Anderson-Fabry Disease Fitness Improvement Training: A-FAD-FIT (A-FAD-FIT)

March 21, 2026 updated by: Jan Vávra, General University Hospital, Prague
This study will evaluate whether a 12-week physiotherapy and exercise program can improve physical function and quality of life in patients with Anderson-Fabry disease. Participants will complete assessments before and after the program. The intervention includes regular exercise sessions using body weight, resistance bands, and gradual increases in daily physical activity. The study is intended to determine whether a structured physiotherapy program is feasible and potentially beneficial for people living with Anderson-Fabry disease.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Anderson-Fabry disease is a rare X-linked lysosomal storage disorder associated with multisystem involvement, reduced exercise tolerance, fatigue, pain, and impaired quality of life. Evidence regarding the effects of structured physiotherapy and exercise interventions in this patient population remains limited.

The aim of this study is to evaluate the feasibility and potential clinical benefit of a 12-week targeted physiotherapy intervention in patients with Anderson-Fabry disease. Participants will undergo baseline and post-intervention assessment focused on physical fitness, functional performance, and patient-reported outcomes.

The intervention will consist of 45-minute exercise sessions performed three times per week over 12 weeks. The program will combine aerobic and strengthening exercise using body weight and resistance bands and will include a gradual increase in daily step count. Adherence to the intervention will be monitored throughout the study.

The study is intended to assess whether a structured physiotherapy program may improve physical function and quality of life in patients with Anderson-Fabry disease and to provide data to support future rehabilitation recommendations in this population.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Czechia
      • Prague, Czechia, 19800
        • General University Hospital

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

No

Description

Inclusion Criteria:

  • Diagnosis of Anderson-Fabry disease
  • Age 18 years or older
  • Followed at a participating clinical center
  • Able to understand study procedures and provide informed consent
  • Clinically stable and considered suitable for participation in a physiotherapy and exercise program

Exclusion Criteria:

  • Acute deterioration in health status at the time of enrollment
  • Medical contraindication to exercise testing or participation in the exercise program
  • Severe comorbidity preventing safe participation in the intervention
  • Inability to comply with the study procedures or complete follow-up assessments

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy intervention
Participants will receive a 12-week targeted physiotherapy and exercise intervention consisting of 45-minute sessions performed three times per week and increasing number of daily steps. The program combines aerobic and strengthening exercise, including body weight exercises, resistance band training, and a gradual increase in daily step count.
Behavioral: Physiotherapy exercise programe
A 12-week physiotherapy and exercise program consisting of 45-minute sessions performed three times per week and gradual increase in daily step count by approximately 10 percent every 2 weeks. The intervention combines aerobic and strengthening components, including body weight exercises and resistance band training, together with counting of daily steps. Adherence is monitored using exercise diaries and regular follow-up during therapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiorespiratory fitness
Time Frame: Baseline and after 12 weeks
Change in cardiorespiratory fitness assessed by ergospirometry before and after the 12-week targeted physiotherapy intervention.
Baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle strength
Time Frame: Baseline and after 12 weeks
Change in muscle strength assessed by hand grip strength testing before and after the intervention.
Baseline and after 12 weeks
Change in functional capacity measured by the 6-minute walk test
Time Frame: Baseline and after 12 weeks
Change in walking capacity assessed by the 6-minute walk test before and after the intervention.
Baseline and after 12 weeks
Change in functional performance measured by the 30-second chair stand test
Time Frame: Baseline and after 12 weeks
Change in lower-extremity functional performance assessed by the 30-second chair stand test before and after the intervention.
Baseline and after 12 weeks
Change in respiratory function
Time Frame: Baseline and after 12 weeks
Change in respiratory function assessed by body plethysmography before and after the intervention.
Baseline and after 12 weeks
Change in health-related quality of life
Time Frame: Baseline and after 12 weeks
Change in health-related quality of life assessed by the SF-36 questionnaire before and after the intervention.
Baseline and after 12 weeks
Change in anxiety and depressive symptoms
Time Frame: Baseline and after 12 weeks
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) before and after the intervention.
Baseline and after 12 weeks
Change in self-reported physical activity
Time Frame: Baseline and after 12 weeks
Change in self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ)-based questionnaire before and after the intervention.
Baseline and after 12 weeks
Change in body composition
Time Frame: Baseline and after 12 weeks
Change in body composition assessed by InBody analysis before and after the intervention.
Baseline and after 12 weeks

Collaborators and Investigators

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

Sponsor

General University Hospital, Prague

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 (Actual)

October 6, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

March 21, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-FAD-FIT

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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