Fontan PhysiologyNCT05543733
Home Exercise And Resiliency Training (Heart) Club
A study testing Home exercise program in people with Fontan Physiology and Frailty, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Fontan Physiology, Frailty
- What is being tested?
- Home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females with Fontan physiology
- 19 years old at age of enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
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.
Read the 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.
- Conditions
- Fontan Physiology, Frailty
- Being tested
- Home exercise program
- Keywords
- Exercise program, Liver stiffness
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise program | Experimental | Not described Receives: Behavioral: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 1 (baseline), week 26 (final visit)
Secondary outcomes (12)
Change in 7-day average step count over 6 month period
Measured: 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).
Measured: day 1 (baseline), week 26 (final visit)
Change in 6-minute walk distance
Measured: 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).
Measured: day 1 (baseline), week 26 (final visit)
Change in oxygen consumption at anaerobic threshold
This is measured during a CPET.
Measured: 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)
Measured: day 1 (baseline), week 26 (final visit)
Change in alpha fetoprotein (AFP)
This is a blood sample.
Measured: day 1 (baseline), week 26 (final visit)
Change in Aspartate Transferase (AST)
This is a blood sample.
Measured: day 1 (baseline), week 26 (final visit)
Change in Alanine Aminotransferase (ALT)
This is a blood sample.
Measured: day 1 (baseline), week 26 (final visit)
Change in platelets
This is a blood sample.
Measured: day 1 (baseline), week 26 (final visit)
Change in Gamma-glutamyl Transferase (GGT)
This is a blood sample.
Measured: day 1 (baseline), week 26 (final visit)
Change in Enhanced Liver Fibrosis (Elf) Score number
This is a blood sample.
Measured: day 1 (baseline), week 26 (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Mar 2023
- Primary completion1 Apr 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan PhysiologyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Hansen, University of Michigan
- Investigators
- Jesse Hansen, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543733
- Sponsor's protocol ID
- HUM00220044
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
- ClinicalTrials.gov ID
- NCT05543733
- Acronym / sponsor ID
- HUM00220044
- Conditions
- Fontan Physiology, Frailty
- Keywords
- Exercise program, Liver stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home exercise program | Experimental | Behavioral: Home exercise program |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females with Fontan physiology
- 19 years old at age of enrollment
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home exercise programParticipants 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. | Behavioural | Home exercise program |
Primary outcome
Change in Frailty score by the Fried frailty instrument
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).
12 secondary outcomes
Change in 7-day average step count over 6 month period
Time frame: Baseline, 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29
Time frame: day 1 (baseline), week 26 (final visit)
Change in 6-minute walk distance
Time frame: day 1 (baseline), week 26 (final visit)
Change in peak oxygen consumption
Time frame: day 1 (baseline), week 26 (final visit)
Change in oxygen consumption at anaerobic threshold
Time frame: day 1 (baseline), week 26 (final visit)
Change in liver stiffness measured by ultrasound
Time frame: day 1 (baseline), week 26 (final visit)
Change in alpha fetoprotein (AFP)
Time frame: day 1 (baseline), week 26 (final visit)
Change in Aspartate Transferase (AST)
Time frame: day 1 (baseline), week 26 (final visit)
Change in Alanine Aminotransferase (ALT)
Time frame: day 1 (baseline), week 26 (final visit)
Change in platelets
Time frame: day 1 (baseline), week 26 (final visit)
Change in Gamma-glutamyl Transferase (GGT)
Time frame: day 1 (baseline), week 26 (final visit)
Change in Enhanced Liver Fibrosis (Elf) Score number
Time frame: day 1 (baseline), week 26 (final visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Fontan Physiology
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
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Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
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Venous Compression in Fontan
Single-ventricle, Fontan Circulation
RecruitingObservational study
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Congenital Heart Surgery, Congenital Heart Disease in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Hansen, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise program in people with Fontan Physiology and Frailty, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frailty score by the Fried frailty instrument (time frame: day 1 (baseline), week 26 (final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.