Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Frailty score by the Fried frailty instrument
研究概览
简要总结
The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.
详细描述
This study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. Visit one will require participants to complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. The second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with Fontan physiology
- •19 years old at age of enrollment
排除标准
- •Height less than 130 centimeter (cm)
- •Pregnancy or the plan to become pregnant during the study period
- •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, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results
研究组 & 干预措施
Home exercise program
干预措施: Home exercise program (Behavioral)
结局指标
主要结局
Change in Frailty score by the Fried frailty instrument
时间窗: day 1 (baseline), week 26 (final visit)
The questionnaire evaluates five components of the frailty syndrome (weakness, slowness, shrinkage, exhaustion, and diminished physical activity). Sum of the components will have a possible score of 0-5: not frail (score 0), pre-frail (score 1-2), frail (score great or equal to 3), undetermined (missing component).
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29(day 1 (baseline), week 26 (final visit))
- Change in 6-minute walk distance(day 1 (baseline), week 26 (final visit))
- Change in Aspartate Transferase (AST)(day 1 (baseline), week 26 (final visit))
- Change in Alanine Aminotransferase (ALT)(day 1 (baseline), week 26 (final visit))
- Change in platelets(day 1 (baseline), week 26 (final visit))
- Change in 7-day average step count over 6 month period(Baseline, 6 months)
- Change in peak oxygen consumption(day 1 (baseline), week 26 (final visit))
- Change in alpha fetoprotein (AFP)(day 1 (baseline), week 26 (final visit))
- Change in oxygen consumption at anaerobic threshold(day 1 (baseline), week 26 (final visit))
- Change in Enhanced Liver Fibrosis (Elf) Score number(day 1 (baseline), week 26 (final visit))
- Change in liver stiffness measured by ultrasound(day 1 (baseline), week 26 (final visit))
- Change in Gamma-glutamyl Transferase (GGT)(day 1 (baseline), week 26 (final visit))
研究者
Jesse Hansen
Assistant Professor of Pediatrics
University of Michigan