Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
Overview
- Phase
- N/A
- Intervention
- Home exercise program
- Conditions
- Fontan Physiology
- Sponsor
- University of Michigan
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Change in Frailty score by the Fried frailty instrument
- Status
- Active, Not Recruiting
- Last Updated
- 24 days ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jesse Hansen
Assistant Professor of Pediatrics
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Males and females with Fontan physiology
- •19 years old at age of enrollment
Exclusion Criteria
- •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
Arms & Interventions
Home exercise program
Intervention: Home exercise program
Outcomes
Primary Outcomes
Change in Frailty score by the Fried frailty instrument
Time Frame: 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).
Secondary Outcomes
- 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))