Clinical trial NCT02494518: Forced Aerobic Exercise for Stroke Rehabilitation
Official title: Forced Aerobic Exercise for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
aerobic exercise
forced exercise
repetitive task practice
arm function
upper extremity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-07-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl Meyer Assessment
timeFrame: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
measure: Wolf Motor Function Test
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
measure: Stroke Impact Scale
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
measure: Metabolic Stress Test
timeFrame: Change from baseline to follow up assessments at end of 8 week intervention
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
measure: Center for Epidemiological Studies-Depression
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
measure: Processing Speed Test
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
measure: Nine Hole Peg Test
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
measure: Six Minute Walk Test
timeFrame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Susan Linder, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.