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.

Study Overview

• Status: Withdrawn
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • VA Maryland Health Care System, Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1	Behavioral: Exercise; Treadmill exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak VO2 Treadmill, Step activity monitors, Timed 8 meter walk	Pre study and 12 weeks Post study

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Christopher Bever, MD, VA Maryland Health Care System, Baltimore

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): September 1, 2011
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: June 2, 2006
• First Submitted That Met QC Criteria: June 2, 2006
• First Posted (Estimate): June 6, 2006

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; multiple sclerosis; treadmill
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: B3603-P (Other Grant/Funding Number: Department of Veterans Affairs)