At-Home Cardiac Rehabilitation for Adolescents At Risk for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Average change in triglyceride level as measured from baseline to 6 months.
研究概览
简要总结
The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are
- To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.
- To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance.
- To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications.
- Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA.
Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged of 10-21 years at enrollment
- •Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
- •History of anthracycline exposure +/- radiation
- •Currently in remission, with at least 6 months off chemotherapy
- •Able to perform CPET
- •Baseline CPET with VO2 <80% (at start of study, or CPET at CHLA after January 2020)
- •Smartphone compatible with Fitbit (own or parent/legal guardian's)
- •Ability to complete and send diary and Fitbit information on a weekly basis
- •Ability to participate in monthly virtual check-in visits
- •Baseline activity prior to intervention <30min/day, 2x/week
排除标准
- •Inability to obtain consent/assent
- •Unable to accurately perform quality of life survey independently
- •No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery
- •Contraindication to moderate activity (>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D)
- •Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
- •Unable to perform mild activity for at least 0.5h/day and at least 2x/week
- •Unable to come to hospital for study visits at 0 and 6 months
- •Unable to complete study-related surveys
- •Unable to complete and send diary and Fitbit information on a weekly basis
- •Unable to check-in monthly on virtual platform
- •On beta blockade
- •Pregnancy
研究组 & 干预措施
Treatment Arm
干预措施: Cardio-oncology rehabilitation (Behavioral)
结局指标
主要结局
Average change in triglyceride level as measured from baseline to 6 months.
时间窗: Baseline to 6 months
Triglyceride (mg/dL) will be measured.
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
时间窗: Baseline to 6 months
Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.
Average change in total cholesterol level as measured from baseline to 6 months.
时间窗: Baseline to 6 months
Total cholesterol (mg/dL) will be measured.
Change in cardiac function after completion of a 6-month exercise intervention.
时间窗: Baseline to 6 months
Cardiac function will be assessed via echocardiogram.
Change in cardiac rhythm after completion of a 6-month exercise intervention.
时间窗: Baseline to 6 months
Cardiac rhythm will be assessed via EKG.
Change in cardiac stress after completion of a 6-month exercise intervention.
时间窗: Baseline to 6 months
Cardiac stress will be assessed via NT-proBNP level.
Average change in high density lipoprotein level as measured from baseline to 6 months.
时间窗: Baseline to 6 months
High density lipoprotein (HDL) (mg/dL) will be measured.
Average change in very low density lipoprotein as measured from baseline to 6 months.
时间窗: Baseline to 6 months
Very low density lipoprotein (VLDL) (mg/dL) will be measured.
Average change in low density lipoprotein as measured from baseline to 6 months.
时间窗: Baseline to 6 months
Low density lipoprotein (LDL) (mg/dL) will be measured.
次要结局
- Average change in reported quality of life from baseline to 6 months(Baseline to 6 months)
- Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months(Baseline to 6 months)
- Average change in activity level from baseline to 6 months(Baseline to 6 months)
研究者
Jennifer Su
Assistant Professor, Keck School of Medicine, University of Southern California
Children's Hospital Los Angeles