Treadmill Training in Chronic MS: Efficacy and Cost-effectiveness

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.