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. 1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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.
Stanford University
Stanford, California, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGAverage daily step count
Average daily step count during the intervention period measured by Fitbit 3 activity tracker
Time frame: 120 days (+/- 45 days) post-randomization
Change in 5-meter timed walk as a measure of slowness
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in exercise time as a measure of exhaustion
Exercise time on cardiopulmonary exercise testing
Time frame: 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)
Time frame: 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
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in body fat percentage
Body fat percentage is a measure of body composition
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in grip strength
Time frame: 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.
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Time frame: 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.
Time frame: 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)
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Average daily active minutes
Total average daily active minutes from Fitbit
Time frame: 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
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Average daily sedentary minutes
Average daily sedentary minutes from Fitbit
Time frame: 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
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in oxygen (O2) pulse
O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline
Time frame: 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
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in anaerobic threshold
Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline
Time frame: Baseline and 120 days (+/- 45 days) post-randomization