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Forced Aerobic Exercise for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forced Exercise & Upper Extremity Repetitive Task Practice
Voluntary Exercise & Upper Extremity Repetitive Task Practice
Stroke Education & Upper Extremity Repetitive Task Practice
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Forced Exercise & Upper Extremity Repetitive Task Practice

Voluntary Exercise & Upper Extremity Repetitive Task Practice

Stroke Education & Upper Extremity Repetitive Task Practice

Arm Description

Participants will perform the following: 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 45 minutes of upper extremity repetitive arm exercises

Participants will perform the following: 45 minutes of cycling on a recumbent stationary bike at your self-selected speed 45 minutes of upper extremity repetitive arm exercises

Participants will perform the following: 45 minutes of stroke education 45 minutes of upper extremity repetitive arm exercises

Outcomes

Primary Outcome Measures

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.
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.
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.
Metabolic Stress Test
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.

Secondary Outcome Measures

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.
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.
Processing Speed Test
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Nine Hole Peg Test
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Six Minute Walk Test
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.

Full Information

First Posted
July 6, 2015
Last Updated
December 20, 2018
Sponsor
The Cleveland Clinic
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT02494518
Brief Title
Forced Aerobic Exercise for Stroke Rehabilitation
Official Title
Forced Aerobic Exercise for Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forced Exercise & Upper Extremity Repetitive Task Practice
Arm Type
Active Comparator
Arm Description
Participants will perform the following: 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 45 minutes of upper extremity repetitive arm exercises
Arm Title
Voluntary Exercise & Upper Extremity Repetitive Task Practice
Arm Type
Active Comparator
Arm Description
Participants will perform the following: 45 minutes of cycling on a recumbent stationary bike at your self-selected speed 45 minutes of upper extremity repetitive arm exercises
Arm Title
Stroke Education & Upper Extremity Repetitive Task Practice
Arm Type
Active Comparator
Arm Description
Participants will perform the following: 45 minutes of stroke education 45 minutes of upper extremity repetitive arm exercises
Intervention Type
Behavioral
Intervention Name(s)
Forced Exercise & Upper Extremity Repetitive Task Practice
Intervention Type
Behavioral
Intervention Name(s)
Voluntary Exercise & Upper Extremity Repetitive Task Practice
Intervention Type
Behavioral
Intervention Name(s)
Stroke Education & Upper Extremity Repetitive Task Practice
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment
Description
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.
Time Frame
Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Title
Wolf Motor Function Test
Description
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.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Title
Stroke Impact Scale
Description
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.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Title
Metabolic Stress Test
Description
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.
Time Frame
Change from baseline to follow up assessments at end of 8 week intervention
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
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.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Title
Center for Epidemiological Studies-Depression
Description
Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Title
Processing Speed Test
Description
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Title
Nine Hole Peg Test
Description
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Title
Six Minute Walk Test
Description
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Time Frame
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Linder, PT, DPT, NCS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32918907
Citation
Linder SM, Davidson S, Rosenfeldt A, Lee J, Koop MM, Bethoux F, Alberts JL. Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke. Arch Phys Med Rehabil. 2021 Jan;102(1):1-8. doi: 10.1016/j.apmr.2020.08.006. Epub 2020 Sep 9.
Results Reference
derived
PubMed Identifier
31778659
Citation
Linder SM, Davidson S, Rosenfeldt A, Penko A, Lee J, Koop MM, Phelan D, Alberts JL. Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions. Arch Phys Med Rehabil. 2020 Apr;101(4):717-721. doi: 10.1016/j.apmr.2019.10.187. Epub 2019 Nov 25.
Results Reference
derived
PubMed Identifier
30543801
Citation
Rosenfeldt AB, Linder SM, Davidson S, Clark C, Zimmerman NM, Lee JJ, Alberts JL. Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis. Arch Phys Med Rehabil. 2019 May;100(5):923-930. doi: 10.1016/j.apmr.2018.11.011. Epub 2018 Dec 10.
Results Reference
derived

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Forced Aerobic Exercise for Stroke Rehabilitation

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