Forced Aerobic Exercise for Stroke Rehabilitation
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Forced Exercise & Upper Extremity Repetitive Task Practice
Participants will perform the following:
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Aktivní komparátor: Voluntary Exercise & Upper Extremity Repetitive Task Practice
Participants will perform the following:
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Aktivní komparátor: Stroke Education & Upper Extremity Repetitive Task Practice
Participants will perform the following:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fugl Meyer Assessment
Časové okno: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
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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.
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Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
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Wolf Motor Function Test
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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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.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Stroke Impact Scale
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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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.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Metabolic Stress Test
Časové okno: Change from baseline to follow up assessments at end of 8 week intervention
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Cycling test to measure cardiovascular fitness.
The data reported is the change in VO2peak.
Higher scores indicate higher aerobic capacities.
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Change from baseline to follow up assessments at end of 8 week intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Action Research Arm Test
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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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.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Center for Epidemiological Studies-Depression
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Depression questionnaire.
The reported data is change in total score.
Scores range from 0-60, and lower scores indicate decreased risk of depression.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Processing Speed Test
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Matching letters and symbols to test cognition.
The reported data is change in total number correct.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Nine Hole Peg Test
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Transferring pegs into a fitted hole to measure hand function.
The reported data is change in average time to complete.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Six Minute Walk Test
Časové okno: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Distance walked in 6 minutes to measure cardiovascular fitness.
The reported data is change in total distance traveled.
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Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Susan Linder, PT, DPT, NCS, The Cleveland Clinic
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
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Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12-402
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