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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| Adult Congenital Heart Association | UNKNOWN |
| Julie Fletcher Memorial Fund | UNKNOWN |
| Pete Huttlinger Memorial Fund |
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The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.
REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac rehabilitation | Experimental | For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. |
|
| Usual care | Active Comparator | For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac rehabilitation | Behavioral | Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation <50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities. |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily step count | Average daily step count during the intervention period measured by Fitbit 3 activity tracker | 120 days (+/- 45 days) post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 5-meter timed walk as a measure of slowness | Baseline and 120 days (+/- 45 days) post-randomization | |
| Change in exercise time as a measure of exhaustion | Exercise time on cardiopulmonary exercise testing |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome: number of participants with exercise-induced clinical ailment | Sustained arrhythmia or hemodynamic change necessitating hospitalization, heart failure hospitalization, or all-cause death within 30 days of completion of cardiac rehabilitation | 120 days (+/- 45 days) post-randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel E Clark, MD, MPH | Stanford University | Principal Investigator |
| Jonathan N Menachem, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000080039 | Univentricular Heart |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| UNKNOWN |
At enrollment, participants will be randomized in a 1:1 ratio to cardiac rehabilitation or usual care using randomly permuted blocks of 2, 4, and 6. The randomization will be stratified by study site and time from Fontan palliation.
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| Usual care | Other | For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. |
|
| Baseline and 120 days (+/- 45 days) post-randomization |
| Change in respiratory exchange ratio (RER) as a measure of exhaustion | RER on cardiopulmonary exercise testing (exhaustion) | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in mini-nutritional assessment short form (MNA-SF) score | Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in body fat percentage | Body fat percentage is a measure of body composition | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in grip strength | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in patient reported physical activity questionnaire score | The physical activity questionnaire score ranges from 0 - 10,000 kilo-calories/week, with higher scores representing higher physical activity. | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score | KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. | Baseline and 120 days (+/- 45 days) post-randomization |
| Change Patient Health Questionnaire-2 (PHQ-2) score | Mood assessment (Range 0-6, higher score indicates higher risk of depression, >=3 suggestive of depression) | Baseline and 120 days (+/- 45 days) post-randomization |
| Average daily active minutes | Total average daily active minutes from Fitbit | Baseline and 120 days (+/- 45 days) post-randomization |
| Average daily active minutes of moderate-high intensity activity | Average daily active minutes of moderate-high intensity activity from Fitbit | Baseline and 120 days (+/- 45 days) post-randomization |
| Average daily sedentary minutes | Average daily sedentary minutes from Fitbit | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in peak respiratory oxygen uptake (VO2) | Peak VO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in oxygen (O2) pulse | O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in minute ventilation/carbon dioxide production (VE/VCO2) | VE/VCO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline | Baseline and 120 days (+/- 45 days) post-randomization |
| Change in anaerobic threshold | Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline | Baseline and 120 days (+/- 45 days) post-randomization |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37240 | United States |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |