Heart-Brain Retraining for Stroke Rehabilitation
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Task Practice (RTP)
Voluntary cycling + RTP
Assisted cycling + RTP
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Rehabilitation, Neuroplasticity, Task Practice
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging
- Fugl-Meyer Motor Score 19-55 in involved upper extremity
- Approval from patient's primary care 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
- Hypertrophic cardiomyopathy
- Severe 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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Repetitive Task Practice (RTP)
Voluntary cycling + RTP
Assisted cycling + RTP
Arm Description
This group focuses on RTP.
This group involves one biking session and one RTP session three times per week for eight weeks.
This group involves one biking session and one RTP session three times per week for eight weeks.
Outcomes
Primary Outcome Measures
Wolf Motor Function Test (WMFT)
This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
Secondary Outcome Measures
The Fugl-Meyer Assessment (FMA)
This is a 33 item assessment of post-stroke UE impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02076776
Brief Title
Heart-Brain Retraining for Stroke Rehabilitation
Official Title
Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to gain a better understanding of how different types of exercise can help people after a stroke. The investigators want to study if different types of exercise will improve the use of arm and hand function after a stroke.
Detailed Description
Stroke is the leading cause of disability in the United States with approximately 795,000 new or recurrent strokes per year. An estimated two thirds of patients post-stroke cannot incorporate the affected upper extremity (UE) into their activities of daily living. In addition, stroke survivors experience a 60% decrease in cardiovascular capacity, which contributed to disability and diminished quality of life. Developing rehabilitation techniques to optimize motor recovery while improving cardiovascular endurance would benefit the stroke population.
Animal studies using a forced exercise (FE) paradigm, in which the rodent is exercised on a motorized treadmill at a rate greater than its voluntary rate, indicate an endogenous increase in neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and glial-derived neurotrophic factor (GDNF). These neurotrophic factors are thought to underlie neuroplasticity and motor learning. It is hypothesized that patients with stroke, due to decreased motor cortical output, cannot sustain high rates of voluntary exercise necessary to trigger the endogenous release of neurotrophic factors; therefore, forced-exercise is necessary to augment their voluntary efforts and will be superior to voluntary exercise in facilitating motor recovery. When coupled with repetitive task practice (RTP) of the UE, an effective form of UE rehabilitation, FE will prime the brain for neuroplasticity. We have developed a safe and effective method of delivering forced-exercise to Parkinson's disease (PD) patients (NIH R21HD056316). Clinical and imaging data with PD patients indicate forced-exercise, but not voluntary exercise, triggers a neurophysiologic response in the central nervous system resulting in global improvements in motor and non-motor functioning and increased cortical and subcortical activation. The aim of this project is to conduct a preliminary trial to compare the effects of forced to voluntary exercise when coupled with RTP in promoting the recovery of motor function in patients with stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Exercise, Rehabilitation, Neuroplasticity, Task Practice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Repetitive Task Practice (RTP)
Arm Type
Active Comparator
Arm Description
This group focuses on RTP.
Arm Title
Voluntary cycling + RTP
Arm Type
Experimental
Arm Description
This group involves one biking session and one RTP session three times per week for eight weeks.
Arm Title
Assisted cycling + RTP
Arm Type
Experimental
Arm Description
This group involves one biking session and one RTP session three times per week for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Repetitive Task Practice (RTP)
Intervention Description
This group will preform arm and hand therapy.
Intervention Type
Behavioral
Intervention Name(s)
Voluntary cycling + RTP
Intervention Description
This group will preform arm and hand therapy and cycle on a bike.
Intervention Type
Behavioral
Intervention Name(s)
Assisted cycling + RTP
Intervention Description
This group will preform arm and hand therapy and cycle on a bike.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
Time Frame
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Secondary Outcome Measure Information:
Title
The Fugl-Meyer Assessment (FMA)
Description
This is a 33 item assessment of post-stroke UE impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Time Frame
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Other Pre-specified Outcome Measures:
Title
The Stroke Impact Scale (SIS)
Description
This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
Time Frame
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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
Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging
Fugl-Meyer Motor Score 19-55 in involved upper extremity
Approval from patient's primary care 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
Hypertrophic cardiomyopathy
Severe 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Alberts, PhD
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
PubMed Identifier
26114455
Citation
Linder SM, Rosenfeldt AB, Rasanow M, Alberts JL. Forced Aerobic Exercise Enhances Motor Recovery After Stroke: A Case Report. Am J Occup Ther. 2015 Jul-Aug;69(4):6904210010p1-8. doi: 10.5014/ajot.2015.015636.
Results Reference
derived
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Heart-Brain Retraining for Stroke Rehabilitation
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