The ACTIVE-FAB study.
Research type
Research Study
Full title
The ACTIVE-FAB intervention to reduce sedentary behaviour and increase physical activity in adults with Fabry disease: a randomised controlled feasibility trial.
IRAS ID
340412
Contact name
Daniel Bailey
Contact email
Sponsor organisation
Brunel University London
Duration of Study in the UK
0 years, 6 months, 30 days
Research 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, reducing sedentary behaviour and increasing physical activity 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.
We have designed a new sedentary behaviour and physical activity intervention with patients and healthcare professionals to support adults with Fabry disease improve their physical health, mental health, and quality of life. The purpose of this study is to test this new intervention, called ACTIVE-FAB, to see if it is acceptable and safe for adults with Fabry disease and what their experiences are when taking part in it. To do this, 45 adults with Fabry disease will be recruited and randomly allocated to the intervention group or the control group (continue with usual care and receive a general healthy lifestyle leaflet) for 3 months. Participants receiving the intervention will get (1) an initial consultation with a physiotherapist to discuss baseline sedentary behaviour and physical activity, and set goals, (2) two progress consultations with a physiotherapist to discuss engagement with the intervention, and review sedentary behaviour and physical activity goals, (3) an educational website covering the importance of limiting sedentary behaviour and engaging in physical activity, (4) a smartwatch that tracks sedentary behaviour and physical activity, and (5) an optional peer support group. All participants in the intervention and control groups will complete mental health and quality of life questionnaires. They will also have sedentary behaviour and physical activity measured using an activity monitor (called an activPAL) worn on the thigh for 8 days. They will complete these measures at baseline and 3 months after randomisation. We will assess if it is possible to deliver the intervention by seeing how long it takes to recruit enough participants to take part in the study, how many complete it and how many provide information on each of the measures we take. We will also talk to participants to see if they found the intervention and the information we are collecting are acceptable.REC name
East of Scotland Research Ethics Service REC 1
REC reference
25/ES/0009
Date of REC Opinion
7 Mar 2025
REC opinion
Further Information Favourable Opinion