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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dawson Haley A Haley, B.S.
- 電話番号：314-362-8941
- メール：dhaley@wustl.edu
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and Tolerability of Accelerated ICR 2 weeks and 6 weeks post-hospital discharge
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Efficacy of enrollment rates in Cardiac Rehabilitation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rehospitalization and All- Cause Morality within 6 Months Post-Hospital Discharge
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Linda R Peterson, M.D.、Washington University School of Medicine
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 202603003
- GR0041819 (その他の助成金/資金番号：Missouri Baptist Healthcare Foundation)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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