Heart-Brain Retraining for Stroke Rehabilitation
Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2012
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
August 1, 2018
CompletedAugust 31, 2018
August 1, 2018
2.3 years
February 24, 2014
July 2, 2018
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Secondary Outcomes (1)
The Fugl-Meyer Assessment (FMA)
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Other Outcomes (1)
The Stroke Impact Scale (SIS)
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Study Arms (3)
Repetitive Task Practice (RTP)
ACTIVE COMPARATORThis group focuses on RTP.
Voluntary cycling + RTP
EXPERIMENTALThis group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP
EXPERIMENTALThis group involves one biking session and one RTP session three times per week for eight weeks.
Interventions
This group will preform arm and hand therapy.
This group will preform arm and hand therapy and cycle on a bike.
This group will preform arm and hand therapy and cycle on a bike.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (4)
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.
PMID: 32918907DERIVEDLinder 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.
PMID: 31778659DERIVEDRosenfeldt 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.
PMID: 30543801DERIVEDLinder 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.
PMID: 26114455DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jay Alberts
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Alberts, PhD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 24, 2014
First Posted
March 4, 2014
Study Start
August 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
August 31, 2018
Results First Posted
August 1, 2018
Record last verified: 2018-08