Fontan Physiology, Frailty
Conditions
Keywords
Exercise program, Liver stiffness
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.
Interventions
BEHAVIORALHome 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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in 7-day average step count over 6 month period | Baseline, 6 months | — |
| 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 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 oxygen consumption at anaerobic threshold | day 1 (baseline), week 26 (final visit) | This is measured during a CPET. |
| 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 alpha fetoprotein (AFP) | day 1 (baseline), week 26 (final visit) | This is a blood sample. |
| 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 Gamma-glutamyl Transferase (GGT) | day 1 (baseline), week 26 (final visit) | This is a blood sample. |
| Change in Enhanced Liver Fibrosis (Elf) Score number | day 1 (baseline), week 26 (final visit) | This is a blood sample. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJesse Hansen, MD
University of Michigan
Outcome results
None listed