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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home exercise program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse Hansen, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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) |