ClinicalTrials.gov record NCT07495410

Anderson-Fabry Disease Fitness Improvement Training

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationCzechia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study tests a 12-week physiotherapy-led exercise programme in people with Fabry disease. Participants are non-randomly assigned to the exercise programme (one supervised session weekly plus two home sessions weekly and step-count increase) or to a control group with no study-specific exercise. The exercise group is assessed at baseline, after 12 weeks, and at 12 months; the control group is assessed at baseline and 12 months.

What it is studying. The study is testing whether a 12-week physiotherapy-led exercise programme changes cardiorespiratory fitness, muscle strength, physical function, and health-related quality of life in people with Fabry disease.

What the researchers hope to learn. The study aims to evaluate functional and cardiorespiratory capacity and to investigate the effects of a 12-week physiotherapy-led exercise programme in Fabry disease. The primary scientific outcome is change in peak oxygen uptake (VO2peak) after 12 weeks. Secondary goals include measuring changes in handgrip strength, 6-minute walk distance, pulmonary function (FEV1, VC, DLCO), physical performance tests, multiple domains of the SF-36 and EQ-5D-5L health measures, anxiety and depression scores, and body composition (skeletal muscle and fat mass, phase angle).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study will evaluate physical function, cardiorespiratory fitness, muscle strength, and quality of life in patients with Fabry disease and assess the effects of a 12-week physiotherapy-led exercise programme. Participants will be non-randomly assigned to an exercise intervention group or a control group receiving no study-specific exercise intervention. The intervention group will be assessed at baseline, immediately after the 12-week intervention, and 12 months after baseline. The control group will be assessed at baseline and 12 months after baseline.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Physiotherapy exercise programe

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Confirmed diagnosis of Fabry disease
  • Age 18 years or older
  • Followed at a participating clinical center
  • Able to understand the study procedures and provide informed consent
  • Clinically stable and medically suitable for exercise testing and participation in the exercise programme

Exclusion criteria

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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 structured physiotherapy and exercise interventions in this population remains limited. The aim of this study is to evaluate functional and cardiorespiratory capacity in patients with Fabry disease and to investigate the effects of a 12-week physiotherapy-led exercise programme. Participants will be non-randomly assigned to either an exercise intervention group or a control group receiving no study-specific exercise intervention. Group assignment will primarily reflect participants' willingness to participate in the exercise programme and logistical feasibility, particularly the ability to attend regular supervised exercise sessions. Participants in the intervention group will complete a 12-week physiotherapy-led programme consisting of one supervised exercise session per week and two home-based exercise sessions per week. Supervised sessions include a brief aerobic warm-up followed by strengthening exercises using body weight and resistance bands. The programme also includes a progressive increase in daily ambulatory physical activity, monitored primarily by daily step count. Participants in the intervention group will be assessed at baseline, immediately after the 12-week intervention, and 12 months after baseline. Participants in the control group will receive no study-specific exercise intervention and will be assessed at baseline and 12 months after baseline. The study will evaluate short-term changes following the exercise intervention as well as longer-term changes in the main study outcomes.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are assigned non-randomly to either a 12‑week physiotherapy-led exercise programme or to a control group that receives no study-specific exercise. The exercise programme involves one supervised session per week and two home-based sessions per week, with a brief aerobic warm-up, strengthening using body weight and resistance bands, and a progressive increase in daily step count; adherence is monitored with exercise diaries and during supervised sessions. Study assessments include cardiopulmonary exercise testing (CPET) to measure peak oxygen uptake (VO2peak), the 6-minute walk test, handgrip strength, the 30-second chair stand, pulmonary function tests (FEV1, vital capacity, DLCO), health and quality-of-life questionnaires (Hospital Anxiety and Depression Scale, SF-36, EQ-5D-5L), and body composition by bioelectrical impedance analysis (InBody970). Intervention participants are assessed at baseline, immediately after the 12-week programme, and at 12 months; control participants are assessed at baseline and at 12 months.

How the study is structured. This is an interventional, non-randomized parallel study with no masking. Participants are placed into either an Exercise Intervention Group (12-week physiotherapy-led programme with one supervised session per week, two home sessions per week, and a progressive increase in daily step count) or a Control Group (no study-specific exercise). Assessments occur at baseline, immediately after the 12-week programme (exercise group only), and at 12 months for both groups. Group assignment reflects participants' willingness and logistical ability to attend supervised sessions.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Czechia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Fabry disease

Clinical trials47 trials listed for Fabry diseaseEvery trial the registry lists for Fabry disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Fabry disease researchLatest monthly update: September 2026. Includes: SGLT2 outcome link. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 6, 2025
Primary completion
Mar 31, 2028 (estimated)
Study completion
Dec 31, 2028 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Sep 21, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
General University Hospital, Prague
Principal investigator
Jan Vávra, Principal Investigator
General University Hospital, Prague

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

randomly assigned
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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