Skip to main content
OpenTrials
Completed

NCT Number: NCT05543733

Home Exercise And Resiliency Training (Heart) Club

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Exercise Program

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in 7-day average step count over 6 month period

    Time frame: Baseline, 6 months

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    Time frame: 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).

  3. Change in 6-minute walk distance

    Time frame: day 1 (baseline), week 26 (final visit)

  4. Change in peak oxygen consumption

    Time frame: day 1 (baseline), week 26 (final visit)

    This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).

  5. Change in oxygen consumption at anaerobic threshold

    Time frame: day 1 (baseline), week 26 (final visit)

    This is measured during a CPET.

  6. Change in liver stiffness measured by ultrasound

    Time frame: day 1 (baseline), week 26 (final visit)

    This is measured during ultrasound, units meters per second (m/sec)

  7. Change in alpha fetoprotein (AFP)

    Time frame: day 1 (baseline), week 26 (final visit)

    This is a blood sample.

  8. Change in Aspartate Transferase (AST)

    Time frame: day 1 (baseline), week 26 (final visit)

    This is a blood sample.

  9. Change in Alanine Aminotransferase (ALT)

    Time frame: day 1 (baseline), week 26 (final visit)

    This is a blood sample.

  10. Change in platelets

    Time frame: day 1 (baseline), week 26 (final visit)

    This is a blood sample.

  11. Change in Gamma-glutamyl Transferase (GGT)

    Time frame: day 1 (baseline), week 26 (final visit)

    This is a blood sample.

  12. Change in Enhanced Liver Fibrosis (Elf) Score number

    Time frame: day 1 (baseline), week 26 (final visit)

    This is a blood sample.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.