A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation
調査の概要
状態
条件
詳細な説明
OUTLINE:
Patients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
After completion of the study intervention, patients are followed for 12 months.
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：Alexi Vasbinder, PhD, RN
- 電話番号：206-221-4390
- メール：avasbind@uw.edu
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98109
- 募集
- Fred Hutch/University of Washington Cancer Consortium
-
コンタクト：
- Alexi Vasbinder, PhD, RN
- 電話番号：206-221-4390
- メール：avasbind@uw.edu
-
主任研究者：
- Alexi Vasbinder, PhD, RN
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years or older
- Ability to understand and willingness to sign a written informed consent document
- New diagnosis of acute myeloid leukemia at Fred Hutch
High-risk patients as defined by one, or more, of the following criteria:
- Age 65 years or older and/or
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and/or
CARE-BMT score ≥ 5
- Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff
- Able to exercise at low to moderate intensity, as evaluated by study staff
- Access to a mobile smart phone
- Able to read and write in English
Exclusion Criteria:
- Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
- Recurrence of AML or diagnosis of other invasive cancer
- Severe anemia (hemoglobin < 7 gm/dl)
- History of severe aortic stenosis
- New York Heart Association (NYHA) class IV heart failure
- Severe pain with basic movement
- Pregnant persons
- Unable to give consent
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Supportive Care (CAREFit-BMT exercise program)
Patients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity.
Patients also undergo blood sample collection throughout the study.
|
採血を受ける
他の名前：
補助研究
補助研究
補助研究
Undergo moderate-intensity aerobic exercises
他の名前：
Undergo strength training
他の名前：
|
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 |
|---|---|---|
|
Recruitment rates (Feasibility)
時間枠：Up to 24 months
|
Recruitment will be calculated as the proportion of eligible patients who provide informed consent, with 95% confidence intervals, and reasons for ineligibility or refusal summarized from screening logs.
|
Up to 24 months
|
|
Retention rates (Feasibility)
時間枠：Up to 24 months
|
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment, also with 95% confidence intervals.
|
Up to 24 months
|
|
Adherence to program (Feasibility)
時間枠：At the end of the CAREFit-BMT program (Day 85)
|
Adherence will be evaluated from both aerobic and resistance training participation, including the percentage of prescribed sessions completed and average weekly minutes of moderate-intensity aerobic activity from wearable device data.
|
At the end of the CAREFit-BMT program (Day 85)
|
|
Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score
時間枠：At the end of the CAREFit-BMT program (Day 85)
|
Acceptability will be assessed using validated instrument, Acceptability of Intervention Measure, summarized as means with standard deviations.
Scores range from 1 to 5, with higher scores indicating greater acceptability.
|
At the end of the CAREFit-BMT program (Day 85)
|
|
Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score
時間枠：At the end of the CAREFit-BMT program (Day 85)
|
Will be assessed using validated instrument, Intervention Appropriateness Measure, summarized as means with standard deviations.
Scores range from 1 to 5, with higher scores indicating greater appropriateness.
|
At the end of the CAREFit-BMT program (Day 85)
|
|
Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score
時間枠：At the end of the CAREFit-BMT program (Day 85)
|
Will be assessed using validated instrument, Feasibility of Intervention Measure, summarized as means with standard deviations.
Scores range from 1 to 5, with higher scores indicating greater feasibility.
|
At the end of the CAREFit-BMT program (Day 85)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
時間枠：At the end of the CAREFit-BMT program (Day 85)
|
Participant-specific barriers and facilitators to enrollment, participation, and adherence, will be assessed through semi-structured qualitative interviews informed by the Capability, Opportunity, Motivation, and Behavior (COM-B) framework.
|
At the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be measured by cardiopulmonary exercise testing to assess anaerobic threshold. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak)
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be measured by cardiopulmonary exercise testing to assess peak oxygen consumption (VO₂peak). Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be measured by cardiopulmonary exercise testing to assess VO₂peak percent-predicted. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in Respiratory exchange ratio at peak
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be measured by cardiopulmonary exercise testing to assess respiratory exchange ratio at peak. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in Minute ventilation/carbon dioxide production (VE/VCO₂) slope
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be measured by cardiopulmonary exercise testing to assess minute ventilation/carbon dioxide production (VE/VCO₂) slope. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiovascular (CV) symptoms
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be measured using the Kansas City Cardiomyopathy Questionnaire-12.
Standardized scores range from 0-100, with higher scores indicating better outcome.
|
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in CV biomarkers
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will include cardiac troponins (I & T), NT-pro-BNP, and IL-6 measured in collected blood samples through University of Washington Research Testing Service.
|
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in quality of life
時間枠：Baseline up to the end of the CAREFit-BMT program (Day 85)
|
Will be assessed using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire.
Total scores range from 0-148, with higher scores indicating better outcome.
|
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Alexi Vasbinder, PhD, RN、Fred Hutch/University of Washington Cancer Consortium
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
- RG1125934
- KL2TR002317 (米国 NIH グラント/契約)
- NCI-2026-03252 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- FHIRB0021306 (その他の識別子：Fred Hutch/University of Washington Cancer Consortium)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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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