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Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)

23 novembre 2011 mis à jour par: Heather Arthur, McMaster University

The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure

The objective of this study is to compare the effect of monitored, home-based exercise versus hospital-based exercise on the quality of life of patients with congestive heart failure. Secondary objectives are to assess the effect of the intervention on exercise capacity and caregiver burden.

The investigators hypothesize that the exercise training in the home-based environment will be superior to hospital based exercise training.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Congestive heart failure (CHF) is a chronic disease that is associated with enormous burden of illness. Patients with CHF have diminished health-related quality of life, and due to the high demand associated with their everyday activities and self-management, there is consequently a burden upon family caregivers. Though exercise is a component of clinical practice guidelines for the management of CHF, previous studies have not examined the interrelationships among changes in exercise capacity, health-related quality of life (HRQL) and important predictor variables such as self-efficacy, as a result of exercise training in CHF patients. Furthermore, research to date has failed to examine whether a hospital-based or a home-based approach to exercise is the best-suited strategy for long-term adoption and benefit from exercise training. Thus, the most important effective approach to, and environment for, exercise training to improve the health and self-management of CHF patients has not yet been determined. This study will address some important gaps in the existing literature related to the benefits of exercise in CHF, specifically how different exercise approaches and strategies contribute to an individual's HRQL and self-efficacy.

This is a prospective, randomized controlled trial using a two-group, repeated measures design. Male and female patients with New York Heart Association (NYHA) Functional Class I-III CHF will be eligible to participate. Participants will be randomized to receive either supervised, hospital-based exercise or monitored home-based exercise. The participants in the study will train for a period of six months and will be reassessed six months following completion of the intervention to assess sustainability of any observed changes.

Type d'étude

Interventionnel

Inscription (Réel)

62

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences

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 et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • chronic stable heart failure
  • NYHA class I, II or III
  • willing and able to regularly attend a supervised exercise program
  • provision of written, informed consent

Exclusion Criteria:

  • unstable angina in the last month
  • recent acute MI (last 3 months) which precipitated heart failure
  • hospitalized for heart failure in past month
  • severe chronic pulmonary disease (FEV1 <40%)
  • uncontrolled hypertension (B/P >140/90)
  • orthopedic, neurological or psychiatric illness precluding participation in exercise
  • heart failure that is amenable to revascularization, which is planned in the near future
  • NYHA class IV

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
Expérimental: home based exercise training
Comportemental: Home-based exercise training

Participants in the home-based group will be advised to exercise, a minimum of 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Prescriptions will include the same elements of those for the hospital group:

  • 5-10 min warm-up
  • 30 min aerobic interval training (walking or stationary bicycle)
  • 10 min cool-down

Home-based participants will be asked to record their exercise in an exercise log book and will receive bi-weekly telephone calls from exercise personnel to monitor progress, assess and document adherence, revise the exercise prescription if necessary and provide support and education. Patient safety will be monitored during each call and serious health concerns will be relayed, with the patient's permission, to their primary health provider. Patients in this group will be encouraged to call the exercise specialist or kinesiologist with concerns or questions throughout the study.
Comparateur actif: supervised exercise training
Comportemental: Supervised hospital-based exercise training

Patients in the hospital-based group will participate in supervised, on-site, group exercise sessions 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Trained exercise personnel (kinesiologists and exercise specialists) will supervise these sessions. Exercise sessions will include:

  • 5-10 min of warm-up
  • 30 min of aerobic interval training using stationary cycles, treadmills and arm ergometers
  • 10 min of cool down

Exercise will be tracked by the participant in exercise log books.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in health-related quality of life (HRQL): Generic and disease specific
Délai: baseline, 3 months, 6 months, one year

The Medical Outcomes Short Form-36 will be used to measure generic HRQL.

The Minnesota Living with Heart Failure (MLQHF) Questionnaire will be used to measure disease specific HRQL.
baseline, 3 months, 6 months, one year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in exercise capacity (peak exercise oxygen uptake - VO2)
Délai: baseline, 3 months, 6 months, one year
PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
baseline, 3 months, 6 months, one year
Change in self-efficacy for exercise
Délai: baseline, 3 months, 6 months, one year
Self-efficacy for exercise will be measured using a self-efficacy for exercise scale developed for clinicial use among cardiac patients (Ewart & Taylor, 1985)
baseline, 3 months, 6 months, one year
Change in caregiver burden
Délai: baseline, 3 months, 6 months, one year
The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
baseline, 3 months, 6 months, one year

Collaborateurs et enquêteurs

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

Parrainer

McMaster University

Collaborateurs

Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Ontario

Les enquêteurs

  • Chercheur principal: Heather M Arthur, PhD, Hamilton Health Sciences Corporation
  • Chaise d'étude: Robert S McKelvie, MD, PhD, Hamilton Health Sciences Corporation
  • Chaise d'étude: Jennifer Kodis, MA, Hamilton Health Scienes
  • Chaise d'étude: Kevin Thorpe, MSc, University of Toronto
  • Chaise d'étude: Catherine Demers, MD, MSc, Hamilton Health Sciences Corporation

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 2003

Achèvement primaire (Réel)

1 juin 2006

Achèvement de l'étude (Réel)

1 novembre 2007

Dates d'inscription aux études

Première soumission

22 novembre 2011

Première soumission répondant aux critères de contrôle qualité

23 novembre 2011

Première publication (Estimation)

29 novembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

29 novembre 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 novembre 2011

Dernière vérification

1 novembre 2011

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NA 5147

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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