Fabry DiseaseA-FAD-FITNCT07495410
Anderson-Fabry Disease Fitness Improvement Training
A study testing Physiotherapy exercise programe in people with Fabry Disease, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fabry Disease
- What is being tested?
- Physiotherapy exercise programe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Oct 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital
Prague, 12808
Jan Vávra, Masters, +420601200272, vavrajan1@gmail.com
Vladimír Tuka, doc, Vladimir.Tuka@vfn.cz
About this study
Official title: Anderson-Fabry Disease Fitness Improvement Training: A-FAD-FIT
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.
Read the detailed description
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.
- Conditions
- Fabry Disease
- Being tested
- Physiotherapy exercise programe
- Keywords
- Fabry disease, Anderson-Fabry disease, physiotherapy, exercise, exercise training, rehabilitation, physical activity, quality of life, functional capacity, muscle strength
- Medical subject headings
- Fabry Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy exercise programeBehavioural
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 group | Role | What they receive |
|---|---|---|
| Exercise Intervention Group | Experimental | 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. Receives: Behavioral: Physiotherapy exercise programe |
| Control Group | No intervention | Participants will receive no study-specific exercise intervention. They will be assessed at baseline and 12 months after baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks after baseline
Secondary outcomes (22)
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.
Measured: Baseline and 12 months after baseline
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.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
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.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
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.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in forced expiratory volume in 1 second (FEV1)
Change in forced expiratory volume in 1 second (FEV1), expressed in liters, assessed by pulmonary function testing. In the intervention group, FEV1 will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, FEV1 will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in vital capacity (VC)
Change in vital capacity (VC), expressed in liters, assessed by pulmonary function testing. In the intervention group, VC will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, VC will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in diffusing capacity of the lungs for carbon monoxide (DLCO)
Change in diffusing capacity of the lungs for carbon monoxide (DLCO), expressed in mmol/min/kPa, assessed by pulmonary function testing. In the intervention group, DLCO will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, DLCO will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in Hospital Anxiety and Depression Scale - Anxiety subscale score
Change in anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The subscale consists of 7 items scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in Hospital Anxiety and Depression Scale - Depression subscale score
Change in depressive symptoms assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS). The subscale consists of 7 items scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Physical Functioning domain score
Change in physical functioning assessed using the Physical Functioning domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 10 items and is scored from 0 to 100, with higher scores indicating better physical functioning. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Role Physical domain score
Change in limitations in usual role activities due to physical health problems assessed using the Role Physical domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 4 items and is scored from 0 to 100, with higher scores indicating fewer limitations due to physical health problems. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Bodily Pain domain score
Change in bodily pain assessed using the Bodily Pain domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 2 items and is scored from 0 to 100, with higher scores indicating less pain and less interference of pain with usual activities. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 General Health domain score
Change in general health perceptions assessed using the General Health domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 5 items and is scored from 0 to 100, with higher scores indicating better perceived general health. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Vitality domain score
Change in vitality assessed using the Vitality domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 4 items and is scored from 0 to 100, with higher scores indicating greater vitality and lower levels of fatigue. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Social Functioning domain score
Change in social functioning assessed using the Social Functioning domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 2 items and is scored from 0 to 100, with higher scores indicating better social functioning and less interference of health problems with social activities. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Role Emotional domain score
Change in limitations in usual role activities due to emotional problems assessed using the Role Emotional domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 3 items and is scored from 0 to 100, with higher scores indicating fewer role limitations due to emotional problems. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Mental Health domain score
Change in mental health assessed using the Mental Health domain of the 36-Item Short Form Health Survey (SF-36). The domain consists of 5 items and is scored from 0 to 100, with higher scores indicating better mental health and psychological well-being. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in EQ-5D-5L health state index value
