Primary objectives1. 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…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
- Movement therapy
N.a.
Outcome measures
Primary outcome
<p>The chronic fatigue score assessed using the Checklist Individual Strength<br />
(CIS-fatigue) fatigue subscale and the daily observed pain score during 2 weeks<br />
are the primary endpoints. </p>
Secondary outcome
<p>Muscle function (MRC score), the Quadriceps Isometric Intermittent Fatigue<br />
test, B-FIT exercise test, Forced Vital Capacity, Mini-BESTest, physcial<br />
activity with an activity tracker, and questionnaires regarding pain, sleep,<br />
participation and physical function. </p>
Background summary
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. We 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.
Study objective
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
Intervention
An individualized exercise program consisting of aerobic exercises, strength
exercises and balance exercises. The exercises will be prescribed via the
Physitrack app.
Study burden and risks
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, we expect that the risk will be minimal, and patient might
experience the benefits of personalized training.
N. Voet
Reinier Postlaan 4
Nijmegen 6525 GC
Netherlands
(024) 3655286
Nicole.Voet@radboudumc.nl
N. Voet
Reinier Postlaan 4
Nijmegen 6525 GC
Netherlands
(024) 3655286
Nicole.Voet@radboudumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Age > 18 years
- Verified diagnosis of FSHD type 1 or 2, based on the clinical criteria established
by Padberg et al. (1991).
- Category A or B of the four clinical categories according to the
Comprehensive Clinical Evaluation Form, these patients have the most peculiar
signs of the disease
- A CIS-fatigue score of >= 35
- Owning and being able to use a smartphone
- Preserved ability to ambulate at the time of the selection
- No cardiological or pulmonary 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
- 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)
- 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
- Patient deprived of liberty or patient under guardianship
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86789.091.24 |
| Research portal | NL-005623 |