Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ontario
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Hamilton, Ontario, Canadá, L8L 2X2
- Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: home based exercise training
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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:
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. |
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Comparador Ativo: supervised exercise training
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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:
Exercise will be tracked by the participant in exercise log books. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in health-related quality of life (HRQL): Generic and disease specific
Prazo: baseline, 3 months, 6 months, one year
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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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in exercise capacity (peak exercise oxygen uptake - VO2)
Prazo: baseline, 3 months, 6 months, one year
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PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
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baseline, 3 months, 6 months, one year
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Change in self-efficacy for exercise
Prazo: baseline, 3 months, 6 months, one year
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Self-efficacy for exercise will be measured using a self-efficacy for exercise scale developed for clinicial use among cardiac patients (Ewart & Taylor, 1985)
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baseline, 3 months, 6 months, one year
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Change in caregiver burden
Prazo: baseline, 3 months, 6 months, one year
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The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
|
baseline, 3 months, 6 months, one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Heather M Arthur, PhD, Hamilton Health Sciences Corporation
- Cadeira de estudo: Robert S McKelvie, MD, PhD, Hamilton Health Sciences Corporation
- Cadeira de estudo: Jennifer Kodis, MA, Hamilton Health Scienes
- Cadeira de estudo: Kevin Thorpe, MSc, University of Toronto
- Cadeira de estudo: Catherine Demers, MD, MSc, Hamilton Health Sciences Corporation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NA 5147
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