Armergometry to Improve Mobility in MS
AMBOS
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMay 30, 2017
May 1, 2017
1.2 years
March 2, 2017
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minute walking test
maximum distance in 6 minutes
6 min.
Secondary Outcomes (5)
accelerometry
7 days
verbal learning and memory
30 minutes
peak oxygene uptake
20 minutes
brain atrophy
3 months
Brain derived neurotrophic factor
3 months change
Study Arms (2)
arm ergometry
EXPERIMENTALHome-based treatment after education in center, training following interval training plan on chip cards for 12 weeks at least 4-5 times/week
waiting group
ACTIVE COMPARATORtraining after 12 weeks.
Interventions
home based arm ergometry, at least 4-5 sessions/week for 12 weeks
Eligibility Criteria
You may qualify if:
- proven multiple sclerosis
- stable disease
- EDD 4,0-6,5
- being able to perform arm ergometry
You may not qualify if:
- relapse situation
- cognitive deficit unable to understand study
- cardivascular disease
- contraindication for MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Related Publications (1)
Heinrich I, Rosenthal F, Patra S, Schulz KH, Welsch GH, Vettorazzi E, Rosenkranz SC, Stellmann JP, Ramien C, Pottgen J, Gold SM, Heesen C. Arm Ergometry to Improve Mobility in Progressive Multiple Sclerosis (AMBOS)-Results of a Pilot Randomized Controlled Trial. Front Neurol. 2021 Jul 19;12:644533. doi: 10.3389/fneur.2021.644533. eCollection 2021.
PMID: 34349716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Heesen, Prof.
Universitätsklinikum Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2017
First Posted
May 10, 2017
Study Start
May 1, 2017
Primary Completion
July 1, 2018
Study Completion
December 31, 2018
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Enclose access to publication