A Co-designed Physical Activity Intervention in Fabry Disease

February 5, 2024 updated by: Dr Daniel Bailey, Brunel University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults with Fabry disease, lay specialist stakeholders and specialist stakeholders who meet the eligibility criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with Fabry disease
Focus groups and participatory workshops
Other: Interviews/Focus groups/Participatory workshops
Qualitative study (no intervention delivered)
Lay specialist stakeholders
Focus groups
Other: Interviews/Focus groups/Participatory workshops
Qualitative study (no intervention delivered)
Specialist stakeholders
Interviews
Other: Interviews/Focus groups/Participatory workshops
Qualitative study (no intervention delivered)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus groups (adults with Fabry disease)
Time Frame: 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).
9 months
Focus groups (lay specialist stakeholders)
Time Frame: 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).
9 months
Semi-structured interviews (specialist stakeholders)
Time Frame: 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).
9 months
Participatory workshops (adults with Fabry disease)
Time Frame: 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).
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brunel University

Collaborators

Royal Free Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45091-NHS-Oct/2023- 47368-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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