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Testing a Tailored Home Exercise Program to Reduce Pain and Fatigue in Patients with FSHD.

ConditionFSHD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Use of beta-blocker medication

Presence of additional diseases likely to interfere with the measurements

Psychological-psychiatric disorders

A musculoskeletal injury that impairs exercising

Trial design

Design model

Sequential

Treatments tested in this trial

  • Personalised Exercise

    Behavioral

    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

    Behavioral

    Aerobic training (see study Voet 2024, Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Historical control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Daily observed pain

Daily observed pain during a period of 2 weeks, measured with the Visual Analog Scale (VAS)

Time frame
16 weeks
2

Fatigue

The chronic fatigue score assessed using the Checklist Individual Strength (CIS-fatigue) fatigue subscale.

Time frame
16 weeks

Secondary outcomes

1

Performance fatigability

The quadriceps isometric intermittent fatigue test (QIF test)

Time frame
16 weeks
2

Fatigue (VAS)

VAS fatigue

Time frame
16 weeks
3

Aerobic capacity

B-FIT Exercise test

Time frame
16 weeks
4

Long function

Maximal expiratory pressure (MEP)

Time frame
16 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Università di Pavia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: