Fontan PhysiologyNCT05199857
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
A study testing WE BEAT Group Wellness Education program - phase 1 and HEART Club Home Exercise program - phase 2 in people with Fontan Physiology and Frailty, run by University of Michigan at 1 site in United States.
Trial summary
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Fontan Physiology, Frailty, Single Ventricle Heart Disease
- What is being tested?
- WE BEAT Group Wellness Education program - phase 1 and HEART Club Home Exercise program - phase 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 1 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females with Fontan physiology who are 13 to <19 years of age at enrollment
- Own a mobile device capable of installing the University of Michigan Patient Portal application
- Fluent in English
- Participant consent or parental/guardian consent and participant assent
Who cannot join
- Height < 130 centimeters
- 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, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
- Suicidality or homicidality in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology.
There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one.
Read more
The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can:
- be delivered without any associated serious cardiac events;
- will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline.
- will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline.
- will result in increased step counts measured monthly from baseline to end of intervention
- will improve self-reported quality of life from baseline to post-intervention.
- will result in increased patient reported activity level from baseline to post-intervention
- Conditions
- Fontan Physiology, Frailty, Single Ventricle Heart Disease
- Being tested
- WE BEAT Group Wellness Education program - phase 1, HEART Club Home Exercise program - phase 2
- Keywords
- Wellness education, Exercise program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE BEAT Group Wellness Education program - phase 1Behavioural
Participants will be assigned into a small group with 3-6 other participants and will participate in a weekly, 45-50 minute intervention session for 5 weeks, delivered by a licensed clinical psychologist or limited licensed clinical psychology fellow using University of Michigan (UM) Zoom. Each session will focus on a particular skill related to wellness and resiliency. There will also be a short battery of questionnaires to complete.
HEART Club Home Exercise program - phase 2Behavioural
This is an individualized home exercise program adapted from the exercise programs used in traditional, hospital-based cardiac rehabilitation. A complete cardiopulmonary exercise test (CPET) may be completed if needed for a baseline and one will be done at the last visit. The exercise physiology team will discuss participants exercise goals, interests, and available resources to help develop the exercise plan for the research study. Once the program is designed, participants will complete the exercise activities in the plan. Over time, participants will advance through various stages in the program and then will be gradually introduced to the principles of exercise rehabilitation and more intense physical exercise. Participants will be asked to wear a wearable activity tracker and have scheduled video check-ins with the exercise physiology team. Throughout the program participants will complete a short battery of surveys.
| Study group | Role | What they receive |
|---|---|---|
| Wellness education and Home exercise programs | Experimental | Not described Receives: Behavioral: WE BEAT Group Wellness Education program - phase 1; Behavioral: HEART Club Home Exercise program - phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Connor-Davidson Resilience Scale 10
This is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (high Resilience).
Measured: baseline, 6 weeks
Change in the Lurz-Wilde pediatric frailty score
The Lurz-Wilde Frailty score is the sum of points scored across 5 domains of physical and mental functioning (weakness, slowness, shrinkage, exhaustion, diminished physical activity). The maximum score is 10. If a patient accumulates > 5 points, they are considered frail. If a patient accumulates 4-5 points, they are considered pre-frail.
Measured: baseline (prior to home exercise start), after exercise program (6 months)
Secondary outcomes (6)
Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled
Measured: up to approximately 18 months
Feasibility of the 2-phase intervention based on sociodemographic data including: self-reported race, ethnicity, household income, and education level of primary caregiver
Measured: up to approximately 18 months
Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention
- Not related: Accidents and injuries not related to exercise prescription, illnesses not attributed to cardiovascular status, Cardiac events that are not temporally related to prescribed exercise sessions
- Possibly: Musculoskeletal complaints consistent with overuse or repetitive stress injury with a mechanism that is not consistent with the prescribed of exercise, Cardiac events/symptoms that occur between 90 to180 minutes after exercise
- Probably: Musculoskeletal complaints consistent with overuse or repetitive stress injury that are consistent with the prescribed mechanism of exercise, Cardiac events/symptoms that occur between 15 minutes to 90 minutes after prescribed exercise
- Definitely: Accidents or injuries that occur during prescribed exercise, Cardiac events/symptoms that occur during or up to 15 minutes after prescribed exercise
Measured: 6 months
Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a
This is a 4-item questionnaire that asks participants about their level of physical activity in the past 7 days. Items are scored on a 5-point scale. Scores range from 4 to 20 with 4 indicating low physical activity and 20 indicating high physical activity (better outcome).
