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

NCT07495410 | Enrolling By Invitation

• 1 other identifier: A-FAD-FIT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fabry Disease

Keywords

Fabry disease; Anderson-Fabry disease; physiotherapy; exercise; exercise training; rehabilitation; physical activity; quality of life; functional capacity; muscle strength

Outcome Measures

Primary Outcomes (1)

• Change in cardiorespiratory fitness

  Change in cardiorespiratory fitness assessed by ergospirometry before and after the 12-week targeted physiotherapy intervention.

  Baseline and after 12 weeks

Secondary Outcomes (8)

• Change in muscle strength

  Baseline and after 12 weeks

• Change in functional capacity measured by the 6-minute walk test

  Baseline and after 12 weeks

• Change in functional performance measured by the 30-second chair stand test

  Baseline and after 12 weeks

• Change in respiratory function

  Baseline and after 12 weeks

• Change in health-related quality of life

  Baseline and after 12 weeks

Study Arms (1)

Physiotherapy intervention

EXPERIMENTAL

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

Interventions

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.

Physiotherapy intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, 19800, Czechia

Location

MeSH Terms

Conditions

Fabry Disease; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters degree

Model Details: All enrolled participants will receive the same 12-week exercise intervention. Outcomes will be assessed before and after the intervention.

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 27, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CZ (1)