenzie 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.
PubMed 35694973Shields 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.
PubMed 40829864Shields 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.
PubMed 36101998
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of Translating FitSkills to the Irish Context to Facilitate Physical Activity Participation for Young People With Childhood-onset Physical Disability
- ClinicalTrials.gov ID
- NCT07703306
- Acronym / sponsor ID
- 202510045
- Conditions
- Physical Disability
- Keywords
- physical activity, physical disability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FitSkills | Other | Other: Gym based exerciseFitSkills- Community-based physical activity programme |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gym based exercise12 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 | Other | FitSkills |
Primary outcome
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.
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).
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Exercise self efficacy ( Exercise Self Efficacy Scale)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 41699938Brady 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 Sep;68(9):1195-1206. doi: 10.1111/dmcn.70209. Epub 2026 Feb 16.
- Background: PubMed 41660938Shields 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 Aug;48(17):5521-5536. doi: 10.1080/09638288.2026.2627626. Epub 2026 Feb 9.
- Background: PubMed 37101339Shields 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.
- Background: PubMed 32641337Shields 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.
- Background: PubMed 33784487Shields 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.
- Background: PubMed 35694973McKenzie 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.
- Background: PubMed 40829864Shields 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.
- Background: PubMed 36101998Shields 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ailish Malone, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Gym based exercise in people with Physical Disability, run by Royal College of Surgeons, Ireland.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ryan, PhD (014022413, jenniferryan@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (Reach) (time frame: Up to 6 months from study opening for recruitment). The study lists 9 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 NCT07703306, which also lists 8 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 14 Jul 2026.