WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the Connor-Davidson Resilience Scale 10
研究概览
简要总结
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology.
There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one.
The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can:
- be delivered without any associated serious cardiac events;
- will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline.
- will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline.
- will result in increased step counts measured monthly from baseline to end of intervention
- will improve self-reported quality of life from baseline to post-intervention.
- will result in increased patient reported activity level from baseline to post-intervention
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with Fontan physiology who are 13 to <19 years of age at enrollment
- •Own a mobile device capable of installing the University of Michigan Patient Portal application
- •Fluent in English
- •Participant consent or parental/guardian consent and participant assent
排除标准
- •Height < 130 centimeters
- •Current intravenous inotropic drugs
- •Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
- •Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
- •History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms).
- •Inability to complete exercise testing at baseline screening.
- •Noncardiac medical, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
- •Suicidality or homicidality in the past 6 months.
研究组 & 干预措施
Wellness education and Home exercise programs
干预措施: WE BEAT Group Wellness Education program - phase 1 (Behavioral)
Wellness education and Home exercise programs
干预措施: HEART Club Home Exercise program - phase 2 (Behavioral)
结局指标
主要结局
Change in the Connor-Davidson Resilience Scale 10
时间窗: baseline, 6 weeks
This is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (high Resilience).
Change in the Lurz-Wilde pediatric frailty score
时间窗: baseline (prior to home exercise start), after exercise program (6 months)
The Lurz-Wilde Frailty score is the sum of points scored across 5 domains of physical and mental functioning (weakness, slowness, shrinkage, exhaustion, diminished physical activity). The maximum score is 10. If a patient accumulates \> 5 points, they are considered frail. If a patient accumulates 4-5 points, they are considered pre-frail.
次要结局
- Feasibility of the 2-phase intervention based on sociodemographic data including: self-reported race, ethnicity, household income, and education level of primary caregiver(up to approximately 18 months)
- Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled(up to approximately 18 months)
- Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention(6 months)
- Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a(baseline (prior to home exercise start), after exercise program (6 months))
- Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)(baseline (prior to home exercise start), after exercise program (6 months))
- Seven day running average step counts(baseline (week 1 of exercise program), last week of exercise program (6 months))
研究者
Jesse Hansen
Assistant Professor of Pediatrics
University of Michigan