Multiple Sclerosis and Progressive Resistance Training

Multiple Sclerosis (Relapsing Remitting) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518660
• Other study ID #: MS&PRT_SSAU_TK
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: December 1, 2014
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (Relapsing Remitting)
• Sclerosis

Intervention

Behavioral:
• Training
Bi-weekly progressive resistance training

Locations

Country	Name	City	State
Denmark	MS Clinic, Department of Neurology, Aarhus University Hospital	Aarhus C
Denmark	Sport Science, Aarhus University	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Biogen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-borne biomarkers	Resting levels of bloodbourne biomarkers; Cytokines; Neurotrophins	Change from baseline to 24 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Body Composition	Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)	Change from baseline to 24 weeks	No
Secondary	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	No