Measured: baseline (prior to home exercise start), after exercise program (6 months)
Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)
PROMIS-25 measures quality of life (i.e., depression, anxiety, and pain interference). The 25 items are on a 1-5 scale and are scored using the Health Measures Scoring Service with higher scores indicating a lower quality of life.
Measured: baseline (prior to home exercise start), after exercise program (6 months)
Seven day running average step counts
Measured: baseline (week 1 of exercise program), last week of exercise program (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start30 Mar 2022
- Primary completion1 Apr 2026
- Study completion1 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Reuben Phoenix Schostak Fontan Wellness Project Fund
- 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
- NCT05199857
- Sponsor's protocol ID
- HUM00205931
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 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
- WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
- ClinicalTrials.gov ID
- NCT05199857
- Acronym / sponsor ID
- HUM00205931
- Conditions
- Fontan Physiology, Frailty, Single Ventricle Heart Disease
- Keywords
- Wellness education, Exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Reuben Phoenix Schostak Fontan Wellness Project Fund
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 20 Jan 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.
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology.
There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one.
The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can:
- be delivered without any associated serious cardiac events;
- will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline.
- will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline.
- will result in increased step counts measured monthly from baseline to end of intervention
- will improve self-reported quality of life from baseline to post-intervention.
- will result in increased patient reported activity level from baseline to post-intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness education and Home exercise programs | Experimental | Behavioral: WE BEAT Group Wellness Education program - phase 1, Behavioral: HEART Club Home Exercise program - phase 2 |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males and females with Fontan physiology who are 13 to <19 years of age at enrollment
- Own a mobile device capable of installing the University of Michigan Patient Portal application
- Fluent in English
- Participant consent or parental/guardian consent and participant assent
Key exclusion criteria (8 listed)
- Height < 130 centimeters
- 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).
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 |
|---|---|---|
| WE BEAT Group Wellness Education program - phase 1Participants will be assigned into a small group with 3-6 other participants and will participate in a weekly, 45-50 minute intervention session for 5 weeks, delivered by a licensed clinical psychologist or limited licensed clinical psychology fellow using University of Michigan (UM) Zoom. Each session will focus on a particular skill related to wellness and resiliency. There will also be a short battery of questionnaires to complete. | Behavioural | Wellness education and Home exercise programs |
| HEART Club Home Exercise program - phase 2This is an individualized home exercise program adapted from the exercise programs used in traditional, hospital-based cardiac rehabilitation. A complete cardiopulmonary exercise test (CPET) may be completed if needed for a baseline and one will be done at the last visit. The exercise physiology team will discuss participants exercise goals, interests, and available resources to help develop the exercise plan for the research study. Once the program is designed, participants will complete the exercise activities in the plan. Over time, participants will advance through various stages in the program and then will be gradually introduced to the principles of exercise rehabilitation and more intense physical exercise. Participants will be asked to wear a wearable activity tracker and have scheduled video check-ins with the exercise physiology team. Throughout the program participants will complete a short battery of surveys. | Behavioural | Wellness education and Home exercise programs |
Primary outcome
Change in the Connor-Davidson Resilience Scale 10
Time frame: baseline, 6 weeks
This is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (high Resilience).
Change in the Lurz-Wilde pediatric frailty score
Time frame: baseline (prior to home exercise start), after exercise program (6 months)
The Lurz-Wilde Frailty score is the sum of points scored across 5 domains of physical and mental functioning (weakness, slowness, shrinkage, exhaustion, diminished physical activity). The maximum score is 10. If a patient accumulates > 5 points, they are considered frail. If a patient accumulates 4-5 points, they are considered pre-frail.
6 secondary outcomes
Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled
Time frame: up to approximately 18 months
Feasibility of the 2-phase intervention based on sociodemographic data including: self-reported race, ethnicity, household income, and education level of primary caregiver
Time frame: up to approximately 18 months
Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention
Time frame: 6 months
Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a
Time frame: baseline (prior to home exercise start), after exercise program (6 months)
Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)
Time frame: baseline (prior to home exercise start), after exercise program (6 months)
Seven day running average step counts
Time frame: baseline (week 1 of exercise program), last week of exercise program (6 months)
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.
Fontan Procedure, Fontan Circulation
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
Recruiting
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 WE BEAT Group Wellness Education program - phase 1 and HEART Club Home Exercise program - phase 2 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 4 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 the Connor-Davidson Resilience Scale 10 (time frame: baseline, 6 weeks). The study lists 2 primary outcomes in all. 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.