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

23 de noviembre de 2011 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

62

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Comparador activo: supervised 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in health-related quality of life (HRQL): Generic and disease specific
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in exercise capacity (peak exercise oxygen uptake - VO2)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Heather M Arthur, PhD, Hamilton Health Sciences Corporation
  • Silla de estudio: Robert S McKelvie, MD, PhD, Hamilton Health Sciences Corporation
  • Silla de estudio: Jennifer Kodis, MA, Hamilton Health Scienes
  • Silla de estudio: Kevin Thorpe, MSc, University of Toronto
  • Silla de estudio: Catherine Demers, MD, MSc, Hamilton Health Sciences Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2003

Finalización primaria (Actual)

1 de junio de 2006

Finalización del estudio (Actual)

1 de noviembre de 2007

Fechas de registro del estudio

Enviado por primera vez

22 de noviembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

23 de noviembre de 2011

Publicado por primera vez (Estimar)

29 de noviembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

29 de noviembre de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

23 de noviembre de 2011

Última verificación

1 de noviembre de 2011

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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