Anderson-Fabry Disease Fitness Improvement Training
ConditionFabry Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral University Hospital, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physiotherapy exercise programe
BehavioralA 12-week physiotherapy-led exercise programme consisting of one supervised session 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. Adherence is monitored using exercise diaries and regular follow-up during supervised sessions.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Exercise Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in peak oxygen uptake (VO2peak) after 12 weeks
Change from baseline in peak oxygen uptake (VO2peak), expressed in mL/kg/min, assessed during cardiopulmonary exercise testing (CPET) in the exercise intervention group following the 12-week exercise programme.
Time frame
Baseline and 12 weeks after baselineSecondary outcomes
1
Change from baseline in peak oxygen uptake (VO2peak) at 12 months
Change from baseline in peak oxygen uptake (VO2peak), expressed in mL/kg/min, assessed during cardiopulmonary exercise testing (CPET). VO2peak will be assessed at baseline and 12 months after baseline in both the exercise intervention and control groups. The change over 12 months will be compared between groups.
Time frame
Baseline and 12 months after baseline2
Change in handgrip strength
Change in handgrip strength, expressed in kilograms, assessed using handgrip dynamometry. Participants will be assessed in a seated position with the arm close to the body and the elbow flexed at approximately 90 degrees. Three maximal trials will be performed for each hand. The highest value from each hand will be retained, and the mean of the highest right- and left-hand values will be used as the handgrip strength outcome. In the intervention group, handgrip strength will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, handgrip strength will be assessed at baseline and 12 months after baseline.
Time frame
Baseline, 12 weeks after baseline, and 12 months after baseline3
Change in 6-minute walk distance
Change in distance walked during the 6-minute walk test, expressed in meters. In the intervention group, the 6-minute walk distance will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the 6-minute walk distance will be assessed at baseline and 12 months after baseline.
Time frame
Baseline, 12 weeks after baseline, and 12 months after baseline4
Change in 30-second chair stand test performance
Change in the number of completed stands during the 30-second chair stand test. In the intervention group, performance will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, performance will be assessed at baseline and 12 months after baseline.
Time frame
Baseline, 12 weeks after baseline, and 12 months after baselineSponsors and contacts
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Source ClinicalTrials.gov