Lifestyle Program for Congenital Heart Disease
(CHD-PALS V2 Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jamie Jackson
Disqualifiers: Genetic syndromes, Cognitive impairments, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Congenital Heart Disease Physical Activity Lifestyle Intervention?
Research shows that physical activity is linked to better exercise capacity and quality of life in adults with congenital heart disease. Regular physical activity can improve aerobic fitness and may reduce health issues over time.
12345Is the Lifestyle Program for Congenital Heart Disease safe for humans?
Research shows that home-based, self-selected exercise training is safe for adults with congenital heart disease, suggesting that similar lifestyle programs are generally safe for humans.
34567How is the CHD-PAL treatment different from other treatments for congenital heart disease?
The CHD-PAL treatment is unique because it focuses on a lifestyle intervention that encourages physical activity specifically tailored for individuals with congenital heart disease, rather than relying on medication or surgery. This approach aims to improve exercise capacity and overall health through a structured physical activity program, potentially using telemedicine to enhance accessibility and convenience.
568910Eligibility Criteria
This trial is for young people aged 15-25 with moderate to complex congenital heart disease, who are patients at Nationwide Children's Hospital or Ohio State University. They must be able to speak and read English well, not have had recent major heart surgery, and can't already be very physically active or in another exercise program.Inclusion Criteria
Currently seeing a heart doctor at Nationwide Children's Hospital or Ohio State University.
I have been diagnosed with a moderate or complex heart defect.
I am between 15 and 25 years old.
Exclusion Criteria
Your heart doctor says you can't do at least moderate physical activity.
You have been in a regular exercise program in the last 6 months.
I have not had open-heart surgery or valve replacement in the last 3 months.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a 20-week videoconferencing-administered intervention including 9 sessions to increase physical activity and healthy living
20 weeks
9 virtual sessions
Interim Follow-up
Participants' physical activity and TPB mechanisms are assessed 20 weeks post-intervention
20 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
40 weeks
Participant Groups
The study tests a lifestyle program that includes education on healthy living, monitoring physical activity levels, personalized exercise plans, and interventions based on the Theory of Planned Behavior to improve cardiovascular health in adolescents and young adults with congenital heart disease.
2Treatment groups
Experimental Treatment
Active Control
Group I: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) InterventionExperimental Treatment4 Interventions
In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.
Group II: Living Well with Congenital Heart Disease (LIV-CHD) InterventionActive Control3 Interventions
In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nationwide Children's HospitalColumbus, OH
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Who Is Running the Clinical Trial?
Jamie JacksonLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Physical activity in adults with congenital heart disease and associations with functional outcomes. [2022]Improved survival has yielded to growing importance of functional outcome measures in patients with congenital heart disease (CHD). This study applied the International Physical Activity Questionnaire (IPAQ) to assess self-reported physical activity (PA) in patients with CHD and their association with exercise capacity and health-related quality of life (HrQoL).
Physical activity is associated with improved aerobic exercise capacity over time in adults with congenital heart disease. [2021]Impaired exercise capacity is common in adults with congenital heart disease (ACHD). This impairment is progressive and is associated with increased morbidity and mortality. We studied the influence of the frequency of at least moderately strenuous physical activity (PhysAct) on changes in exercise capacity of ACHD patients over time.
Patient reported outcomes are associated with physical activity level in adults with congenital heart disease. [2022]In general, adults with congenital heart disease (CHD) have impaired exercise capacity, and approximately 50% do not reach current recommendations on physical activity. Herein we analysed factors associated with physical activity level (PAL) in adults with CHD by using patient-reported outcomes (PRO).
Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial. [2017]Intensive exercise may be an important part of rehabilitation in patients with congenital heart disease (CHD). However, performing regular physical exercise is challenging for many adolescent patients. Consequently, effective exercise encouragements may be needed. Little is known on the effect of e-Health encouragements on physical fitness, physical activity, and health-related quality of life in adolescents. This trial is a nationwide interactive e-Health rehabilitation study lasting 1 year, centered on interactive use of mobile phone and Internet technology. We hypothesize that e-Health encouragements and interactive monitoring of intensive exercise for 1 year can improve physical fitness, physical activity, and health-related quality of life. Two hundred sixteen adolescents (age, 13-16 years) with surgically corrected complex CHD but without significant hemodynamic residual defects and no restrictions to participate in physical activity are in the process of being enrolled by invitation after informed consent. Physical fitness is measured as the maximal oxygen uptake (Vo(2)) at baseline and after 12 months by an assessor blinded to the randomization group. After baseline testing, the patients are 1:1 randomized to an intervention group or a control group. Individually fully automated tailored e-Health encouragements--SMS, Internet, and mobile applications--aimed at increasing physical activity are delivered to the participants in the intervention group once a week. The Bandura's Social Cognitive Theory inspires the behavioral theoretical background. The e-Health intervention and the Godfrey cycle ergometer protocol have been feasibility tested and seem applicable to adolescents with CHD. The trial is expected to contribute with new knowledge regarding how physical activity in adolescents with CHD can be increased and, possibly, comorbidity be reduced.
