Personalized exercise treatment for adults with rare neuromuscular disorders
Personalized Exercise Training for People With Rare Neuromuscular Disorders: a Multi-center, Evaluator-blinded, Two Arm, Randomized Controlled Study to Assess the Effects on Physical Function From Personalized Strength and Balance Exercise in a Rehabilitation Setting.
NA · Oslo University Hospital · NCT06708468
This study is testing if a personalized exercise program can help adults with rare neuromuscular disorders improve their balance and physical function better than regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 5 sites (Bergen and 4 other locations) |
| Trial ID | NCT06708468 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of personalized exercise treatment on dynamic balance and physical function in adults with rare neuromuscular disorders, specifically Charcot-Marie-Tooth disease, Facioscapulohumeral muscular dystrophy, and Myotonic Dystrophy Type 1. Participants will be divided into an intervention group receiving tailored exercise programs and a control group receiving usual care. The study aims to determine if the personalized training leads to superior improvements in dynamic balance and other health indicators compared to standard follow-up. The research will involve 120 individuals from various health institutions across Norway.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of FSHD, DM1, or CMT who are capable of basic mobility.
Not a fit: Patients with other significant neurological or non-neurological disorders affecting physical capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance physical function and quality of life for patients with rare neuromuscular disorders.
How similar studies have performed: While personalized exercise interventions have shown promise in other populations, this specific approach for rare neuromuscular disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A confirmed diagnosis of either FSHD, DM1 or CMT * 18-70 years of age at the time of signing the informed consent. * Any gender * Ability to stand, rise from a chair and walk at least 10 meters with or without any need of assistive devices * Indication for rehabilitation as confirmed by the treating neurologist or physiotherapist * Ability to understand and follow instructions in Norwegian * Capable of giving signed informed consent Exclusion Criteria: * Pregnancy or planning to become pregnant * Any other neurological or non-neurological disorders affecting physical capacity, such as disabling arthritis, severe heart-failure/cardiomyopathy, on-going cancer treatment * Alcohol or drug abuse as per their medical chart * History of non-compliance to medical advice/follow-up
Where this trial is running
Bergen and 4 other locations
- Haukeland University Hospital — Bergen, Norway (NOT_YET_RECRUITING)
- Helse Møre and Romsdal HF (Molde Hospital) — Molde, Norway (NOT_YET_RECRUITING)
- Namsos Hospital — Namsos, Norway (NOT_YET_RECRUITING)
- Oslo University Hospital — Oslo, Norway (RECRUITING)
- University Hospital of North Norway — Tromsø, Norway (RECRUITING)
Study contacts
- Principal investigator: Kristin Ørstavik, MD, PhD — Oslo University Hospital
- Study coordinator: Kristin Ørstavik, MD, PhD
- Email: krorstav@ous-hf.no
- Phone: +4792422126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuromuscular Diseases, Charcot Marie Tooth Disease, Facioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy Type 1, personalized training, rehabilitation, rare-neuromuscular disorders, motor unit number estimation