A Co-designed Physical Activity Intervention in Fabry Disease

Completed

• Conditions: Fabry Disease
• Interventions: Other: Interviews/Focus groups/Participatory workshops

• Registration Number: NCT06257901
• Lead Sponsor: Brunel University

Brief Summary

Currently, treatments for Fabry disease are pharmacological and predominantly focus on the physical symptoms of the disease. In the general population and individuals with disabilities, increasing physical activity levels and reducing sedentary time can be an effective, non-pharmacological treatment to improve mental health and quality of life. Such interventions have not yet been developed or evaluated in people with Fabry disease.

The aim of this study is to co-design a physical activity and sedentary behaviour intervention tailored to the needs of adults with Fabry disease. The study will seek to gain the expertise of adults with Fabry disease, specialist stakeholders (physicians, cardiologists and clinical nurse specialists) and lay specialist stakeholders (family and friends of adults with Fabry disease and members of staff and volunteers at the Society for Mucopolysaccharide Diseases). A range of views and experiences of physical activity and sedentary behaviour will be explored via focus groups (with individuals with Fabry disease and lay specialist stakeholders) and semi-structured interviews (with specialist stakeholders). The information gathered from the focus groups and interviews will then be utilised to inform participatory workshops (with individuals with Fabry disease) to test intervention concepts. Data from these activities will inform the design of a future intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Study Start: 2024-03-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with Fabry disease	Interviews/Focus groups/Participatory workshops	Focus groups and participatory workshops
Lay specialist stakeholders	Interviews/Focus groups/Participatory workshops	Focus groups
Specialist stakeholders	Interviews/Focus groups/Participatory workshops	Interviews

Primary Outcome Measures

Name	Time	Method
Focus groups (adults with Fabry disease)	9 months	Themes describing adults with Fabry disease's views and experiences of physical activity and sedentary behaviour- Emergence of themes describing participants' views and experiences from analysis of focus groups (using the Framework Method).
Semi-structured interviews (specialist stakeholders)	9 months	Themes describing specialist stakeholders' views and experiences of physical activity and sedentary behaviour- Emergence of themes describing participants' views and experiences from analysis of interviews (using the Framework Method).
Participatory workshops (adults with Fabry disease)	9 months	Themes describing adults with Fabry disease's views and experiences of initial intervention concepts- Emergence of themes describing participants' views and experiences from analysis of participatory workshops (using the Framework Method).
Focus groups (lay specialist stakeholders)	9 months	Themes describing lay specialist stakeholders' views and experiences of physical activity and sedentary behaviour- Emergence of themes describing participants' views and experiences from analysis of focus groups (using the Framework Method).

Trial Locations

Locations (1)

Brunel University London; 🇬🇧 London, United Kingdom