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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Dawson Haley A Haley, B.S.
- Номер телефона: 314-362-8941
- Электронная почта: dhaley@wustl.edu
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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. |
|
Плацебо Компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Safety and Tolerability of Accelerated ICR 2 weeks and 6 weeks post-hospital discharge
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rehospitalization and All- Cause Morality within 6 Months Post-Hospital Discharge
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Linda R Peterson, M.D., Washington University School of Medicine
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 202603003
- GR0041819 (Другой номер гранта/финансирования: Missouri Baptist Healthcare Foundation)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .