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.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Helse Møre and Romsdal HF (Molde Hospital)
NOT_YET_RECRUITING
Molde
Namsos Hospital
NOT_YET_RECRUITING
Namsos
Oslo University Hospital
RECRUITING
Oslo
University Hospital of North Norway
RECRUITING
Tromsø
Contact Information
Primary
Kristin Ørstavik, MD, PhD
krorstav@ous-hf.no
+4792422126
Backup
Hanne L Fossmo, PhD stud
halufo@ous-hf.no
+4793630606
Time Frame
Start Date: 2024-12-13
Estimated Completion Date: 2028-12
Participants
Target number of participants: 120
Treatments
Experimental: Intervention
The experimental group receives four-months of exercise-based intervention
Active_comparator: Control
The control group follows usual care
Sponsors
Collaborators: Vigør Rehabilitation Hospital, Namsos Hospital, Haukeland University Hospital, Universitetssykehuset i Nord-Norge HF, Kastvollen Rehabilitation Centre, Norwegian School of Sport Sciences, Frambu Centre for Rare Disorders, Røde Kors Haugland rehabilitation center, Vikersund Bad Rehabiliteringssenter AS, Molde Hospital, Norwegian University of Science and Technology, Drammen sykehus
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov