Home Exercise and Resiliency Training (Heart) Club
- Conditions
- FrailtyFontan Physiology
- Interventions
- Behavioral: Home exercise program
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 53
- Males and females with Fontan physiology
- 19 years old at age of enrollment
- 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
- Arm && Interventions
Group Intervention Description Home exercise program Home exercise program -
- 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 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 6-minute walk distance day 1 (baseline), week 26 (final visit) 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