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NCT06708468 | RECRUITING | Neuromuscular Diseases (NMD)

Personalized Training for People With Rare Neuromuscular Disorders
Sponsor:

Oslo University Hospital

Information provided by (Responsible Party):

Kristin Ørstavik

Brief Summary:

The goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: Charcot-Marie-Tooth (CMT), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy Type 1 (DM1). The key objectives are: 1. To investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group 2. To investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up 3. To investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life. This is a national study and will involve 120 individuals with rare-neuromuscular disorders from Norway's four health regions.

Condition or disease

Neuromuscular Diseases (NMD)

Charcot Marie Tooth Disease (CMT)

Facioscapulohumeral Muscular Dystrophy

Myotonic Dystrophy Type 1 (DM1)

Intervention/treatment

Exercise

Usual Care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
Masking Description : The evaluators will be blinded to the treatment group of the participants. It is not possible to blind the participants themselves; however, they will be asked not to share their group allocation with the others, including the evaluators. A staff member may unblind the intervention assignment for any participant with a serious adverse event.
Primary Purpose : TREATMENT
Official Title : 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.
Actual Study Start Date : 2024-12-13
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Personalized Training for People With Rare Neuromuscular Disorders

Location Details

NCT06708468

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

Norway,

Haukeland University Hospital

Bergen, Norway, 5021

NOT YET RECRUITING

Norway,

Health Møre and Romsdal HF (Molde Hospital)

Mould, Norway,

NOT YET RECRUITING

Norway,

Namsos Hospital

Namsos, Norway, 7803

RECRUITING

Norway,

Oslo University Hospital

Oslo, Norway, 0424

RECRUITING

Norway,

University Hospital of North Norway

Tromsø, Norway, 9038