Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04906057 |
Other study ID # |
19-1003 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 6, 2021 |
Est. completion date |
December 1, 2023 |
Study information
Verified date |
September 2022 |
Source |
The Cleveland Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This project will investigate the feasibility and initial efficacy of two aerobic exercise
training approaches, forced and voluntary, to improve motor function in persons with multiple
sclerosis (MS). We hypothesize that intensive aerobic exercise training elicits a
neurorepairative and neurorestorative response on the central nervous system, which may
improve motor function as it relates to gait and mobility. Should aerobic cycling, forced or
voluntary, improve gait and functional mobility in persons with MS, it would serve as a new
model to restoring function, rather than current models that focus on compensation.
Description:
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the
central nervous system characterized by progressive loss of motor function, cognitive
function, in addition to symptoms of fatigue and depression. These motor and non-motor
symptoms negatively affect the individuals' walking ability, functional mobility, quality of
life, ability to maintain gainful employment, and social engagement. Identifying
rehabilitation approaches that may delay disease progression or restore lost neurologic
function would have considerable impact in the field. The goal of this project is to
investigate the feasibility and initial efficacy of forced or voluntary aerobic exercise
training to improve gait, functional mobility, fatigue and quality of life in persons with
multiple sclerosis (PwMS). Current rehabilitative approaches for PwMS focus on training
compensatory strategies rather than restoring neurological function. Substantial evidence
indicates that aerobic exercise (AE) training has the potential to enhance neurological
function by restoring and repairing damaged cells, leading to improvements in gait, balance,
and cognitive function in PwMS. Despite evidence of the potential disease-modifying
properties of AE, numerous physical, behavioral, and logistical barriers prevent PwMS from
achieving and maintaining AE of sufficient intensity and duration to capitalize on the
neurophysiologic benefits of training. Forced exercise (FE) is a novel approach to AE
training that has been successfully applied to individuals with Parkinson's disease and
stroke, in which the voluntary efforts of the individual are augmented, allowing for
disease-altering effects of intensive exercise training. During FE, pedaling cadence on a
stationary cycle is augmented by a motor to assist, but not replace, the voluntary efforts of
the individual. It is hypothesized that PwMS cannot sustain high rates of voluntary exercise
necessary to elicit neural repair; therefore, FE is necessary to overcome physical,
behavioral and logistical barriers to enhance neuroplasticity to improve gait, QOL, and the
ability to participate in life activities. Positive results from our FE trials in Parkinson's
disease and stroke have guided us in designing the scientific methodology for the proposed
trial in PwMS. Twenty adults with relapsing-remitting MS and mild to moderate gait impairment
will be randomized to undergo 1) FE or 2) voluntary aerobic exercise (VE). Both groups will
attend 2X/week for 12 weeks. Exercise variables will be collected for each session as a
measure of feasibility to determine how PwMS respond to each exercise approach. Clinical,
biomechanical, and self-reported outcomes will be gathered prior to, after, and 4-weeks after
the intervention to determine the effects of both modes of exercise on spatiotemporal and
kinematic characteristics of gait, functional mobility, balance, fatigue, physical activity
levels, and quality of life. Should our findings confirm our hypothesis that intensive
exercise training can have disease-altering effects, a new direction for MS rehabilitation
approaches would ensue, empowering PwMS to take control of their disease to improve function
and reduce disability.