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Forced Aerobic Exercise for Stroke Rehabilitation

20 décembre 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

34

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Ohio
      • Cleveland, Ohio, États-Unis, 44195
        • Cleveland Clinic

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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
Comportemental: Forced Exercise & Upper Extremity Repetitive Task Practice
Comparateur actif: 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
Comportemental: Voluntary Exercise & Upper Extremity Repetitive Task Practice
Comparateur actif: 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
Comportemental: Stroke Education & Upper Extremity Repetitive Task Practice

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fugl Meyer Assessment
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Action Research Arm Test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Cleveland Clinic

Collaborateurs

American Heart Association

Les enquêteurs

  • Chercheur principal: Susan Linder, PT, DPT, NCS, The Cleveland Clinic

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2015

Achèvement primaire (Réel)

1 août 2017

Achèvement de l'étude (Réel)

1 août 2017

Dates d'inscription aux études

Première soumission

6 juillet 2015

Première soumission répondant aux critères de contrôle qualité

8 juillet 2015

Première publication (Estimation)

10 juillet 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mars 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 décembre 2018

Dernière vérification

1 décembre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 12-402

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