Adults with congenital heart disease overestimate their physical activity level. [2022]Physical activity reduces the risk of acquired cardiovascular disease, which is of great importance in patients with congenital heart disease (CHD). There are diverging data whether physical activity level (PAL) differs between patients with CHD and controls. Furthermore, it is unknown if PAL can be reliably assessed in patients with CHD using self-reported instruments.
Safety and effectiveness of home-based, self-selected exercise training in symptomatic adults with congenital heart disease: A prospective, randomised, controlled trial. [2019]The purpose of this prospective randomised controlled trial was to assess whether home-based, self-selected exercise training is safe, results in high compliance and improves exercise capacity in symptomatic adults with congenital heart disease (CHD).
Exercise capacity, physical activity, and health-related quality of life in adults with CHD. [2021]The aim of this study was to assess exercise capacity, physical activity, and health-related quality of life within a broad and unselected group of adults with CHD.
Enablers and barriers for being physically active: experiences from adults with congenital heart disease. [2021]In general, adults with congenital heart disease have reduced exercise capacity and many do not reach the recommended level of physical activity. A physically active lifestyle is essential to maintain health and to counteract acquired cardiovascular disease, therefore enablers and barriers for being physically active are important to identify.
Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. [2023]Youth with congenital heart disease (CHD) have reduced exercise capacity via various physical and psychosocial mechanisms. In addition to limited physiologic exercise capacity, these patients experience lower levels of physical activity, physical activity self-efficacy, health-related quality of life, and endothelial function. The study of exercise interventions and cardiac rehabilitation programs in pediatric CHD populations remains limited, particularly home-based interventions that incorporate real-time physiologic monitoring. Home-based interventions provide improved access and convenience to patients. This is principally important for patients from geographically disperse regions who receive their care at centralized subspecialty centres, as is the case for Canadian pediatric cardiac care. These programs, however, have traditionally not permitted the supervision of safety, technique, and adherence that are afforded by hospital/facility-based programs. As such, telemedicine is an important evolving area that combines the benefits of traditional home and facility-based cardiac rehabilitation. An additional key area lacking study surrounds the types of exercise interventions in youth with CHD. To date, interventions have often centred around moderate-intensity continuous exercise. High-intensity interval training might offer superior cardiorespiratory advantages but remains understudied in the CHD population. In this review, we highlight the existing evidence basis for exercise interventions in youth with CHD, explore the promise of incorporating telemedicine home-based solutions, and highlight key knowledge gaps. To address identified knowledge gaps, we are undertaking a 12-week randomized crossover trial of a home-based telemedicine high-intensity interval training intervention in youth with repaired moderate-severe CHD using a video game-linked cycle ergometer (known as the MedBIKE; https://spaces.facsci.ualberta.ca/ahci/projects/medical-projects/remote-rehab-bike-projects).
Risks and Benefits of Exercise Training in Adults With Congenital Heart Disease. [2022]Exercise capacity in adults with various forms of congenital heart disease is substantially lower than that of the general population. Although the underlying congenital heart defect, and its sequelae, certainly contribute to observed exercise limitations, there is evidence suggesting that deconditioning and a sedentary lifestyle are important implicated factors. The prevalence of acquired cardiovascular comorbidities is on the increase in the aging population with congenital heart disease, such that obesity and a sedentary lifestyle confer increased risk. Health fears and misconceptions are common barriers to regular physical activity in adults with congenital heart disease, despite evidence linking lower functional capacity to poor outcomes, and data supporting the safety and efficacy of exercise in bestowing numerous physical and psychosocial rewards. With few exceptions, adults with congenital heart disease should be counselled to exercise regularly. In this contemporary review, we provide a practical approach to assessing adults with congenital heart disease before exercise training. We examine available evidence supporting the safety and benefits of exercise training. Risks associated with exercise training in adults with congenital heart disease are discussed, particularly with regard to sudden cardiac death. Finally, recommendations for exercise training are provided, with consideration for the type of congenital heart disease, the nature (ie, static vs dynamic) and intensity (ie, low, medium, high) of the physical activity, and associated factors such as systemic ventricular dysfunction and residual defects. Further research is required to determine optimal exercise regimens and to identify effective strategies to implement exercise training as a key determinant of healthy living.