Change in health-related quality of life assessed using the EQ-5D-5L descriptive system. The instrument assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity. Responses will be converted to an EQ-5D-5L health state index value using an appropriate validated value set. Higher index values indicate better health-related quality of life. In the intervention group, the index value will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the index value will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in EQ-5D-5L Visual Analogue Scale score
Change in self-rated health assessed using the EQ-5D-5L Visual Analogue Scale (EQ VAS). The scale ranges from 0 to 100, where 0 represents the worst health the participant can imagine and 100 represents the best health the participant can imagine. Higher scores indicate better self-rated health. In the intervention group, the score will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, the score will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in skeletal muscle mass
Change in skeletal muscle mass, expressed in kilograms, assessed by bioelectrical impedance analysis using the InBody970 device. In the intervention group, skeletal muscle mass will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, skeletal muscle mass will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in body fat mass
Change in body fat mass, expressed in kilograms, assessed by bioelectrical impedance analysis using the InBody970 device. In the intervention group, body fat mass will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, body fat mass will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in whole-body phase angle
Change in whole-body phase angle, expressed in degrees, assessed at 50 kHz by bioelectrical impedance analysis using the InBody970 device. In the intervention group, whole-body phase angle will be assessed at baseline, immediately after the 12-week exercise intervention, and 12 months after baseline. In the control group, whole-body phase angle will be assessed at baseline and 12 months after baseline.
Measured: Baseline, 12 weeks after baseline, and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 Oct 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be non-randomly assigned to either a 12-week exercise intervention group or a control group receiving no study-specific exercise intervention. Group assignment will primarily be based on participants' willingness to participate in the exercise programme and logistical feasibility, particularly the ability to attend regular supervised exercise sessions. 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Vávra, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495410
- Sponsor's protocol ID
- A-FAD-FIT
- Acronym
- A-FAD-FIT
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data. Any future data sharing would require separate consideration in accordance with applicable ethics, participant consent, and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anderson-Fabry Disease Fitness Improvement Training: A-FAD-FIT
- ClinicalTrials.gov ID
- NCT07495410
- Acronym / sponsor ID
- A-FAD-FIT / A-FAD-FIT
- Conditions
- Fabry Disease
- Keywords
- Fabry disease, Anderson-Fabry disease, physiotherapy, exercise, exercise training, rehabilitation, physical activity, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be non-randomly assigned to either a 12-week exercise intervention group or a control group receiving no study-specific exercise intervention. Group assignment will primarily be based on participants' willingness to participate in the exercise programme and logistical feasibility, particularly the ability to attend regular supervised exercise sessions. 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Behavioral: Physiotherapy exercise programeParticipants 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. |
| Control Group | No intervention | –Participants will receive no study-specific exercise intervention. They will be assessed at baseline and 12 months after baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy exercise programeA 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. | Behavioural | Exercise Intervention Group |
Primary outcome
Change from baseline in peak oxygen uptake (VO2peak) after 12 weeks
Time frame: Baseline and 12 weeks after baseline
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.
22 secondary outcomes
Change from baseline in peak oxygen uptake (VO2peak) at 12 months
Time frame: Baseline and 12 months after baseline
Change in handgrip strength
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in 6-minute walk distance
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in 30-second chair stand test performance
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in vital capacity (VC)
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in Hospital Anxiety and Depression Scale - Anxiety subscale score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in Hospital Anxiety and Depression Scale - Depression subscale score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Physical Functioning domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Role Physical domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Bodily Pain domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 General Health domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Vitality domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Social Functioning domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Role Emotional domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in SF-36 Mental Health domain score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in EQ-5D-5L health state index value
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in EQ-5D-5L Visual Analogue Scale score
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in skeletal muscle mass
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in body fat mass
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Change in whole-body phase angle
Time frame: Baseline, 12 weeks after baseline, and 12 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data. Any future data sharing would require separate consideration in accordance with applicable ethics, participant consent, and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy exercise programe in people with Fabry Disease, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Vávra, Masters (+420601200272, Jan.Vavra2@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in peak oxygen uptake (VO2peak) after 12 weeks (time frame: Baseline and 12 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.