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Enrolling by Invitation

NCT Number: NCT07495410

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

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.

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Key information

Conditions

Fabry Disease Behavior Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Motor Activity Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General University Hospital

Prague, 19800, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy exercise programe

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change in respiratory function

    Time frame: Baseline and after 12 weeks

    Change in respiratory function assessed by body plethysmography before and after the intervention.

  5. 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.

  6. 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.

  7. 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.

  8. Change in body composition

    Time frame: Baseline and after 12 weeks

    Change in body composition assessed by InBody analysis before and after the intervention.

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Acronym: A-FAD-FIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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