Personalized Training for People With Rare Neuromuscular Disorders
NCT ID: NCT06708468
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-12-13
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
The experimental group receives four-months of exercise-based intervention
Exercise
The 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.
Control
The control group follows usual care
Usual Care
Usual care includes appointments at hospitals and in the community health system according to what has been recommended to that individual
Interventions
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Exercise
The 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
Usual care includes appointments at hospitals and in the community health system according to what has been recommended to that individual
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Universitetssykehuset i Nord-Norge HF
UNKNOWN
Norwegian School of Sport Sciences
OTHER
Namsos Hospital
OTHER
Frambu Centre for Rare Disorders
UNKNOWN
Vigør Rehabilitation Hospital
UNKNOWN
Kastvollen Rehabilitation Centre
UNKNOWN
Norwegian University of Science and Technology
OTHER
Haukeland University Hospital
OTHER
Molde Hospital
OTHER
Drammen sykehus
OTHER
Vikersund Bad Rehabiliteringssenter AS
UNKNOWN
Røde Kors Haugland rehabilitation center
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Kristin Ørstavik
head of Section, MD, PhD
Principal Investigators
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Kristin Ørstavik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Helse Møre and Romsdal HF (Molde Hospital)
Molde, , Norway
Namsos Hospital
Namsos, , Norway
Oslo University Hospital
Oslo, , Norway
University Hospital of North Norway
Tromsø, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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760722
Identifier Type: -
Identifier Source: org_study_id
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