NCT06712043

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

August 13, 2024

Last Update Submit

November 26, 2024

Conditions

FSHD

Keywords

Personalized exerciseRehabilitationAerobic exerciseStrength trainingBalance trainingFatiguePainFatigabilitySmartphone application

Outcome Measures

Primary Outcomes (2)

  • Daily observed pain

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

    16 weeks

  • Fatigue

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

    16 weeks

Secondary Outcomes (12)

  • Performance fatigability

    16 weeks

  • Fatigue (VAS)

    16 weeks

  • Aerobic capacity

    16 weeks

  • Long function

    16 weeks

  • Long function

    16 weeks

  • +7 more secondary outcomes

Study Arms (2)

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.

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)

Behavioral: Historical control group

Interventions

Personalised ExerciseBEHAVIORAL

An individualized exercise program consisting of aerobic exercises, strength exercises and balance exercises. The exercises will be prescribed via the Physitrack app.

Intervention group
Historical control groupBEHAVIORAL

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

Historical control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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 or using the app
  • Patient deprived of liberty or patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatiguePain

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Central Study Contacts

Ronne van Haaren - Pater

CONTACT

+31 24 36 68 195Ronne.vanHaaren@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Not possible in this situation
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Single group intervention study with historical control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2024

First Posted

December 2, 2024

Study Start

February 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share