Clinical trial NCT05543733: Home Exercise And Resiliency Training (Heart) Club
Official title: Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fontan Physiology
Frailty
Keywords: Exercise program
Liver stiffness
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Frailty score by the Fried frailty instrument
timeFrame: day 1 (baseline), week 26 (final visit)
Secondary outcomes:
measure: Change in 7-day average step count over 6 month period
timeFrame: Baseline, 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in 6-minute walk distance
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in peak oxygen consumption
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in oxygen consumption at anaerobic threshold
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in liver stiffness measured by ultrasound
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in alpha fetoprotein (AFP)
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in Aspartate Transferase (AST)
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in Alanine Aminotransferase (ALT)
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in platelets
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in Gamma-glutamyl Transferase (GGT)
timeFrame: day 1 (baseline), week 26 (final visit)
measure: Change in Enhanced Liver Fibrosis (Elf) Score number
timeFrame: day 1 (baseline), week 26 (final visit)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jesse Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: