ClinConnect ClinConnect Logo
Search / Trial NCT06712043

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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 26, 2024

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Personalized Exercise Rehabilitation Aerobic Exercise Strength Training Balance Training Fatigue Pain Fatigability Smartphone Application

ClinConnect Summary

This clinical trial is looking at how a special exercise program can help reduce pain and fatigue in patients with Facioscapulohumeral Muscular Dystrophy (FSHD), a condition that affects muscle strength. The program lasts for 16 weeks and includes exercises for aerobic fitness, strength, and balance. Participants will use a smartphone app called Physitrack to follow their personalized exercise plan. At the end of the trial, researchers will check how these exercises have impacted pain, fatigue, physical abilities, sleep, and overall social participation.

To participate, individuals must be over 18 years old and have a confirmed diagnosis of FSHD type 1. They should also be able to walk and use a smartphone. However, certain health conditions, such as heart or lung issues, psychological disorders, or recent medication changes, may prevent someone from joining. The trial is not yet recruiting participants, but it offers an opportunity for those who qualify to potentially improve their daily lives through a structured exercise routine.

Gender

ALL

Eligibility criteria

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

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported