Multiple Sclerosis Clinical Trial
— AMBOSOfficial title:
Armergometry to Improve Mobility in Chronic Progressive Multiple Sclerosis
Chronic progressive multiple sclerosis patients will be randomised to home-based arm ergometry training for 12 weeks or a waitlist control group which will have access to the treatment after 12 weeks when primary endpoint assessment has been obtained. Assessments include clinical outcomes and questionnaires as well MRI imaging and transcranial magnetic stimulation paradigms. Primary endpoint will be the 6 minute walking test at week 12.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - proven multiple sclerosis - stable disease - EDD 4,0-6,5 - being able to perform arm ergometry Exclusion Criteria: - relapse situation - cognitive deficit unable to understand study - cardivascular disease - contraindication for MRI |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Deutsche Multiple Sklerose Gesellschaft Hamburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 minute walking test | maximum distance in 6 minutes | 6 min. | |
Secondary | accelerometry | walking speed through 7 days | 7 days | |
Secondary | verbal learning and memory | rapid and delayed recall | 30 minutes | |
Secondary | peak oxygene uptake | at step ergometry | 20 minutes | |
Secondary | brain atrophy | based on percentage brain volume chnage through 3 months | 3 months | |
Secondary | Brain derived neurotrophic factor | serum levels | 3 months change |
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