NCT05619211已完成1 期
Improving Cardiorespiratory Fitness and Cardiometabolic Health Among Children With Physical Disabilities Through Movement-to-Music Telehealth With Arm-based Sprint-Intensity Interval Training
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes in pVO2
研究概览
简要总结
This study is investigating the potential effects of a high-intensity home-exercise program among children with cerebral palsy. The program includes rhythmic movements to music that are adapted for wheelchair uses and age-appropriate themes. This project has the potential to address a large knowledge gap in the extant literature, because there are no widely accessible, evidence-based, enjoyable, and age-appropriate modalities for improving cardiovascular fitness or cardiometabolic health among children with disabilities who have mobility disabilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •We are recruiting 50 parent-child dyads. Childs are the participant undergoing the exercise intervention. Parents are required to support the safety and schedule of the child participant. Parents are considered participants due to their responsibilities.
- •Inclusion Criteria:
- •have a medical diagnosis of cerebral palsy, as determined by ICD-10 codes
- •aged 6-17 years old
- •a Gross Motor Function Classification System Level I-IV (as determined via participant screening, explained in the protocol section below)
- •medical clearance to participate in high-intensity exercise from a physician (using the attached medical screening form and explained in the intervention safety, monitoring, and response plan)
- •access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
- •a caregiver who will support and monitor the participant's safety during the intervention and manage the child's exercise schedule.
排除标准
- •physically active (defined as >150 minutes per week of self-reported moderate-to-vigorous intensity exercise in a typical week)
- •cannot use their arms for exercise
- •a Gross Motor Function Classification Level of V
- •complete blindness or deafness;
- •Any past history of a contraindication to exercise testing according to American College of Sports Medicine (ACSM) guidelines (Liguori and American College of Sports Medicine, 2020): significant change in the resting electrocardiogram suggesting significant ischemia, myocardial infarction, or other cardiac event, unstable angina, uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, pulmonary embolus or pulmonary infarction, myocarditis or pericarditis, aneurysm.
- •pregnant (due to radiation from a Dual Energy X-ray Absorptiometry [DEXA] scan)
- •has not been seen by a physician within the last year
- •uses a g-tube
- •Eligible caregivers will include parents or legal guardians of the child, who can commit sufficient time to support the child in their roles for the study and communicate in English. Caregivers who have complete blindness or deafness will be excluded from participation.
结局指标
主要结局
Changes in pVO2
时间窗: Week 0, Week 13
peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer
次要结局
- changes in Hemoglobin A1C(Week 0, Week 13)
- changes in fasting high-density lipoprotein(Week 0, Week 13)
- changes in fasting low-density lipoprotein(Week 0, Week 13)
- Changes in systolic blood pressure(Week 0, Week 13)
- changes in total body fat(Week 0, Week 13)
- changes in fat tissue percentage(Week 0, Week 13)
- changes in fasting insulin(Week 0, Week 13)
- changes in fasting triglycerides(Week 0, Week 13)
- Changes in diastolic blood pressure(Week 0, Week 13)
- change in body weight(Week 0, Week 13)
- changes in total lean mass(Week 0, Week 13)
- changes in C-reactive protein(Week 0, Week 13)
- changes in lean tissue percentage(Week 0, Week 13)
研究者
Byron Lai
Assistant Professor
University of Alabama at Birmingham
研究点 (2)
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