Accelerated (Intensive) Cardiac Training for Heart Failure Patients (ACT-HF)
Accelerated (Intensive) Cardiac Training for Heart Failure Patients (ACT-HF)
The purpose of this study is to see if patients undergoing accelerated Intensive Cardiac Rehabilitation (ICR) (2 weeks after discharge) will improve exercise performance as well as on measures of quality of life after a cardiac hospitalization.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The goal of this study is to evaluate the safety and effectiveness of initiating ICR (Intensive Cardiac Rehabilitation) at 2 weeks versus 6 weeks following hospital discharge in patients with HFrEF (Heart Failure with reduced Ejection Fraction). This is a randomized, controlled trial with two parallel groups. The Early Intervention Group with ICR initiated 2 weeks ±2 weeks following hospital discharge and the Usual Care Group with ICR initiated 6 weeks ±2 weeks after hospital discharge. Potential participants will be identified at Missouri Baptist Medical Center and referred for ICR at the HCI (Heart Care Institute) at Barnes Jewish West County Hospital (BJWCH). This study is being funded by the Missouri Baptist Healthcare Foundation.
To be evaluable, participants must complete a minimum of 24 ICR days, scheduled up to three days per week, with the option of completing a maximum of 36 ICR days over a period of up to 12-to-15-weeks post hospital discharge. The study team will analyze the ICR data from the start of ICR through 24 days of ICR. Data after 24 days will only include information on whether a participant continues to complete the maximum 36 days of ICR. During the trial, participants will complete performance tests and PRO (Participant Reported Outcome) surveys and questionnaires. Performance tests include a 6MWT (six minute walk test), a SPPB test (Short Performance Battery Test), and a handgrip test and will be completed at baseline, and the start of ICR and at the end of the completion of the 24th day of ICR.
PROs include a Cardiac Self-Efficacy Questionnaire (survey), Dartmouth COOP General Health Questionnaire (survey), PHQ-9 (survey), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Beck Depression Score (BDS), Rate Your Plate (RYP) and Duke Activity Status Index (DASI). PROs will be completed during baseline, start of ICR, and at the end of the 24th day of ICR.
The Early Intervention Group will repeat performance assessments and PROs 6-weeks (approximately 4-weeks post ICR start-up) following hospital discharge.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Dawson Haley A Haley, B.S.
- Número de telefone: 314-362-8941
- E-mail: dhaley@wustl.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age ≥ 18 years of age at the time of consent
- Diagnosis of HFrEF
- EF <35% within 3 months of hospital discharge
- Current hospitalization for a cardiac event (an approved cardiac diagnosis, such as chronic angina, recent MI (heart attack), cardiac surgery, or recent percutaneous coronary intervention (PCI) e.g., stent placement)
- Agreeable to complete 24 days of ICR and study requirements
- Ability and willingness to sign the ICF
- Referred to intensive cardiac rehabilitation at Washington University Heart Care Institute (HCI) at Barnes-Jewish West County Hospital (BJWCH).
Exclusion Criteria:
- Diagnosis of dementia
- Significant orthopedic limitations (e.g., double amputee) (walking with a walker is acceptable)
- Discharge to rehab facility or nursing home
- Pregnant women
- Currently enrolled in Hospice, not expected to live for 12 months
- Undergoing treatment for any type of cancer other than skin cancer
- History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to participants or interfere with study procedures, evaluation, or completion.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 2 weeks post discharge group
Participants will be randomized into a 2 week post discharge group that will start cardiac rehabilitation 2 weeks after discharge compared to normal SOC at 6 weeks post discharge. |
Patients will be early referred (2 wks vs 6wks) to cardiac rehabilitation to see if there are benefits to early referral. |
|
Comparador de Placebo: 6 weeks post discharge group (SOC)
Participants will be randomized into the SOC 6 week post discharge group. |
Normal Standard of care 6 week referral time. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety and Tolerability of Accelerated ICR 2 weeks and 6 weeks post-hospital discharge
Prazo: From enrollment, to completion of at least 24 cardiac rehabilitation days.
|
To evaluate safety/tolerability of accelerated ICR beginning 2 weeks post-hospital discharge compared to usual standard care ICR beginning 6 weeks post-hospital discharge in patients with HFrEF. Safety will be determined by incidence of adverse events from randomization through 24 days after ICR initiation. Tolerability will be measured by number of ICR days attended (out of the required 24 ICR days). |
From enrollment, to completion of at least 24 cardiac rehabilitation days.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in exercise performance in six minute walk test. |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in exercise performance in Short Performance Battery Test. |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in exercise performance in handgrip dynamometer test. |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in Patient Reported Outcomes (PROs): Cardiac Self-Efficacy Questionnaire. |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in Patient Reported Outcomes (PROs): Dartmouth COOP General Health Questionnaire |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in Patient Reported Outcomes (PROs): Minnesota Living with Heart Failure Questionnaire (MLHFQ) |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in Patient Reported Outcomes (PROs): Beck Depression Score (BDS) |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in Patient Reported Outcomes (PROs): Rate Your Plate (RYP) |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Prazo: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days: • Changes in Patient Reported Outcomes (PROs): Duke Activity Status Index (DASI) |
From enrollment, to at least the completion of 24 cardiac rehabilitation days.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Rehospitalization and All- Cause Morality within 6 Months Post-Hospital Discharge
Prazo: Enrollment to within 6 months post-hospital discharge
|
To evaluate rehospitalization and all-cause mortality within 6 months post-hospital discharge for HFrEF patients enrolled in early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge).I ncidence of rehospitalization and, all-cause mortality and deaths from randomization through the 6-month follow up phone call. |
Enrollment to within 6 months post-hospital discharge
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Linda R Peterson, M.D., Washington University School of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202603003
- GR0041819 (Número de outro subsídio/financiamento: Missouri Baptist Healthcare Foundation)
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