University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT05543733
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: Baseline, 6 months
Time frame: 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).
Time frame: day 1 (baseline), week 26 (final visit)
Time frame: day 1 (baseline), week 26 (final visit)
This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).
Time frame: day 1 (baseline), week 26 (final visit)
This is measured during a CPET.
Time frame: day 1 (baseline), week 26 (final visit)
This is measured during ultrasound, units meters per second (m/sec)
Time frame: day 1 (baseline), week 26 (final visit)
This is a blood sample.
Time frame: day 1 (baseline), week 26 (final visit)
This is a blood sample.
Time frame: day 1 (baseline), week 26 (final visit)
This is a blood sample.
Time frame: day 1 (baseline), week 26 (final visit)
This is a blood sample.
Time frame: day 1 (baseline), week 26 (final visit)
This is a blood sample.
Time frame: day 1 (baseline), week 26 (final visit)
This is a blood sample.
University of Michigan
Other
Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
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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.
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