Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04575883
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2020-08-28
Brief Title:
HIIT in Youth With Congenital Heart Disease MedBIKE
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
High Intensity Interval Training in Youth With Congenital Heart Disease A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Purpose This project is a prospective clinical trial of a home-based high intensity interval training HIIT exercise program using a novel telemedicine-enabled and video game-linked customizable cycle ergometer MedBIKE in the pediatric congenital heart disease CHD population
Hypothesis The home-based the MedBIKE HIIT program will significantly improve exercise capacity The MedBIKE intervention will significantly improve time spent in MVPA and reduce sedentary time improve HRQoL and self-efficacy towards PA and improve endothelial function Moreover the investigators hypothesize that the improvements in exercise capacity along with the improvements in the secondary outcomes will remain significantly improved up to one-year post- MedBIKE intervention when compared to pre-intervention values
Justification Exercise intervention studies in the pediatric CHD population have been limited by small sample sizes and there is limited data pertaining to the sustained effects of exercise interventions on exercise capacity physical activity endothelial function and quality of life This study using standardized and largely operator-independent measure will be one of the largest exercise intervention clinical trials in the pediatric CHD population
Primary Objective Evaluate the impact of an eight-week home-based HIIT MedBIKE program on exercise capacity in youth with repaired moderate-complex CHD
Secondary Objectives Evaluate the impact of the MedBIKE intervention on 1 PA 2 HRQoL and self-efficacy towards PA 3 endothelial function and 4 sustained changes in the primary and secondary outcomes
Research Method This will be a single-center prospective clinical trial Potential participants and families will be approached first by a clinical team member In addition flyers with key study information will be placed in waiting rooms of the pediatric cardiology clinics Participants and parents expressing interest will meet with a research coordinator who along with one of the investigators and the clinical team will screen for eligibility Written consent and assent if applicable will be obtained from participants who are deemed eligible
Following recruitment participants will be administered the TACQOL and CSAPPA questionnaires and an accelerometer to be worn for 7-days after which participants will arrive for the baseline assessment As participants must be NPO for EndoPAT testing they will have a small meal following EndoPAT testing and at least two hours prior to CPET testing A MedBIKE will be installed in the participants home within 2-weeks of the baseline CPET at which time an orientation session will occur to review the manual safety procedures and the telemedicine component Participation will consist of a 12-week 3-times per week 36 sessions in total HIIT program All sessions will be supervised by an exercise physiologist Protocol completion will be considered a minimum of 27 of the 36 sessions 75 Following the completion of the intervention the MedBIKE will be removed by the participants home and returned to the Stollery Childrens Hospital
A follow-up assessment identical to that of the baseline questionnaires EndoPAT CPET interviews and a 7-day week wear of an accelerometer will occur 3-14 days post-intervention These assessments will be repeated at 6- and 12-months post-intervention
Hypothesis The home-based the MedBIKE HIIT program will significantly improve exercise capacity The MedBIKE intervention will significantly improve time spent in MVPA and reduce sedentary time improve HRQoL and self-efficacy towards PA and improve endothelial function Moreover the investigators hypothesize that the improvements in exercise capacity along with the improvements in the secondary outcomes will remain significantly improved up to one-year post- MedBIKE intervention when compared to pre-intervention values
Justification Exercise intervention studies in the pediatric CHD population have been limited by small sample sizes and there is limited data pertaining to the sustained effects of exercise interventions on exercise capacity physical activity endothelial function and quality of life This study using standardized and largely operator-independent measure will be one of the largest exercise intervention clinical trials in the pediatric CHD population
Primary Objective Evaluate the impact of an eight-week home-based HIIT MedBIKE program on exercise capacity in youth with repaired moderate-complex CHD
Secondary Objectives Evaluate the impact of the MedBIKE intervention on 1 PA 2 HRQoL and self-efficacy towards PA 3 endothelial function and 4 sustained changes in the primary and secondary outcomes
Research Method This will be a single-center prospective clinical trial Potential participants and families will be approached first by a clinical team member In addition flyers with key study information will be placed in waiting rooms of the pediatric cardiology clinics Participants and parents expressing interest will meet with a research coordinator who along with one of the investigators and the clinical team will screen for eligibility Written consent and assent if applicable will be obtained from participants who are deemed eligible
Following recruitment participants will be administered the TACQOL and CSAPPA questionnaires and an accelerometer to be worn for 7-days after which participants will arrive for the baseline assessment As participants must be NPO for EndoPAT testing they will have a small meal following EndoPAT testing and at least two hours prior to CPET testing A MedBIKE will be installed in the participants home within 2-weeks of the baseline CPET at which time an orientation session will occur to review the manual safety procedures and the telemedicine component Participation will consist of a 12-week 3-times per week 36 sessions in total HIIT program All sessions will be supervised by an exercise physiologist Protocol completion will be considered a minimum of 27 of the 36 sessions 75 Following the completion of the intervention the MedBIKE will be removed by the participants home and returned to the Stollery Childrens Hospital
A follow-up assessment identical to that of the baseline questionnaires EndoPAT CPET interviews and a 7-day week wear of an accelerometer will occur 3-14 days post-intervention These assessments will be repeated at 6- and 12-months post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None