FSHDGRIPonFSHDNCT06712043
Testing a Tailored Home Exercise Program to Reduce Pain and Fatigue in Patients with FSHD.
A study testing Personalised Exercise in people with FSHD, run by Radboud University Medical Center.
Trial summary
The goal of this intervention study is to determine the effect of a tailored exercise program (with aerobic, strength and balance training) in patients with FSHD. The main aim is to determine the effect of the exercise program on pain and fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FSHD
- What is being tested?
- Personalised Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jul 2025
- 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
- Age >18 years
- Verified diagnosis of FSHD type 1, based on the clinical criteria established by Padberg et al. (1991) (22).
- Category A or B of the four clinical categories according to the Comprehensive Clinical Evaluation Form (23), these patients have the most peculiar signs of the disease
- A CIS-fatigue score of ≥ 35
- Owning of and being able to use a smartphone
- Preserved ability to ambulate at the time of the selection
Show all 9Show fewer
- No pulmonary or cardiological involvement, that could interfere with physical training.
- Absence of central or peripheral nervous system involvement as from neurological history and physical assessment
- Absence of limb contractures and tendon retractions
Who cannot join
- Use of beta-blocker medication
- Presence of additional diseases likely to interfere with the measurements
- Psychological-psychiatric disorders
- A musculoskeletal injury that impairs exercising
- Scoliosis that impairs training
- Recent adjustment of any medications or medications that may impact fatigue or taking stimulants for fatigue (e.g., Modafinil, amantadine)
Show all 10Show fewer
- Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study
- Pregnant women
- Patient incapable of understanding the purpose and conditions of the study, incapable of giving consent or using the app
- Patient deprived of liberty or patient under guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Testing a Tailored Home Exercise Program to Gain Insight Into Performance Fatigability and Reduce Pain and Fatigue in Patients with FSHD: the GRIP on FSHD Study
The goal of this intervention study is to determine the effect of a tailored exercise program (with aerobic, strength and balance training) in patients with FSHD.
The main aim is to determine the effect of the exercise program on pain and fatigue.
Participants will follow a 16 week training program with tailored exercises. The exercises will be prescribed via the app 'Physitrack'. After 16 weeks, the effect on pain, fatigue, fatigability, aerobic capacity, balance, physical function, sleep and the ability to participate in social activities will be determined.
Read the detailed description
Rationale: Pain and fatigue are two common and disabling symptoms in FSHD. No studies in FSHD have proven to reduce pain yet. (Aerobic) exercise has proven to reduce fatigue, however, current training guidelines are generic which can lead to overuse of injuries. The investigators expect that a personalized training program with aerobic exercise but also strength and balance training, that is adapted to a participants symptoms and wishes will provide a positive effect on pain and fatigue.
Objectives:
Primary objectives
- To determine the effect of a tailored exercise program by using the widely implemented exercise app "Physitrack" on experienced pain and fatigue in patients with FSHD.
- To investigate the relationship between perceived pain and fatigue and performance fatigability, disease severity, clinical phenotype, and level of activity in patients with FSHD Secondary objectives
- To determine the responsiveness of the performance fatigability test. 2. To investigate the influence of a decreasing performance fatigability on experienced fatigue 3. To provide input for new training guidelines for people with FSHD. Study design: Single group intervention study with historical control group. Study population: 50 individuals with FSHD >18 years Intervention: An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Main study parameters/endpoints:
The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale and the average daily pain score during 2 weeks are the primary endpoints.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this study includes: (1) two visits to the Radboudumc (approximately 3-4 hours, including a break) with physical test and questionnaires, (2) following a 16 week personalized exercise program, including filling in questionnaires about pain and fatigue and (3) wearing an activity tracker for 1 week before and after the study. Participants will have a weekly phone call with the researcher, and when participants will have complaints such as pain and/or fatigue, the training will be adapted. Therefore, the investigators expect that the risk will be minimal, and patient might experience the benefits of personalized training.
- Conditions
- FSHD
- Being tested
- Personalised Exercise, Historical control group
- Keywords
- Personalized exercise, Rehabilitation, Aerobic exercise, Strength training, Balance training, Fatigue, Pain, Fatigability, Smartphone application
- Medical subject headings
- Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised ExerciseBehavioural
An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Historical control groupBehavioural
Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app. Receives: Behavioral: Personalised Exercise |
| Historical control group | Active comparator | Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD) Receives: Behavioral: Historical control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily observed pain
Daily observed pain during a period of 2 weeks, measured with the Visual Analog Scale (VAS)
Measured: 16 weeks
Fatigue
The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale.
Measured: 16 weeks
Secondary outcomes (12)
Performance fatigability
The quadriceps isometric intermittent fatigue test (QIF test)
Measured: 16 weeks
Fatigue (VAS)
VAS fatigue
Measured: 16 weeks
Aerobic capacity
B-FIT Exercise test
Measured: 16 weeks
Long function
Maximal expiratory pressure (MEP)
Measured: 16 weeks
Long function
Forced vital capacity (FVC)
Measured: 16 weeks
Long function
Maximal inspiratory pressure (MIP)
Measured: 16 weeks
Balance
Mini Balance Evaluation Systems Test (Mini-BESTest)
Measured: 16 weeks
Pain Questionnaire
Brief pain inventory questionnaire
Measured: 16 weeks
Sleep
PROMIS Short Form v1.0 - Sleep Disturbance 8a
Measured: 16 weeks
Social roles an participation
PROMIS Short Form v2.0 - Ability to Participate in Social Roles and Activities 8a
Measured: 16 weeks
Physical Function
PROMIS Short Form v2.0 - Physical Function 20a.
