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Enrolling by invitation NCT07495410

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

No phase Interventional Fabry Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physiotherapy exercise programe.
Who it may be relevant to
Registry conditions: Fabry Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Change in cardiorespiratory fitness [Time frame: Baseline and after 12 weeks]
Secondary outcome measures (8)
  • Change in muscle strength [Time frame: 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 functional performance measured by the 30-second chair stand test [Time frame: Baseline and after 12 weeks]
  • Change in respiratory function [Time frame: Baseline and after 12 weeks]
  • Change in health-related quality of life [Time frame: Baseline and after 12 weeks]
  • Change in anxiety and depressive symptoms [Time frame: Baseline and after 12 weeks]
  • Change in self-reported physical activity [Time frame: Baseline and after 12 weeks]
  • Change in body composition [Time frame: Baseline and after 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • General University Hospital — Prague

Identifiers

NCT: NCT07495410 · A-FAD-FIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