ClinicalTrials.gg
Not yet recruitingNCT07703306Updated Jul 14, 2026

Acceptability of FitSkills in the Irish Context for Young People With Childhood-onset Physical Disability

An interventional study of Gym based exercise in Physical Disability, sponsored by Royal College of Surgeons, Ireland. Not yet recruiting. Open to participants aged 13 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
13 Years to 24 Years
Sex
All
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Study 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.

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Conditions studied

  • Physical Disability

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Keywords

  • physical activity
  • physical disability
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 25 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    FitSkills

    FitSkills- Community-based physical activity programme

    Other: Gym based exercise

Interventions

  • OtherGym based exercise

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months from study opening for recruitment

  2. 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).

    Time frame: Up to 7 months from first participant initiation of the intervention

  3. 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.

    Time frame: Up to 7 months from first participant initiation of the intervention

  4. 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.

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

  5. 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.

    Time frame: Up to 7 months from first participant initiation of the intervention

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 41699938 ↗
  • 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. PubMed 41660938 ↗
  • 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. PubMed 37101339 ↗
  • 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. PubMed 32641337 ↗
  • 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. PubMed 33784487 ↗
  • 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. PubMed 35694973 ↗
  • 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. PubMed 40829864 ↗
  • 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. PubMed 36101998 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 6 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2026
First posted
Jul 14, 2026
StartEst.
Jul 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07703306
Lead sponsor
Royal College of Surgeons, Ireland
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 14, 2026

Study contacts

Jennifer Ryan, PhD
Contact
jenniferryan@rcsi.com
014022413
Ailish Malone, PhD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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