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This study is a single center randomized controlled trial evaluating the effect of an exercise training intervention (interval training or moderate continuous training) compared to usual care (no training) on exercise capacity in patients with congenital heart disease (CHD).
Our primary aim is to determine the impact of interval training (IT) compared to moderate continuous exercise training (MCT) versus controls (no exercise) on exercise capacity as measured by peak VO2. Secondary aims are to: 1) assess the safety of exercise training in CHD, 2) evaluate the effect of exercise training on cardiac structure and function and 3) assess the effects of exercise training on quality of life and long-term physical activity.
Adults with congenital heart disease (ACHD) have reduced exercise capacity which is an independent predictor of adverse outcome including hospitalization and mortality in this patient population. When aerobic exercise capacity is measured by cardiopulmonary exercise testing (CPET), peak oxygen consumption (peak VO2) averages 22ml/kg/min in ACHD, less than half of age matched controls, and similar to patients with heart failure. Factors contributing to low exercise capacity include central factors related to abnormal cardiac anatomy, ventricular systolic and diastolic dysfunction, valvular abnormalities, pulmonary hypertension, chronotropic incompetence and impaired pulmonary function as well as peripheral factors such as skeletal muscle conditioning. Clinicians may further contribute to reluctance around exercise by failing to encourage physical activity or giving inappropriate exercise restrictions to ACHD.
The aim of our study was to explore the efficacy of HIIT compared to MCT on aerobic exercise capacity as measured by peak VO2 in ACHD patients. Secondary aims were to determine the effect of exercise on various physiologic variables, to assess the safety of HIIT in ACHD, to evaluate the effect of exercise training on cardiac structure and function as assessed by cardiac MRI and to measure the impact of exercise training on quality of life (QoL).
This was a single center randomized controlled trial designed in accordance with CONSORT guidelines. Participants were randomized with a 1:1:1 ratio into three groups: HIIT, MCT or control group. Randomization occurred by clusters defined by week of attendance in the clinic. Permuted blocks of 3, 6, and 9 were used to ensure a similar number of weeks randomized to the three groups, with randomization sequence generated by one author (AM). Participants were enrolled by a study coordinator who assigned participants to one of the three groups. Participants underwent testing at baseline and after 12 weeks of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIIT | Experimental | High intensity interval training: 3 session per week of long-interval protocol involving 5 minutes of warmup, 5 intervals of 4 minutes of internse aerobic activity with 4 periods of 3 minutes of low to moderate intensity activity and a 5 minute cool down period. |
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| MCT | Experimental | Moderate continuous training: 3 sessions per week involving a 5 minut warmup, 40 minutes of aerobic activity and 5 minutes of cool down. |
|
| Control | No Intervention | Control group participants will continue their usual level of physical activity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Participants will take part in 3 exercise sessions per week of either HIIT or MCT training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in peak VO2 from baseline to 12 weeks post enrollment | Participants will complete a cardiopulmonary exercise test at baseline and after 12 weeks to determine peak VO2 values. | From enrollment to the end of the 12 week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of adverse events | High intensity exercise has the potential to transiently increase the risk of arrhythmias and myocardial infarction in susceptible persons. Participants will be monitored throughout exercise for any adverse events defined as cardiac arrest, myocardial infarction, sustained ventricular or suprraventricular arrhythmias or heart failure. | Participants will be monitored throughout the exercise training and one hour afterward. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jim Pattison Center for Cardiac Rehabilitation | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10814630 | Background | Swan L, Hillis WS. Exercise prescription in adults with congenital heart disease: a long way to go. Heart. 2000 Jun;83(6):685-7. doi: 10.1136/heart.83.6.685. | |
| 24204010 | Background | Budts W, Borjesson M, Chessa M, van Buuren F, Trigo Trindade P, Corrado D, Heidbuchel H, Webb G, Holm J, Papadakis M. Physical activity in adolescents and adults with congenital heart defects: individualized exercise prescription. Eur Heart J. 2013 Dec;34(47):3669-74. doi: 10.1093/eurheartj/eht433. Epub 2013 Nov 7. No abstract available. |
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Individual participant data will not be shared. Data will be analyzed and presented per treatment group.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2019 | Apr 14, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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This study is a 3-arm single center randomized controlled trial. Participants will be randomized to HIIT, MCT or control group
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| Cardiac adaptation | Cardiac MRI will be used to assess right ventricular volumes and ejection fraction. Pulmonary regurgitation fraction, left ventricular volumes and ejection fraction will also be assess. | Cardiac MRI's will be performed at baseline with follow-up scans at 4 weeks of starting and at completion of the 12 week intervention. |
| The effect of exercise training on quality of life. | Participants will complete a quality of life questionnaire, satisfaction with life scale and New York Heart Association (NYHA) Functional Classification. | Participants will complete questionnaires during study visits or be sent a link by email to complete the questionnaires on-line at baseline, 3 months (after exercise training intervention) and 6 months after randomization. |
| Impact of exercise program on physical activity levels. | Participants will wear SenseWear arm bands (accelerometers) to describe baseline physical activity levels and to assess long-term changes in physical activity 6 months after randomization. Data will be acquired for 4 days at each time-point and change from baseline compared between exercise training groups and usual care. | Participants will wear the accelerometers at baseline and 6 months after randomization to collect data for 4 days. |
| 21641052 | Background | Holloway TM, Chesssex C, Grace SL, Oechslin E, Spriet LL, Kovacs AH. A call for adult congenital heart disease patient participation in cardiac rehabilitation. Int J Cardiol. 2011 Aug 4;150(3):345-6. doi: 10.1016/j.ijcard.2011.05.031. Epub 2011 Jun 8. No abstract available. |
| 16061735 | Background | Diller GP, Dimopoulos K, Okonko D, Li W, Babu-Narayan SV, Broberg CS, Johansson B, Bouzas B, Mullen MJ, Poole-Wilson PA, Francis DP, Gatzoulis MA. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005 Aug 9;112(6):828-35. doi: 10.1161/CIRCULATIONAHA.104.529800. Epub 2005 Aug 1. |
| 17210844 | Background | Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8. |
| 42362048 | Derived | Mao RT, Willner JP, Pylypchuk S, Mathew A, Windram J, Mackie AS, Haennel R, Vonder Muhll IF. High Intensity Interval Training Versus Moderate Continuous Training in Adults with Congenital Heart Disease: A Randomized Controlled Trial. Can J Cardiol. 2026 Jun 26:S0828-282X(26)00642-2. doi: 10.1016/j.cjca.2026.06.020. Online ahead of print. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |