Multiple Sclerosis and Progressive Resistance Training

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis (Relapsing Remitting)
• Intervention / Treatment: Behavioral: Training

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • MS Clinic, Department of Neurology, Aarhus University Hospital
  • Aarhus C, Denmark, 8000
    • Sport Science, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Training	Behavioral: Training; Bi-weekly progressive resistance training

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Biogen
• Investigators: Principal Investigator: Tue Kjølhede, M.Sc., Sport Science, Department of Public Health, Aarhus University; Study Chair: Ulrik Dalgas, Ph.D., Sport Science, Department of Public Health, Aarhus University; Study Chair: Kristian Vissing, Ph.D., Sport Science, Department of Public Health, Aarhus University; Study Chair: Thor Petersen, Dr.med, MS Clinic, Department of Neurology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Resistance Training; Strength Training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MS&PRT_SSAU_TK