Forced Aerobic Exercise for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Forced Aerobic Exercise for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494518
• Other study ID #: 12-402
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 2017

Study information

• Verified date: December 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Forced Exercise & Upper Extremity Repetitive Task Practice

• Voluntary Exercise & Upper Extremity Repetitive Task Practice

• Stroke Education & Upper Extremity Repetitive Task Practice

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment	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.	Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Primary	Wolf Motor Function Test	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.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Primary	Stroke Impact Scale	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.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Primary	Metabolic Stress Test	Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.	Change from baseline to follow up assessments at end of 8 week intervention
Secondary	Action Research Arm Test	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.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Secondary	Center for Epidemiological Studies-Depression	Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Secondary	Processing Speed Test	Matching letters and symbols to test cognition. The reported data is change in total number correct.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Secondary	Nine Hole Peg Test	Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Secondary	Six Minute Walk Test	Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends