Multiple Sclerosis and Heavy Progressive Resistance Training

Multiple Sclerosis Clinical Trial

Official title:

Multiple Sclerosis and Muscle Function - Effects of Heavy Progressive Resistance Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381576
• Other study ID #: 300976
• Status: Completed
• Phase: N/A
• First received: September 27, 2006
• Last updated: August 11, 2008
• Start date: November 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the present investigation is to determine whether MS patients can tolerate and benefit from heavy progressive resistance training. A second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training.

Description:

Multiple sclerosis (MS) patients are characterized by reduced muscle strength and functional capacity. For MS patients, improvements in muscle strength and thereby functional capacity, would have the potential to make both the daily living easier and to extend the time living independently. Attempts to improve muscle strength and function include the application of physical training, although the general advice to MS patients for many years has been to avoid participation in physical training. It has now been demonstrated that endurance training at low to moderate intensity is well tolerated by MS patients, but it only induces modest improvements in both muscle strength and functional capacity. Heavy progressive resistance training (HPRT) has proven to be the most effective means to improve muscle strength and functional capacity during daily activities in healthy older people. However, the effects of HPRT have not been investigated in randomised control trials in MS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Relapsing Remitting Multiple Sclerosis according to the McDonald criteria

• Expanded Disability Status Scale Score between 3,0-5,5

• Be able to walk at least 100m

• Be able to train twice a week at the University

Exclusion Criteria:

• Alcohol abuse, Alzheimer`s and pacemaker

• 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, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Resistance training
Intervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Sonderborg Hospital, The Danish Multiple Sclerosis Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength (isokinetic testing)		Before and after the intervention	No
Secondary	Functional capacity (Six minute walk test, 10m walk test, chair rise, stair climbing)		Before and after the intervention	No
Secondary	Muscle biopsies from m. vastus lateralis		Before and after the intervention	Yes
Secondary	% Fat (skinfold)		Before and after the intervention	No
Secondary	Blood samples (immunologic parameters)		Before and after the intervention	No
Secondary	Fatigue (Fatigue Severity Scale - FSS, Modified Fatigue Inventory - MFI-20)		Before and after the intervention	No
Secondary	HRQOL: SF36		Before and after the intervention	No
Secondary	Depression: Major Depression Inventory (MDI)		Before and after the intervention	No
Secondary	Surface EMG from m. vastus lateralis during MVC		Before and after the intervention	No