Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06150950

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.

1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Single-ventricle Univentricular Heart

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

Loading trial locations.

About this study

REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF <50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 < 50% predicted (by FRIEND equation)
  • Age >= 18 years old

Exclusion criteria

  • Inotrope-dependence
  • Symptomatic, uncontrolled arrhythmias
  • Pregnancy
  • Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
  • Inability to comply with the protocol
  • Recent (<3 months) planned Fontan pathway percutaneous or surgical intervention
  • Resting hypoxemia with baseline oxygen saturation <80%

Treatment and study plan

Cardiac rehabilitation

Behavioral

Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation <50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.

Usual Care

Other

For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians.

Primary outcomes

  1. Average daily step count

    Time frame: 120 days (+/- 45 days) post-randomization

    Average daily step count during the intervention period measured by Fitbit 3 activity tracker

Secondary outcomes

  1. Change in 5-meter timed walk as a measure of slowness

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

  2. Change in exercise time as a measure of exhaustion

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Exercise time on cardiopulmonary exercise testing

  3. Change in respiratory exchange ratio (RER) as a measure of exhaustion

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    RER on cardiopulmonary exercise testing (exhaustion)

  4. Change in mini-nutritional assessment short form (MNA-SF) score

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status

  5. Change in body fat percentage

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Body fat percentage is a measure of body composition

  6. Change in grip strength

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

  7. Change in patient reported physical activity questionnaire score

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    The physical activity questionnaire score ranges from 0 - 10,000 kilo-calories/week, with higher scores representing higher physical activity.

  8. Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement.

  9. Change Patient Health Questionnaire-2 (PHQ-2) score

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Mood assessment (Range 0-6, higher score indicates higher risk of depression, >=3 suggestive of depression)

  10. Average daily active minutes

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Total average daily active minutes from Fitbit

  11. Average daily active minutes of moderate-high intensity activity

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Average daily active minutes of moderate-high intensity activity from Fitbit

  12. Average daily sedentary minutes

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Average daily sedentary minutes from Fitbit

  13. Change in peak respiratory oxygen uptake (VO2)

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Peak VO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline

  14. Change in oxygen (O2) pulse

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline

  15. Change in minute ventilation/carbon dioxide production (VE/VCO2)

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    VE/VCO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline

  16. Change in anaerobic threshold

    Time frame: Baseline and 120 days (+/- 45 days) post-randomization

    Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline

Other outcomes

  1. Exploratory outcome: number of participants with exercise-induced clinical ailment

    Time frame: 120 days (+/- 45 days) post-randomization

    Sustained arrhythmia or hemodynamic change necessitating hospitalization, heart failure hospitalization, or all-cause death within 30 days of completion of cardiac rehabilitation

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Adult Congenital Heart Association
  • Julie Fletcher Memorial Fund
  • Pete Huttlinger Memorial Fund
  • Vanderbilt University Medical Center

Registry information

Official study title

RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 30, 2023
Registry last updated
Jan 5, 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.

Related clinical trials

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