Anderson-Fabry Disease Fitness Improvement Training

Sponsor
General University Hospital, Prague
Study ID
NCT07495410
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physiotherapy exercise programe — BEHAVIORAL
    A 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.

Study Details

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.

Key Dates

First listed
Mar 27, 2026
Start date
Oct 6, 2025
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exercise Intervention Group
    Participants will complete a 12-week physiotherapy-led exercise programme consisting of one supervised exercise session per week and two home-based exercise sessions per week, together with a progressive increase in daily step count. Supervised sessions include a brief aerobic warm-up followed by strengthening exercises using body weight and resistance bands. Participants will be assessed at baseline, immediately after the 12-week intervention, and 12 months after baseline.
  • No Intervention: Control Group
    Participants will receive no study-specific exercise intervention. They will be assessed at baseline and 12 months after baseline.

Primary Outcome Measure

Change from baseline in peak oxygen uptake (VO2peak) after 12 weeks [ Time Frame: Baseline and 12 weeks after baseline ]

Central Contacts

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