Forced Aerobic Exercise for Stroke Rehabilitation



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:3/30/2019
Start Date:July 2015
End Date:August 2017

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The purpose of the study is to determine if performing different types of aerobic exercise
(cycling) before upper extremity exercises will help to improve outcomes after stroke.

The goal of this study is to determine the potential for forced aerobic exercise to augment
the recovery of motor function in individuals with stroke. Current approaches to stroke
rehabilitation involve intensive, therapist-directed task practice that is both expensive and
in some cases, ineffective in fostering functional neuromotor recovery. The identification of
a safe, cost-effective approach, such as forced aerobic exercise, to augment the recovery of
function achieved through task practice while simultaneously decreasing the cardiovascular
risk factors prevalent in stroke survivors would be significant to rehabilitation and stroke
communities.

Animal studies along with preliminary human data indicate a specific type of aerobic exercise
(AE), forced aerobic exercise (FE), may be ideal in facilitating motor recovery associated
with repetitive task practice (RTP). The hypothesis is that that deficits in afferent input
and motor cortical output following stroke prevents patients from achieving and maintaining
an exercise intensity that is sufficient for facilitating motor recovery; therefore, FE is
needed to augment their voluntary efforts and achieve greater gains in recovery. In previous
research, a safe lower extremity FE intervention was initially applied to individuals with
Parkinson's disease and subsequently to individuals with stroke. Preliminary results indicate
that those completing an 8-week FE intervention paired with an abbreviated session of RTP
exhibited significantly greater improvement in Fugl-Meyer scores at end of treatment despite
completing 40% fewer RTP repetitions, compared to those receiving voluntary-rate aerobic
exercise (VE) and RTP and time-matched RTP only. Improvements in cardiovascular fitness and
lower extremity motor function were also evident in both groups that engaged in aerobic
exercise (FE and VE). Positive results from a preliminary trial indicate safety, feasibility,
and initial efficacy of combining two modes of aerobic exercise training with RTP provide
rationale for a systematic and larger scale trial to determine the precise role of aerobic
exercise, forced and voluntary, in facilitating motor recovery following stroke.

For this study, 30 individuals with chronic stroke will be randomized into one of the
following groups: FE = RTP, VE + RTP or patient education and RTP. All three groups will
receive an identical dose of contact time over 8 weeks (3X per week). An intervention group
receiving a 45-minute session of patient education paired with RTP will serve as the
non-exercise control. Clinical and biomechanical outcomes measuring change in upper extremity
motor function, lower extremity motor function, and cardiovascular fitness will provide the
most complete picture, to date, on the potential neurologic effects of AE (forced and
voluntary) on motor recovery and brain function in humans with stroke.

Inclusion Criteria:

- Able to provide informed consent

- At least 6 months post diagnosis of single ischemic stroke, confirmed with
neuroimaging

- Fugl-Meyer Motor Score 19-55 in involved upper extremity

- Approval from patient's physician

- Age between 18 and 85 years

Exclusion Criteria:

- Hospitalization for myocardial infarction, congestive heart failure, or heart surgery
(CABG or valve replacement) within 3 months of study enrollment

- Serious cardiac arrhythmia

- Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac
pacemaker, pulmonary embolus)

- Other medical or musculoskeletal contraindication to exercise

- Significant cognitive impairment (unable to follow 1-2 step commands) or major
psychiatric disorder (major depression, generalized anxiety) that will cause
difficulty in study participation

- Anti-spasticity injection (botox) in upper extremity within 3 months of study
enrollment

- Pregnancy

- Unstable blood pressure at rest or with exercise
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-2599
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