Home Exercise And Resiliency Training (Heart) Club
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home exercise program
|
Behavioral: Home 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females with Fontan physiology
-
18 years old at enrollment
Exclusion Criteria:
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Height less than 130 centimeter (cm)
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Pregnancy or the plan to become pregnant during the study period
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Current intravenous inotropic drugs
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Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment
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Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment
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History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms)
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Inability to complete exercise testing at baseline screening
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Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Jesse Hansen, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00220044