A Co-designed Physical Activity Intervention in Fabry Disease

Fabry Disease Clinical Trial

Official title:

Co-design of a Physical Activity and Sedentary Behaviour Intervention for Adults With Fabry Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257901
• Other study ID #: 45091-NHS-Oct/2023- 47368-1
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Brunel University
• Contact: Daniel Bailey
• Phone: 01895265363
• Email: daniel.bailey[@]brunel.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Individuals with Fabry disease will be eligible to participate in the study if they meet the following 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 for all participants will be as follows:

• 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.

Related Conditions & MeSH terms

• Fabry Disease

Intervention

Other:
• Interviews/Focus groups/Participatory workshops
Qualitative study (no intervention delivered)

Locations

Country	Name	City	State
United Kingdom	Brunel University London	London

Sponsors (2)

Lead Sponsor	Collaborator
Brunel University	Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focus groups (adults with Fabry disease)	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).	9 months
Primary	Focus groups (lay specialist stakeholders)	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).	9 months
Primary	Semi-structured interviews (specialist stakeholders)	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).	9 months
Primary	Participatory workshops (adults with Fabry disease)	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).	9 months