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Forced Aerobic Exercise for Stroke Rehabilitation

20. desember 2018 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

34

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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
Atferdsmessig: 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
Atferdsmessig: 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
Atferdsmessig: Stroke Education & Upper Extremity Repetitive Task Practice

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fugl Meyer Assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Action Research Arm Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Cleveland Clinic

Samarbeidspartnere

American Heart Association

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2015

Primær fullføring (Faktiske)

1. august 2017

Studiet fullført (Faktiske)

1. august 2017

Datoer for studieregistrering

Først innsendt

6. juli 2015

Først innsendt som oppfylte QC-kriteriene

8. juli 2015

Først lagt ut (Anslag)

10. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 12-402

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