High Intensity Interval Training in Pediatric Heart Transplant Recipients: Evaluating a Novel Telemedicine Video Game-Linked Exercise Platform (MedBIKE™)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric heart transplant recipients.
研究概览
简要总结
Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant. With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This includes strategies aimed at optimizing cardiorespiratory fitness and physical activity levels.
Pediatric and adult HTRs have reduced exercise capacity compared with the general population. Previous groups have shown gradual improvements in heart rate response to exercise and exercise capacity in pediatric HTRs. However, after an initial improvement, exercise capacity appears to plateau, or even decline in pediatric HTRs, and remains sub-optimal compared with the general population.
Most exercise interventions in HTRs to date have focused on moderate-intensity continuous exercise (MICE), with some resistance components incorporated. More recently, high-intensity interval training (HIIT), consisting of short, intense bursts of exercise with rest periods, has been explored in the adult HTR population, with findings to date suggesting that it may yield greater improvements in cardiorespiratory fitness compared with MICE. Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are linked with improved long-term post-transplant outcomes and well-being. Unfortunately, trials of exercise interventions in pediatric HTRs remain lacking. This study team is proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enable video game linked customizable cycle ergometer (MedBIKE™).
详细描述
Purpose: To determine the feasibility of MedBIKE™ in a 12-week home-based high intensity interval training program in pediatric heart transplant recipients (HTRs).
Hypothesis: The MedBIKE™ intervention will be feasible, with adequate enrolment of eligible participants (>60%), high session compliance (>80%), and low-drop out rate (~10%), with no adverse events directly related to the intervention. The investigators further hypothesize that the MedBIKE™ HIIT intervention will result in immediate and sustained improvements in exercise capacity, physical activity, self-efficacy towards physical activity, and HRQoL.
Justification: Clinical trials of exercise interventions in pediatric HTRs remains significantly lacking. This lack of literature to date has been identified as a significant knowledge gap in the Canadian Society of Transplantation/CAN-RESTORE recent joint statement. While the findings to date indicate that exercise interventions in pediatric HTRs may show improvements in exercise capacity, numerous knowledge gaps remain. For example, despite promising findings in adult HTRs, HIIT has not yet been studied in pediatric HTRs. Moreover, the effect of exercise interventions on physical activity, HRQoL, and self-efficacy towards physical activity have not been well studied. It is important to evaluate whether a supervised exercise intervention at near-maximal intensity can promote improvements in physical activity self-efficacy that may in turn yield sustained improvements in physical activity. One of the limiting factors for regular participation in post-transplant exercise programs is the necessary time commitment that is intensified in a program with demographics such as ours in Western Canada with many post-transplant children living far from the transplant center and with limited access to exercise facilities. A supervised home-based training program could optimize the time-efficiency and accommodate the patient's routine schedules. Thus, the investigators are proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enabled video game-linked customizable cycle ergometer (MedBIKE™).
Objectives: (Primary) Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric HTRs. (Secondary) Evaluate the impact of the MedBIKE™ HIIT intervention on 1) exercise capacity; 2) physical activity; 3) self-efficacy towards physical activity; 4) HRQoL and 5) sustained changes in all secondary outcomes at 6- and 12-months post-intervention.
Research Method: Single-center, randomized crossover feasibility trial with a multi-method approach. Potential participants and families will be approached first by a clinical team member. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric heart transplant recipients, at least 6-months post heart transplantation
- •Aged 10-18 years
排除标准
- •Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- •Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)
- •History of multiorgan transplant
- •Adult unavailable to supervise the home-based exercise sessions
- •Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment
- •Previous involvement in a cardiac rehabilitation or exercise intervention program
- •Primary cardiologist has exercise restricted the participant or counsels against participation
- •Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope
- •Resting arterial saturation <85% or oxygen requirements
- •Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- •History of chest pain on exertion
- •Unrepaired/unpalliated CHD
- •Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse))
- •New York Heart Association class II or worse symptoms
- •Active medical inter-current illness limiting ability to participate
- •Cognitive impairment limiting the communication needed for the HIIT program
- •Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
研究组 & 干预措施
MedBIKE HIIT
Participants will complete the baseline assessments and begin the MedBIKE HIIT Exercise Program intervention within 2-weeks. After the completion of the 12-week program, participants will return for follow-up assessments which will be repeated at 6- and 12-months post intervention.
干预措施: MedBIKE HIIT (Device)
Standard of Care
Participants will complete the baseline assessments and continue with standard of care (no intervention) for 12-weeks then return for a repeat assessment. Participants will then crossover into the MedBIKE HIIT Exercise Program intervention group for 12-weeks. A post-intervention assessment will be completed and follow-up assessments at 6- and 12-months post intervention.
结局指标
主要结局
Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric heart transplant recipients.
时间窗: 12 weeks
Pediatric heart transplant participants will be provided with a MedBIKE™ system to complete a video game linked 12-week high intensity interval training program equipped with telemedicine capabilities. Feasibility will be defined as adequate recruitment of eligible participants (greater than 60 percent), high session compliance (greater than 80 percent), low drop-out rate (less than 10 percent) and safety in terms of no severe adverse events related to the intervention.
次要结局
- Changes in cardiac specific health-related quality of life will be measured using the PedsQL Cardiac Module questionnaire.(13 months)
- Exercise capacity through the change in VO2peak (mL/kg/min) measured using CPET testing.(13 months)
- Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.(13 months)
- Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention(13 months)