Actively Recruiting
Personalized Exercise Training for People With Rare Neuromuscular Disorders A Multi-center, Evaluator-blinded, Two Arm, Randomized Controlled Study Assessing Effects on Physical Function From Personalized Strength and Balance Exercise in Rehabilitation
Led by Oslo University Hospital · Updated on 2025-04-27
120
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
U
Universitetssykehuset i Nord-Norge HF
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of personalized exercise treatment on dynamic balance and physical function in adults with rare neuromuscular disorders such as Charcot-Marie-Tooth disease, Facioscapulohumeral Muscular Dystrophy, and Myotonic Dystrophy Type 1. This study aims to determine if the exercise intervention improves dynamic balance more than regular follow-up care, and if these improvements last over time. The study also explores associations between balance improvements and other health indicators like physical activity, body composition, and quality of life in 120 participants from Norway's four health regions. Participants are randomly assigned to one of two groups: an experimental group receiving a personalized exercise program or a control group receiving usual care. The exercise intervention includes two 12-day personalized training sessions at a rehabilitation center separated by a three-month digital program. The control group continues with their regular hospital and community health appointments as recommended. The study is evaluator-blinded and follows participants over several months. During the study, participants undergo assessments at baseline, 4 months, 10 months, and 16 months. These include dynamic balance tests using the Mini-Balance Evaluation Systems Test, fatigue scales, clinical strength and function measurements, metabolomics, body composition scans, neuromuscular ultrasound, physical activity monitoring, motor unit estimation, and quality-of-life questionnaires. The intervention group has additional follow-up assessments at 10 and 16 months. This comprehensive monitoring helps researchers understand the effects and sustainability of personalized exercise on physical function and health in this population.
CONDITIONS
Brief Title
Personalized Training for People With Rare Neuromuscular Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Facioscapulohumeral Muscular Dystrophy (FSHD), Myotonic Dystrophy Type 1 (DM1), or Charcot-Marie-Tooth disease (CMT)
- Age between 18 and 70 years at the time of consent
- Any gender
- Ability to stand, rise from a chair, and walk at least 10 meters with or without assistive devices
- Indication for rehabilitation confirmed by a neurologist or physiotherapist
- Ability to understand and follow instructions in Norwegian
- Capable of giving signed informed consent
You will not qualify if you...
- Pregnancy or planning to become pregnant
- Other neurological or non-neurological disorders affecting physical capacity, such as disabling arthritis, severe heart failure or cardiomyopathy, or ongoing cancer treatment
- Alcohol or drug abuse as recorded in medical charts
- History of not following medical advice or follow-up
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 months
Participants in the experimental group complete a 12-day personalized exercise program in a rehabilitation center, followed by a three-month digital exercise intervention, and then a second 12-day personalized exercise program in a rehabilitation center. Participants in the control group follow their usual care with hospital and community health appointments as recommended.
2 in-person rehabilitation visits of 12 days each and ongoing digital intervention over 3 months
Duration - Up to 12 months after treatment
Participants in the intervention group are assessed for longer-term outcomes at 10 and 16 months after baseline to monitor the effects of the personalized exercise training.
Follow-up visits at 10 months and 16 months for intervention group only
Trial Site Locations
Total: 5 locations
1
Haukeland University Hospital
Bergen, Norway, 5021
Not Yet Recruiting
2
Helse Møre and Romsdal HF (Molde Hospital)
Molde, Norway
Not Yet Recruiting
3
Namsos Hospital
Namsos, Norway, 7803
Not Yet Recruiting
4
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
5
University Hospital of North Norway
Tromsø, Norway, 9038
Actively Recruiting
Research Team
K
Kristin Ørstavik, MD, PhD
H
Hanne L Fossmo, PhD stud
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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