Home Exercise and Resiliency Training (Heart) Club

Not Applicable

Recruiting

• Conditions: Frailty; Fontan Physiology

• Registration Number: NCT05543733
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Study Start: 2023-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Frailty score by the Fried frailty instrument	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 Outcome Measures

Name	Time	Method
Change in 6-minute walk distance	day 1 (baseline), week 26 (final visit)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	day 1 (baseline), week 26 (final visit)	This survey has 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Change in Aspartate Transferase (AST)	day 1 (baseline), week 26 (final visit)	This is a blood sample.
Change in Alanine Aminotransferase (ALT)	day 1 (baseline), week 26 (final visit)	This is a blood sample.
Change in platelets	day 1 (baseline), week 26 (final visit)	This is a blood sample.
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)	This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).
Change in alpha fetoprotein (AFP)	day 1 (baseline), week 26 (final visit)	This is a blood sample.
Change in oxygen consumption at anaerobic threshold	day 1 (baseline), week 26 (final visit)	This is measured during a CPET.
Change in Enhanced Liver Fibrosis (Elf) Score number	day 1 (baseline), week 26 (final visit)	This is a blood sample.
Change in liver stiffness measured by ultrasound	day 1 (baseline), week 26 (final visit)	This is measured during ultrasound, units meters per second (m/sec)
Change in Gamma-glutamyl Transferase (GGT)	day 1 (baseline), week 26 (final visit)	This is a blood sample.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States