Testing a Tailored Home Exercise Program to Reduce Pain and Fatigue in Patients with FSHD.
NCT ID: NCT06712043
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-02-28
2025-07-31
Brief Summary
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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
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Objectives:
Primary objectives
1. 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.
2. 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
1\. 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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Intervention group
An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Personalised Exercise
An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Historical control group
Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)
Historical control group
Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)
Interventions
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Personalised Exercise
An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.
Historical control group
Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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Università di Pavia
UNKNOWN
Radboud University Medical Center
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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NL86789.091.24
Identifier Type: -
Identifier Source: org_study_id