- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01067495
Adapted Cardiac Rehabilitation After Stroke
Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke
Despite the similarities between heart disease and stroke in terms of disease process and elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are not available for people with stroke.
The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking, risk factors, community integration and quality of life.
The investigators anticipate that cardiac rehabilitation may be appropriately adapted to accommodate individuals with stroke who have a range of functional abilities, and that this program is effective in improving aerobic capacity, walking ability and stroke risk factors. The investigators also anticipate participants will demonstrate improved community integration and quality of life following this program.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
There are many parallels between heart disease in stroke, including their cardiovascular etiologies, presence of co-morbidities and similarities in risk factors. Cardiac rehabilitation is a well-established and successful model of care for individuals with heart disease that is focused on exercise and risk factor modification. Yet analogous secondary prevention programs for the stroke program are not readily available.
The main research question is: What is the feasibility and effect of cardiac rehabilitation in individuals following stroke?
The objectives are:
- To determine if stroke survivors are able and willing to participate in a cardiac rehabilitation program. Specifically, to determine the feasibility of the cardiac rehabilitation program in individuals following stroke as determined by compliance to attendance and training requirements.
To determine if a cardiac rehabilitation program will have a meaningful benefit, among chronic stroke survivors, on:
- walking capacity and ability: considering functional capacity [endurance / distance] and quality [neuromotor control],
- community integration: considering quantity [activity monitors] and quality [index of reintegration to normal living] of activity
- health-related quality of life: as determined by stroke specific index
- risk factors for subsequent stroke: including exercise capacity, blood pressure, blood lipid profile
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M4G 1R7
- Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Chedoke-McMaster Stroke Assessment (CMSA) Scale Leg Score between 3 and 7
- At least 3 months post-stroke
- Ability to understand the process and instructions for exercise training and provide informed consent
- Ability to complete 6-minute walk test
Exclusion Criteria:
- Resting blood pressure greater than 160/100 despite medication
- Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
- Unstable angina
- Orthostatic blood pressure decrease of > 20 mm Hg with symptoms
- Hypertrophic cardiomyopathy
- Other musculoskeletal impairments which would limit the participant's ability to cycle or walk
- Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- Cognitive and/or behavioural issues that would limit participation in exercise testing and training
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Exercer
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Participants will participate in a 6-month cardiac rehabilitation exercise program.
This program will include aerobic and resistance training, and education sessions on risk factor management.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)
Délai: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Plasma lipid analysis, questionnaires pertaining to quality of life and community integration
Délai: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul Oh, MD, Toronto Rehabilitation Institute
- Chercheur principal: William E McIlroy, PhD, University of Waterloo
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSFO-SRA5977
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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