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

10 de julio de 2026 actualizado por: Royal College of Surgeons, Ireland

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

25

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Ailish Malone, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant recruitment (Reach)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Exercise self efficacy ( Exercise Self Efficacy Scale)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de julio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 202510045

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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