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There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.
Exercise cardiac MRI's are the non-invasive gold standard for assessing biventricular function during exercise. While exercise MRI has not been previously studied in pediatric HTRs, it has been effectively utilized in children with single ventricle congenital heart disease. The purpose of this study is to fully understand the cardiac adaptations induced by exercise training.
Primary objective: Evaluate the association between exercise MRI cardiac and skeletal muscle measures and cardiorespiratory fitness in pediatric acquired (HTRx) and CHD participants.
Hypothesis: Cardiac adaptations to exercise and skeletal muscle functioning will be positively associated with measured CRF in CHD patients and those post-transplant.
Secondary objective: Evaluate changes in exercise MRI measures of cardiac and skeletal muscle function following a 12-week high-intensity interval training (HIIT) exercise protocol in children with acquired and congenital heart disease.
Hypothesis: a 12-week HIIT intervention will result in improvements in cardiac and skeletal muscle responses to exercise.
This will be a single-center, prospective observational study.
Participants will include 10-18 year old pediatric heart transplant recipients (HTR) and congenital heart disease (CHD) patients followed at the Stollery Children's Hospital.
Participants will undergo cardiopulmonary exercise testing (CPET) using a cycle ergometer and standardized protocols. On a separate day (within 2 weeks of the testing), participants will return and undergo a standard cardiac MRI to assess resting ventricular structure and function. They will then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer.
Participants and their parent will also be asked to complete questionnaires to determine their feelings towards exercise and physical activity.
As this will be a single-center study. The analysis will be largely exploratory and the sample size will be determined based on the available patient population. Based on a review of potentially eligible participants at our center, the investigators anticipate recruiting 10 participants post-HTR and 10 CHD participants to evaluate the primary objective. As the secondary objective (changes in cardiac and skeletal muscle MRI measures) requires repeated assessments and involvement in the MedBIKEâ„¢ HIIT trial, recruitment to address this objective may be lessened; the investigators thus anticipate recruiting ~6 participants post-transplant and 6 participants with CHD. The statistical analysis will be carried out in collaboration with the Women and Children's Health Research Institute (WCHRI) biostatistics team (accounted for in budget). Differences in MRI and CPET measures among participants, and changes in the measures (Objective 2) will be evaluated by independent t-tests or Mann-Whitney tests for continuous variables and chi-square or Fisher's exact tests for categorical variables. Pearson correlations will be used to evaluate associations between VO2peak (and other CPET measures of CRF) and measures of cardiac function and output and peripheral muscle oxygen extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Congenital heart disease | Participants aged 10-18 years who have congenital heart disease. |
| |
| Heart transplant recipient | Participants aged 10-18 years who have recieved a heart transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise cardiac MRI Assessment | Diagnostic Test | Participants will undergo a standard cardiac MRI to assess resting ventricular structure and function then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI assessment of cardiac structure at rest | Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular structure. | Baseline |
| MRI assessment of cardiac function at rest | Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular function. | Baseline |
| Maximal exercise MRI assessment of cardiac structure | Participants will undergo an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer (Cardio Step Module, Ergospect) to assess cardiac output. | Baseline |
| Cardioplumonary Exercise Test | Participants will undergo a cardiopulmonary exercise test using a cycle ergometer to assess VO2peak. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in this study will be 10-18 year olds, with acquired or congenital heart disease, that are followed by the Stollery Children's Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rae Foshaug | Contact | 780-407-7499 | rae.foshaug@albertahealthservices.ca | |
| Michael Khoury, MD | Contact | 780-492-0103 | khoury1@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Khoury, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32716280 | Background | Khoury M, Phillips DB, Wood PW, Mott WR, Stickland MK, Boulanger P, Rempel GR, Conway J, Mackie AS, Khoo NS. Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme. Cardiol Young. 2020 Oct;30(10):1409-1416. doi: 10.1017/S1047951120002097. Epub 2020 Jul 27. | |
| 37657493 |
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Individual participant data will not be shared with other researchers. All data will be de-identified prior to analysis and published.
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Cardiopulmonary Exercise Test | Diagnostic Test | Cardiopulmonary exercise testing will be performed using a cycle ergometer. Consistent with standard guidelines, workload will progressively increase (10W ramp protocol) such that peak oxygen consumption (VO2peak) is achieved within 8-12 minutes. VO2peak, VO2 at anaerobic threshold, peak power output (PPO), ventilation/carbon dioxide production (VE/VCO2) slope, peak heart rate (HR), and HR recovery at 1- and 3-minutes will be recorded. VO2peak will be converted to age-, weight, and sex-specific norms and a %predicted value. |
|
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| Spence C, Khoo N, Mackie A, Conway J, Rowland S, Foshaug R, Boulanger P, Spence JC, Stickland MK, Khoury M. Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Can J Cardiol. 2023 Nov;39(11S):S346-S358. doi: 10.1016/j.cjca.2023.08.015. Epub 2023 Aug 30. |
| 37969861 | Background | Spence CM, Foshaug R, Rowland S, Krysler A, Conway J, Urschel S, West L, Stickland M, Boulanger P, Spence JC, Khoury M. Evaluating a Telemedicine Video Game-Linked High-Intensity Interval Training Exercise Programme in Paediatric Heart Transplant Recipients. CJC Pediatr Congenit Heart Dis. 2023 Apr 11;2(4):198-205. doi: 10.1016/j.cjcpc.2023.04.001. eCollection 2023 Aug. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |