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Multiple Sclerosis and Heavy Progressive Resistance Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381576
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : August 12, 2008
Sponsor:
Collaborators:
Sonderborg Hospital
The Danish Multiple Sclerosis Society
Information provided by:
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Resistance training Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Official Title: Multiple Sclerosis and Muscle Function - Effects of Heavy Progressive Resistance Training
Study Start Date : November 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
12 weeks of resistance training
Behavioral: Resistance training
Intervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living




Primary Outcome Measures :
  1. Muscle strength (isokinetic testing) [ Time Frame: Before and after the intervention ]

Secondary Outcome Measures :
  1. Functional capacity (Six minute walk test, 10m walk test, chair rise, stair climbing) [ Time Frame: Before and after the intervention ]
  2. Muscle biopsies from m. vastus lateralis [ Time Frame: Before and after the intervention ]
  3. % Fat (skinfold) [ Time Frame: Before and after the intervention ]
  4. Blood samples (immunologic parameters) [ Time Frame: Before and after the intervention ]
  5. Fatigue (Fatigue Severity Scale - FSS, Modified Fatigue Inventory - MFI-20) [ Time Frame: Before and after the intervention ]
  6. HRQOL: SF36 [ Time Frame: Before and after the intervention ]
  7. Depression: Major Depression Inventory (MDI) [ Time Frame: Before and after the intervention ]
  8. Surface EMG from m. vastus lateralis during MVC [ Time Frame: Before and after the intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381576


Locations
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Denmark
MS Clinic, Department of Neurology, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Sports Science, University of Aarhus
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Sonderborg Hospital
The Danish Multiple Sclerosis Society
Investigators
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Principal Investigator: Ulrik Dalgas, Ph.d. Stud. Department of Sports Science, University of Aarhus
Study Chair: Thorsten Ingemann-Hansen, Professor Department of Sports Science, University of Aarhus
Study Chair: Egon Stenager, MD MS clinic, Department of Neurology, Sonderborg Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Department of sports science, Aarhus University
ClinicalTrials.gov Identifier: NCT00381576    
Other Study ID Numbers: 300976
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: August 12, 2008
Last Verified: August 2008
Keywords provided by University of Aarhus:
Resistance training
Strength training
Training adaptations
CNS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases