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Treadmill Training in Chronic MS: Efficacy and Cost-Effectiveness
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, February 2009
First Received: June 2, 2006   Last Updated: February 2, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00334100
  Purpose

The purpose of the study is to determine whether treadmill training is safe and beneficial in patients with walking difficulty because of multiple sclerosis.


Condition Intervention
Multiple Sclerosis
Behavioral: Exercise

MedlinePlus related topics: Exercise and Physical Fitness Multiple Sclerosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Treadmill Training in Chronic MS: Efficacy and Cost-Effectiveness

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Peak VO2 Treadmill, Step activity monitors, Timed 8 meter walk [ Time Frame: Pre study and 12 weeks Post study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Exercise
Treadmill exercise

Detailed Description:

Multiple sclerosis is a chronic inflammatory demyelinating disease of the central nervous system, which can cause episodic, static or progressive disability. Frequently, MS causes weakness and spasticity of the legs leading to gait abnormalities and immobility. Rehabilitation has been widely used in MS but has been the subject of limited investigation. In particular, traditional thinking in MS providers was that aerobic exercise could cause worsening of symptoms in some patients and should generally be avoided. Recent studies suggest that both aerobic exercise is tolerated by most patients and improves fitness. In a recent study however, training with bicycle ergometers did not translate into improved biomechanics of gait. This suggests that aerobic training may need to be coupled to task specific training to produce improved gait. With recent changes in medical care focusing on cost containment, studies supporting the effectiveness and cost-effectiveness of rehabilitation interventions are needed.

Studies from the stroke literature suggest that task specific training may be useful in promoting motor reorganization in the cortex, reversing muscle wasting and improving cardiovascular de-conditioning. In particular, we have examined the use of treadmill training in patients with chronic hemiparesis due to stroke and have found that a course of training can improve walking ability, can cause an increase in motor representation of the effected limb as measured by fMRI, can increase muscle mass as measured by thigh CT and muscle biopsy, and can improve cardiovascular fitness as measured by treadmill stress testing. Proposed is a pilot study testing a program of treadmill training in patients with chronic leg weakness and spasticity due to MS causing chronic gait problems. The primary objectives of this pilot study are to demonstrate the safety and tolerability of the treadmill training program in MS patients and to obtain preliminary data on outcomes to use to determine the sample size for a larger trial designed to document efficacy and cost-effectiveness. Forty MS patients with impaired ambulation will be randomized to a 3 month program of treadmill training or a 3 month education and counseling program with attention equal to the treadmill trained group. Both groups will be followed for a total of 6 months. The treadmill training will be carried out in the Senior Exercise Research Center at the Baltimore VAMC. Outcome measures will include measures of leg strength and spasticity, disability (EDSS), walking ability, cardiovascular fitness, Quality of Life, depression, and healthcare costs and utilization (compared to the year prior to enrollment). The results of this pilot study will be used to design and gain support for a study sized to measure efficacy and cost effectiveness.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic definite multiple sclerosis
  • Visible paraparetic gait deficits
  • EDSS 4 to 6.5
  • Last 12 months of care in VHS
  • Competent to provide consent and carry out study procedures
  • Pass the Functional Mobility Entry Test

Exclusion Criteria:

  • Performing 20 minutes or more of aerobic exercise 3X per week
  • Alcohol consumption over 2 oz liquor, 8 oz wine, 24 oz beer per day
  • Cardiac history
  • Significant medical history
  • Significant neurological history
  • Relapsing MS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334100

Contacts
Contact: Adam Swartzendruber, MS (410) 605-7000 ext 4805 aswartze@grecc.umaryland.edu
Contact: Shereece Singleton (410) 605-7000 ext 5413 ssinglet@grecc.umaryland.edu

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Christopher Bever, MD     410-605-7130     christopher.bever@va.gov    
Principal Investigator: Christopher Bever, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher Bever, MD VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Bever, Christopher - Principal Investigator )
Study ID Numbers: B3603P
Study First Received: June 2, 2006
Last Updated: February 2, 2009
ClinicalTrials.gov Identifier: NCT00334100     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
multiple sclerosis
treadmill

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 06, 2009