Clinical trial NCT01518660: Multiple Sclerosis and Progressive Resistance Training
Official title: Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis (Relapsing Remitting)
Keywords: Resistance Training
Strength Training
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Biogen
First posted: 2012-01-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

Detailed description: Exercise in general, and progressive resistance training (PRT) in particular, is regarded as an important tool in the rehabilitation of people with multiple sclerosis (MS).

Previous studies have reported positive effects of PRT on muscle strength, functional capacity, fatigue and quality of life. Also, a possible disease modifying effect has been proposed. However, the underlying physiological mechanisms that might explain these beneficial effects and the possible effects on disease progression are unresolved. Additionally, none of the previous studies has been concerned with the possible impact of MS progression type, gender and/or medication.

The purpose of this randomized, controlled, gender stratified trial is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* Diagnosed relapsing-remitting MS according to the McDonald criteria
* Expanded Disability Status Scale (EDSS) between 2.0 and 5.5
* Be able to train twice a week at the University
* Use interferon based medication

Exclusion Criteria:

* Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)
* Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
* Having had an attack in a period of 8 weeks prior to the start of the intervention period
* Having an attack during the intervention period
* Pregnancy
* Systematic resistance training in a period of 3 months prior to the start of the intervention period.
* Training adherence of less than 85%.

Primary outcomes:
measure: Blood-borne biomarkers
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Neuro-muscular function of knee extensors
timeFrame: Change from baseline to 24 weeks
measure: Walking performance
timeFrame: Change from baseline to 24 weeks
measure: Self-reported measures
timeFrame: Change from baseline to 24 weeks
measure: Brain volume
timeFrame: Change from baseline to 24 weeks
measure: Body Composition
timeFrame: Change from baseline to 24 weeks
measure: Thigh muscle cross-sectional area
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: MS Clinic, Department of Neurology, Aarhus University Hospital
city: Aarhus C
country: Denmark
facility: Sport Science, Aarhus University
Study officials:
affiliation: Sport Science, Department of Public Health, Aarhus University
name: Tue Kjølhede, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sport Science, Department of Public Health, Aarhus University
name: Ulrik Dalgas, Ph.D.
role: STUDY_CHAIR
affiliation: Sport Science, Department of Public Health, Aarhus University
name: Kristian Vissing, Ph.D.
role: STUDY_CHAIR
affiliation: MS Clinic, Department of Neurology, Aarhus University Hospital
name: Thor Petersen, Dr.med
role: STUDY_CHAIR
References: