High Intensity Interval Training for Congenital Heart Disease
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Non-English speaking, Space limitations, Others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life. Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.
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 MedBIKE HIIT for congenital heart disease?
High-intensity interval training (HIIT) has been shown to improve aerobic fitness and cardiovascular function in patients with coronary heart disease, suggesting it could also benefit those with congenital heart disease. Additionally, home-based telemedicine exercise interventions, like MedBIKE HIIT, offer improved access and convenience, which is important for patients who live far from specialized care centers.12345
Is high-intensity interval training (HIIT) safe for people with congenital heart disease?
Research shows that high-intensity interval training (HIIT) is generally safe for people with cardiovascular conditions, including congenital heart disease. A systematic review found a low rate of major adverse events during HIIT sessions, suggesting it can be a safe exercise option when properly supervised.12678
How is MedBIKE HIIT different from other treatments for congenital heart disease?
MedBIKE HIIT is unique because it uses high-intensity interval training (short bursts of intense exercise followed by rest) combined with a video game-linked cycle ergometer, making it a fun and engaging home-based exercise option for children with congenital heart disease. This approach is novel as it incorporates telemedicine, allowing real-time monitoring and guidance, which is particularly beneficial for patients who live far from specialized care centers.124910
Eligibility Criteria
This trial is for children and teens aged 10-18 with repaired moderate-complex congenital heart disease. They must speak English, have space at home for the MedBIKE system, and not be restricted from exercising by their cardiologist. Those with severe symptoms, cognitive impairments affecting communication, or recent serious arrhythmias cannot participate.Inclusion Criteria
I am between 10 and 18 years old.
I had surgery to fix a moderate to complex heart defect.
Exclusion Criteria
My heart condition limits my physical activity.
Active medical inter-current illness limiting ability to participate
I have difficulty communicating which may affect my participation in the HIIT program.
See 11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Assessment
Participants complete baseline assessments including TACQOL and CSAPPA questionnaires, EndoPAT testing, and CPET testing
1 week
1 visit (in-person)
Treatment
Participants undergo a 12-week, home-based HIIT program using the MedBIKE, with 3 sessions per week
12 weeks
36 sessions (home-based)
Post-Intervention Assessment
Follow-up assessment including questionnaires, EndoPAT, CPET, and accelerometer wear
1-2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for sustained changes in exercise capacity and secondary outcomes at 6 and 12 months post-intervention
12 months
2 visits (in-person)
Treatment Details
Interventions
- MedBIKE HIIT (Behavioural Intervention)
Trial OverviewThe study tests a home-based high-intensity interval training (HIIT) program using a telemedicine-equipped video game-linked cycle ergometer called MedBIKE™. It aims to improve exercise capacity in youth with congenital heart disease through this novel cardiac rehabilitation approach.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MedBIKE HIITExperimental Treatment1 Intervention
MedBIKE HIIT Exercise Program
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
Loading ...
Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
Heart and Stroke Foundation of CanadaCollaborator
References
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).
High-intensity interval training versus moderate-intensity steady-state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): study protocol for a multicentre randomised controlled trial and economic evaluation. [2019]Label="INTRODUCTION">Current international guidelines for cardiac rehabilitation (CR) advocate moderate-intensity exercise training (MISS, moderate-intensity steady state). This recommendation predates significant advances in medical therapy for coronary heart disease (CHD) and may not be the most appropriate strategy for the 'modern' patient with CHD. High-intensity interval training (HIIT) appears to be a safe and effective alternative, resulting in greater improvements in peak oxygen uptake (VO2 peak). To date, HIIT trials have predominantly been proof-of-concept studies in the laboratory setting and conducted outside the UK. The purpose of this multicentre randomised controlled trial is to compare the effects of HIIT and MISS training in patients with CHD attending UK CR programmes.
FORCE Risk Stratification Tool for Pediatric Cardiac Rehabilitation and Fitness Programs. [2023]Risk stratification is required to set an exercise prescription for cardiac rehabilitation, but an optimal scheme for congenital heart disease (CHD) is unknown. We piloted a system based on hemodynamic rather than anatomic factors: function, oxygen level, rhythm, complex/coronary anatomy, and elevated load (FORCE). Feasibility, efficacy, and safety of the FORCE tool were evaluated. Patients
High-intensity interval training in patients with coronary heart disease: Prescription models and perspectives. [2022]Recently, high-intensity interval training (HIIT) has emerged as an alternative and/or complementary exercise modality to continuous aerobic exercise training (CAET) in CHD patients. However, the literature contains descriptions of many HIIT protocols with different stage durations, nature of recovery and intensities. In this review, we discuss the most recent forms of validated HIIT protocols in patients with coronary heart disease (CHD) and how to prescribe and use them during short- and long-term (phase II and III) cardiac rehabilitation programs. We also compare the superior and/or equivalent short- and long-term effects of HIIT versus CAET on aerobic fitness, cardiovascular function, and quality of life; their efficiency, safety, and tolerance; and exercise adherence. Short interval HIIT was found beneficial for CHD patients with lower aerobic fitness and would ideally be used in initiation and improvement stages. Medium and/or long interval HIIT protocols may be beneficial for CHD patients with higher aerobic fitness, and would be ideally used in the improvement and maintenance stages because of their high physiological stimulus. Finally, we propose progressive individualized models of HIIT programs (phase II to III) for patients with CHD and how to ideally use them according to the clinical status of patients and phase of the cardiac rehabilitation program.
