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.
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
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
Parallel
Exercise
Other interventionThe intervention includes 12-day personalized exercise program set in a rehabilitation center, followed by a three-month digital intervention and then a second 12-day personalized exercise program in a rehabilitation center.
Usual Care
Other interventionUsual care includes appointments at hospitals and in the community health system according to what has been recommended to that individual
Dynamic balance assessed using Mini-Balance Evalulation Systems Test (Mini-BESTest)
The primary outcome measure will be change in dynamic balance from pre-intervention to post-intervention. In addition, there will be two follow-up assessments.
Fatigue severity scale
Measurements of fatigue, 9 questions on a scale from 1 to 7. And a visual analogue fatigue scale
Clinical measures of strength and function
manual muscle testing, 30-s sit-to-stand, functional strength of neck and trunk, arm and hand function (9-HPT, Box and Block), walking function (10-mWT and 100-mTT), grip and pinch strength using dynamometers.
Global Metabolomics
dried blood samples for extracting signal metabolites of known importance in characterizing the metabolic status (e.g. lactate, amino acids, and fatty acids)
Dual Energy X-ray Absorptiometry
body composition from different regions of the body
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
Universitetssykehuset i Nord-Norge HF
Collaborator
Norwegian School of Sport Sciences
Collaborator
Namsos Hospital
Collaborator
Frambu Centre for Rare Disorders
Collaborator
Vigør Rehabilitation Hospital
Collaborator
Kastvollen Rehabilitation Centre
Collaborator
Norwegian University of Science and Technology
Collaborator
Haukeland University Hospital
Collaborator
Molde Hospital
Collaborator
Drammen sykehus
Collaborator
Vikersund Bad Rehabiliteringssenter AS
Collaborator
Røde Kors Haugland rehabilitation center
Collaborator
