A Co-designed Physical Activity Intervention in Fabry Disease

NCT ID: NCT06257901

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-30

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.

Conditions

Fabry Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adults with Fabry disease

Focus groups and participatory workshops

Interviews/Focus groups/Participatory workshops

Intervention Type: OTHER

Qualitative study (no intervention delivered)

Lay specialist stakeholders

Focus groups

Interviews/Focus groups/Participatory workshops

Intervention Type: OTHER

Qualitative study (no intervention delivered)

Specialist stakeholders

Interviews

Interviews/Focus groups/Participatory workshops

Intervention Type: OTHER

Qualitative study (no intervention delivered)

Interventions

Interviews/Focus groups/Participatory workshops

Qualitative study (no intervention delivered)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have been diagnosed with Fabry disease.
• Aged ≥ 18 years old.
• Able to independently ambulate with or without the use of a walking aid.
• Lives in the United Kingdom.
• Deemed eligible to participate following screening by a clinician (for participatory workshops).

The circumstances in which an individual may be deemed ineligible to participate in the participatory workshops based on the clinician's assessment are as follows:

• Severe neuropathic pain.
• Stage 4 heart failure or other condition resulting in breathlessness to a level they cannot participate.
• Other clinical condition which dominates the clinical picture to the extent that it dominates the symptoms and biases the results.

Exclusion Criteria

• Incapacity to provide written informed consent.
• Unable to communicate in English to a sufficient level to permit engagement in the study.

Specialist stakeholders will be members of staff at NHS specialist centres for Fabry disease who are directly involved in the healthcare of adults with Fabry disease.

Lay specialist stakeholders will be individuals who have been involved in supporting adults with Fabry disease, such as family, friends and members of staff at the Society for Mucopolysaccharide Diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Brunel University

OTHER

Sponsor Role: lead

Responsible Party

Dr Daniel Bailey

Senior Lecturer in Sport, Health and Exercise Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brunel University London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

45091-NHS-Oct/2023- 47368-1

Identifier Type: -

Identifier Source: org_study_id