Multiple Sclerosis and Progressive Resistance Training

Study Overview
=================
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.

Official Title
-----------------
Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training

Conditions
-----------------
Multiple Sclerosis (Relapsing Remitting)

Intervention / Treatment
-----------------
* Behavioral: Training


Participation Criteria
=================
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%.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br> | Behavioral: Training<br>* Bi-weekly progressive resistance training<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood-borne biomarkers | Resting levels of bloodbourne biomarkers; Cytokines Neurotrophins | Change from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-muscular function of knee extensors | By use of an isokinetic dynamometer, EMG and stimulation equipment the following will be assessed for the knee extensors; Maximal muscle strength Surface EMG Central activation ratio | Change from baseline to 24 weeks | 
| Walking performance | Walking performance will be assessed by the; Two minute walk test 25-foot walk test Chair rise test Stair climb test | Change from baseline to 24 weeks | 
| Self-reported measures | The self-reported measures contains questionnaires regarding; Fatigue (Fatigue Severity Scale, Modifies Fatigue Impact Scale) Health-Related Quality of Life (SF-36) Depression (Major Depression Inventory) Disease impact (MS Impact Scale 29) Walking Performance (MS Walking Scale 12) | Change from baseline to 24 weeks | 
| Brain volume | MRI-scans of the head will provide the following measurements; Brain volume (analysed with SIENA) Plaque incidence | Change from baseline to 24 weeks | 
| Body Composition | Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220) | Change from baseline to 24 weeks | 
| Thigh muscle cross-sectional area | MRI-scans of the thigh will provide cross-sectional area of m. quadriceps m. hamstring | Change from baseline to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance Training, Strength Training