Physical Activity Promotion in Pediatric Congenital Heart Disease: Are We Running Late? [2021]Low levels of habitual physical activity in children and adolescents with congenital heart disease (CHD) leads to various negative health outcomes, yet review of the literature indicates that many physicians, caregivers, and patients restrict physical activity owing to safety concerns. There is no evidence supporting absolute restriction of physical activity in pediatric patients with CHD; in fact, physically active lifestyles are as important for pediatric patients living with CHD as for the general population. To encourage long-term maintenance of physically active lifestyles, physical activity counselling and exercise prescription should be started early in childhood and be a core component of every patient encounter. Physical activity counselling should include clear messaging from physicians about recommended physical activities-not just restrictions-and a personalised written exercise prescription for the patient and family. Regular follow-up is essential to ensure adherence to recommendations, monitor patient responses to the increased physical activity level, and long-term surveillance. This review discusses the importance of a physically active lifestyle in children and adolescents with and without surgically repaired CHD and hypertrophic cardiomyopathy, excluding those with electrical abnormalities and channelopathies. It outlines gaps in knowledge regarding best practices for physical activity promotion in these patient populations, and provides recommendations on how to include physical activity promotion and exercise prescription in clinical practice based on existing literature. An important role for clinicians is identified, because the type of messaging they provide regarding physical activity will have a major impact on patients' and families' decisions to adopt an active lifestyle.
Exercise and training in adults with congenital heart disease. [2007]Patients with congenital heart disease run the risk of overweight and low physical activity. Lifestyle measures are as important in these patients as in the general population. Exercise testing is an effective tool to identify patients in whom exercise may induce arrhythmias or hemodynamic instability but more often to reveal the safety of exercise, which is the conclusion in the majority of these patients. Systematic training programs have only been introduced to small groups of patients with congenital heart disease, and there are only few data on the effects obtained. The studies concluded that the exercise training programs used were safe.
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.
High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]Background Cardiac rehabilitation ( CR ) for patients with cardiovascular disease has traditionally involved low- to moderate-intensity continuous aerobic exercise training ( MICT ). There is growing and robust evidence that high-intensity interval training ( HIIT ) shows similar or greater efficacy compared with MICT across a range of cardiovascular and metabolic measures, in both healthy populations and populations with a chronic illness. However, there is understandable concern about the safety aspects of applying HIIT in CR settings. This systematic review analyzed safety data drawn from recent proof-of-concept studies of HIIT during CR among patients with cardiovascular disease. Methods and Results We included trials comparing HIIT with either MICT or usual care in patients with coronary artery disease or heart failure participating in tertiary care services, such as phase 2 (outpatient) CR . Adverse events occurring during or up to 4 hours after an exercise training session were collated. There were 23 studies included, which analyzed 1117 participants ( HIIT =547; MICT =570). One major cardiovascular adverse event occurred in relation to an HIIT session, equating to 1 major cardiovascular event per 17 083 training sessions (11 333 training hours). One minor cardiovascular adverse events and 3 noncardiovascular adverse events (primarily musculoskeletal complaints) were also reported for HIIT . Two noncardiovascular events were reported in relation to MICT . Conclusions HIIT has shown a relatively low rate of major adverse cardiovascular events for patients with coronary artery disease or heart failure when applied within CR settings.
Effects of Sports, Exercise Training, and Physical Activity in Children with Congenital Heart Disease-A Review of the Published Evidence. [2023]Children and adolescents with congenital heart disease (CHD) should be encouraged to adopt a physically active lifestyle, ideally by participating in sports activities at school and sports clubs. Children with complex CHD or other risk factors (for example, pacemakers, cardioverter-defibrillators, channelopathies) may, however, need specific individualized training programs. This review article summarizes the current knowledge regarding the clinical effects of sports and exercise training on CHD and its pathophysiologic mechanisms. An evidence-based approach based on a literature search, using PubMed, Medline, CINHAL, Embase, and the Cochrane Library was conducted, last completed on 30 December 2021. In studies with 3256 CHD patients in total, including 10 randomized controlled trials, 14 prospective interventional trials, 9 observational trials, and 2 surveys, exercise training has been shown to improve exercise capacity and physical activity, motoric skills, muscular function, and quality of life. Sports and exercise training appears to be effective and safe in CHD patients. Despite being cost-efficient, training programs are currently scarcely reimbursed; therefore, support from healthcare institutions, commissioners of healthcare, and research-funding institutions is desirable. There is a strong need to establish specialized rehabilitation programs for complex CHD patients to enhance these patients' access to this treatment intervention. Further studies may be desirable to confirm these data to investigate the impact on risk profiles and to identify the most advantageous training methodology and underlying pathophysiological mechanisms.
Effects of 12-Week Home-based Resistance Training on Peripheral Muscle Oxygenation in Children With Congenital Heart Disease: A CHAMPS Study. [2023]Label="Background" NlmCategory="UNASSIGNED">A hallmark feature of children with congenital heart disease (CHD) is exercise intolerance. Whether a home-based resistance training intervention improves muscle oxygenation (as measured by tissue oxygenation index, TOI) and exercise tolerance (V˙O2 reserve) during aerobic exercise in children with CHD compared with healthy children is unknown.