Home Exercise And Resiliency Training (Heart) Club

Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Frailty; Fontan Physiology
• Intervention / Treatment: Behavioral: Home exercise program

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 Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home exercise program

Behavioral: Home exercise program; Participants will complete a 6-month prescription telemedicine-based structured home exercise program. Baseline information will be used to develop a personalized home exercise program. This program will involve downloading the MyDataHelps application on a mobile device to securely collect wearable device information like step counts, activity minutes, and heart rate. Additionally, participants will have multiple virtual visits as well as the 2 in-person visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frailty score by the Fried frailty instrument	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).	day 1 (baseline), week 26 (final visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 7-day average step count over 6 month period		Baseline, 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	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).	day 1 (baseline), week 26 (final visit)
Change in 6-minute walk distance		day 1 (baseline), week 26 (final visit)
Change in peak oxygen consumption	This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).	day 1 (baseline), week 26 (final visit)
Change in oxygen consumption at anaerobic threshold	This is measured during a CPET.	day 1 (baseline), week 26 (final visit)
Change in liver stiffness measured by ultrasound	This is measured during ultrasound, units meters per second (m/sec)	day 1 (baseline), week 26 (final visit)
Change in alpha fetoprotein (AFP)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Change in Aspartate Transferase (AST)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Change in Alanine Aminotransferase (ALT)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Change in platelets	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Change in Gamma-glutamyl Transferase (GGT)	This is a blood sample.	day 1 (baseline), week 26 (final visit)
Change in Enhanced Liver Fibrosis (Elf) Score number	This is a blood sample.	day 1 (baseline), week 26 (final visit)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Jesse Hansen, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 1, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise program; Liver stiffness
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: HUM00220044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No