Treadmill Training in Chronic MS: Efficacy and Cost-effectiveness

This study has been withdrawn prior to enrollment.
(Difficulty with recruiting)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00334100
First received: June 2, 2006
Last updated: October 7, 2014
Last verified: October 2014

June 2, 2006
October 7, 2014
April 2006
September 2011   (final data collection date for primary outcome measure)
Peak VO2 Treadmill, Step activity monitors, Timed 8 meter walk [ Time Frame: Pre study and 12 weeks Post study ] [ Designated as safety issue: No ]
  • The primary outcomes are safety and tolerability.
  • Safety assessed by recording falls, near falls and other adverse
  • events. Tolerability will be assessed by patient subjective
  • responses to trainers and drop outs also monitored.
Complete list of historical versions of study NCT00334100 on ClinicalTrials.gov Archive Site
Not Provided
  • Efficacy will be assessed by measuring EDSS, timed walking,
  • MRC scored manual motor testing, Ashworth scoring of spasticity,
  • economy of gait, peak VO2 and step activity monitoring carried
  • out at baseline and at the end of the study.
Not Provided
Not Provided
 
Treadmill Training in Chronic MS: Efficacy and Cost-effectiveness
Treadmill Training in Chronic MS: Efficacy and Cost-Effectiveness

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
Behavioral: Exercise
Treadmill exercise
Arm 1
Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2014
September 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00334100
B3603-P, B3603-P
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Christopher Bever, MD VA Maryland Health Care System, Baltimore
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP