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Forced Aerobic Exercise for Stroke Rehabilitation

20 december 2018 uppdaterad av: Susan Linder, The Cleveland Clinic
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

34

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Forced Exercise & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 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
  2. 45 minutes of upper extremity repetitive arm exercises
Beteende: Forced Exercise & Upper Extremity Repetitive Task Practice
Aktiv komparator: Voluntary Exercise & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
  2. 45 minutes of upper extremity repetitive arm exercises
Beteende: Voluntary Exercise & Upper Extremity Repetitive Task Practice
Aktiv komparator: Stroke Education & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of stroke education
  2. 45 minutes of upper extremity repetitive arm exercises
Beteende: Stroke Education & Upper Extremity Repetitive Task Practice

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fugl Meyer Assessment
Tidsram: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
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.
Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Wolf Motor Function Test
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Stroke Impact Scale
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Metabolic Stress Test
Tidsram: Change from baseline to follow up assessments at end of 8 week intervention
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.
Change from baseline to follow up assessments at end of 8 week intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Action Research Arm Test
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Center for Epidemiological Studies-Depression
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Processing Speed Test
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Nine Hole Peg Test
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Six Minute Walk Test
Tidsram: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Cleveland Clinic

Samarbetspartners

American Heart Association

Utredare

  • Huvudutredare: Susan Linder, PT, DPT, NCS, The Cleveland Clinic

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2015

Primärt slutförande (Faktisk)

1 augusti 2017

Avslutad studie (Faktisk)

1 augusti 2017

Studieregistreringsdatum

Först inskickad

6 juli 2015

Först inskickad som uppfyllde QC-kriterierna

8 juli 2015

Första postat (Uppskatta)

10 juli 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 december 2018

Senast verifierad

1 december 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 12-402

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