Forced Aerobic Exercise for Stroke Rehabilitation

Not Applicable

Completed

Conditions: Stroke

Interventions: Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice
Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice
Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice

Registration Number: NCT02494518

Lead Sponsor: The Cleveland Clinic

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Voluntary Exercise & Upper Extremity Repetitive Task Practice	Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education & Upper Extremity Repetitive Task Practice	Stroke Education & Upper Extremity Repetitive Task Practice	Participants will perform the following: 1. 45 minutes of stroke education 2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise & Upper Extremity Repetitive Task Practice	Forced Exercise & Upper Extremity Repetitive Task Practice	Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment	Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends	Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.
Wolf Motor Function Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.
Stroke Impact Scale	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.
Metabolic Stress Test	Change from baseline to follow up assessments at end of 8 week intervention	Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.
Center for Epidemiological Studies-Depression	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Processing Speed Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Matching letters and symbols to test cognition. The reported data is change in total number correct.
Nine Hole Peg Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Six Minute Walk Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.