Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
研究概览
简要总结
To assess the feasibility and preliminary effectiveness of a Cardio-Oncology Prehabilitation program in patients at high-risk of developing Cardiovascular (CV) events in improving Cardiorespiratory fitness (CRF) and reducing acute CV complications in Hematopoietic stem cell transplant (HSCT) recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years or older
- •Referred for HSCT evaluation
- •Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia, atrial fibrillation, obesity, heart failure, history of coronary artery disease, diabetes)
- •Able to ambulate unassisted
- •Ability to understand and the willingness to sign a written informed consent
- •Ability to use Polar Flow heart rate application
排除标准
- •Severe anemia (hemoglobin <7 gm/dl)
- •Untreated high-risk coronary artery disease (left main, triple vessel disease)
- •Severe aortic stenosis
- •Recent fracture as assessed via self-report
- •Gross balance deficits
- •Severe pain with basic movement
- •Unable to ambulate unassisted or exercise
- •NYHA class IV heart failure
- •Adults unable to give consent, pregnant women, and prisoners are excluded from this study.
研究组 & 干预措施
Cardio-oncology program
The cardio-oncology program consists of a multimodal approach, which includes individualized exercise prescription following a detailed CV assessment and medical management of CV risk factors occurring over 8 weeks.
干预措施: Cardio-oncology program (Other)
结局指标
主要结局
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
时间窗: 8 weeks post enrollment
The percentage of days of exercised out of 24 days recommended over the 8 weeks for both aerobic and resistance activities.
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in VO2peak).
时间窗: 8 weeks post enrollment
change in VO2peak from pre to post intervention reported in ml/kg/min
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
时间窗: 8 weeks post enrollment
the number of participants recruited per month
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).
时间窗: 8 weeks post enrollment
the average amount of time required for participants to complete initial and follow-up CV assessments
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction).
时间窗: 8 weeks post enrollment
Assessed qualitatively with in-depth, semi-structured, one-to-one exit interviews with participants. A member of the research team experienced with telephone interviews, but not involved in intervention delivery, will contact all patients within 1 week after completion of the final follow-up assessment.The researcher will facilitate the interviews using a conversational-style approach whilst referring to a topic guide. Topics will focus on patients' perceived expectations, benefits, motives, and barriers to the program. The researcher will additionally ask questions regarding reasons for non-adherence to the exercise intervention, and reasons for dropout amongst discontinuing patients. The topic guide will be used flexibly to allow patients to raise additional issues which they consider important to the study. Interviews will be recorded with participants knowledge and then transcribed, coded, and assessed for relevant themes and recommendations using iterative thematic analysis
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in anaerobic threshold).
时间窗: 8 weeks post enrollment
change in anaerobic threshold from pre to post intervention reported in L/min
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).
时间窗: 8 weeks post enrollment
percentage of enrolled participants who complete pre-post CV assessments
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).
时间窗: 8 weeks post enrollment
The average duration (min) of aerobic and resistance workouts over the course of the intervention.
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
时间窗: 8 weeks post enrollment
Percent of eligible participants who are screened and give informed consent
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data).
时间窗: 8 weeks post enrollment
the percentage of missing data from study questionnaires.
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER).
时间窗: 8 weeks post enrollment
change in RER (a ratio between cardiac dioxide output (VCO2)/oxygen uptake (VO2)) from pre to post intervention reported as the percent difference between the values
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (comparison of V02 peak to predicted).
时间窗: 8 weeks post enrollment
Comparison of V02 peak assessed after intervention in comparison to the predicted values reported as the percent difference between the values
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (VE/VC02 slope).
时间窗: 8 weeks post enrollment
Change in VE/VC02 slope (defined as the change in minute ventilation per unit of carbon dioxide production) from pre to post intervention
次要结局
- Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.(8 weeks post enrollment)
- Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program(8 weeks post enrollment)
- Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program(8 weeks post enrollment)
- Difference in biomarkers after an 8-week cardio-oncology prehabilitation program(8 weeks post enrollment)