Measured: 16 weeks
Physical activity
Activity tracker
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study startFeb 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FSHDStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Single group intervention study with historical control group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712043
- Sponsor's protocol ID
- NL86789.091.24
- Acronym
- GRIPonFSHD
- Status last verified
- Nov 2024
- First submitted
- 13 Aug 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Tailored Home Exercise Program to Gain Insight Into Performance Fatigability and Reduce Pain and Fatigue in Patients with FSHD: the GRIP on FSHD Study
- ClinicalTrials.gov ID
- NCT06712043
- Acronym / sponsor ID
- GRIPonFSHD / NL86789.091.24
- Conditions
- FSHD
- Keywords
- Personalized exercise, Rehabilitation, Aerobic exercise, Strength training, Balance training, Fatigue, Pain, Fatigability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
The goal of this intervention study is to determine the effect of a tailored exercise program (with aerobic, strength and balance training) in patients with FSHD.
The main aim is to determine the effect of the exercise program on pain and fatigue.
Participants will follow a 16 week training program with tailored exercises. The exercises will be prescribed via the app 'Physitrack'. After 16 weeks, the effect on pain, fatigue, fatigability, aerobic capacity, balance, physical function, sleep and the ability to participate in social activities will be determined.
Detailed description
Rationale: Pain and fatigue are two common and disabling symptoms in FSHD. No studies in FSHD have proven to reduce pain yet. (Aerobic) exercise has proven to reduce fatigue, however, current training guidelines are generic which can lead to overuse of injuries. The investigators expect that a personalized training program with aerobic exercise but also strength and balance training, that is adapted to a participants symptoms and wishes will provide a positive effect on pain and fatigue.
Objectives:
Primary objectives
- To determine the effect of a tailored exercise program by using the widely implemented exercise app "Physitrack" on experienced pain and fatigue in patients with FSHD.
- To investigate the relationship between perceived pain and fatigue and performance fatigability, disease severity, clinical phenotype, and level of activity in patients with FSHD Secondary objectives
- To determine the responsiveness of the performance fatigability test. 2. To investigate the influence of a decreasing performance fatigability on experienced fatigue 3. To provide input for new training guidelines for people with FSHD. Study design: Single group intervention study with historical control group. Study population: 50 individuals with FSHD >18 years Intervention: An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Main study parameters/endpoints:
The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale and the average daily pain score during 2 weeks are the primary endpoints.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this study includes: (1) two visits to the Radboudumc (approximately 3-4 hours, including a break) with physical test and questionnaires, (2) following a 16 week personalized exercise program, including filling in questionnaires about pain and fatigue and (3) wearing an activity tracker for 1 week before and after the study. Participants will have a weekly phone call with the researcher, and when participants will have complaints such as pain and/or fatigue, the training will be adapted. Therefore, the investigators expect that the risk will be minimal, and patient might experience the benefits of personalized training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single group intervention study with historical control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Personalised ExerciseAn individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app. |
| Historical control group | Active comparator | Behavioral: Historical control groupAerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years
- Verified diagnosis of FSHD type 1, based on the clinical criteria established by Padberg et al. (1991) (22).
- Category A or B of the four clinical categories according to the Comprehensive Clinical Evaluation Form (23), these patients have the most peculiar signs of the disease
- A CIS-fatigue score of ≥ 35
- Owning of and being able to use a smartphone
Key exclusion criteria (10 listed)
- Use of beta-blocker medication
- Presence of additional diseases likely to interfere with the measurements
- Psychological-psychiatric disorders
- A musculoskeletal injury that impairs exercising
- Scoliosis that impairs training
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 |
|---|---|---|
| Personalised ExerciseAn individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app. | Behavioural | Intervention group |
| Historical control groupAerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD) | Behavioural | Historical control group |
Primary outcome
Daily observed pain
Time frame: 16 weeks
Daily observed pain during a period of 2 weeks, measured with the Visual Analog Scale (VAS)
Fatigue
Time frame: 16 weeks
The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale.
12 secondary outcomes
Performance fatigability
Time frame: 16 weeks
Fatigue (VAS)
Time frame: 16 weeks
Aerobic capacity
Time frame: 16 weeks
Long function
Time frame: 16 weeks
Long function
Time frame: 16 weeks
Long function
Time frame: 16 weeks
Balance
Time frame: 16 weeks
Pain Questionnaire
Time frame: 16 weeks
Sleep
Time frame: 16 weeks
Social roles an participation
Time frame: 16 weeks
Physical Function
Time frame: 16 weeks
Physical activity
Time frame: 16 weeks
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 2 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for FSHD
RecruitingPhase 1/2
A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD
Facioscapulohumeral Muscular Dystrophy (FSHD)
RecruitingObservational study
Biomarker Development for Muscular Dystrophies
Myotonic Dystrophy, Duchenne Muscular Dystrophy
RecruitingPhase 1
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
FSHD - Facioscapulohumeral Muscular Dystrophy
Not yet recruitingPhase 2
A Study of SAT-3247 to Evaluate the Safety, Tolerability, and Efficacy in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
Facioscapulohumeral Muscular Dystrophy (FSHD)
Enrolling by invitationPhase 1/2
Study of SRP-1001 in Adult and Adolescent Participants With Facioscapulohumeral Muscular Dystrophy Type 1
Muscular Dystrophy, Facioscapulohumeral
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.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised Exercise in people with FSHD, run by Radboud University Medical Center.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ronne van Haaren - Pater (+31 24 36 68 195, Ronne.vanHaaren@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily observed pain (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 2 Dec 2024.