Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With a High Protein Diet in Children With Obesity Following COVID-19 Infection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
The coronavirus disease (COVID-19), is a communicable pandemic disease as stated by the world health organization (WHO), which has been affecting the world since December 2019. COVID-19 infected children develop the signs and symptoms of the disease, which can be exaggerated or life-threatening when associated with comorbidities like; obesity, sickle cell anemia, immune disorders, chromosomal abnormalities, chronic respiratory or cardiac problems, and congenital malformations.3 It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop obesity. It is a major health concern in this pandemic situation, which can be addressed and treated with the use of appropriate physical training and proper dietary habits.
详细描述
Children confirmed with COVID-19 infection have some systemic illness, that might lead to children with obesity. They are advised to perform regular physical training and consume a proper diet to prevent and treat negative consequences. Therefore, different obesity management and weight reduction protocols are developed to control and prevent health problems and socio-economic issues associated with obesity. The management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, there is a need for an elaborative trial in this field. Hence, the aim of this trial was to investigate and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low protein diet in community-dwelling COVID-19 infected children with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Positively diagnosed COVID-19 children
- •age group of 5 - 12 years
- •Body mass index (BMI) between 85th to 99th percentiles
排除标准
- •history of physical training,
- •taking medications,
- •recent surgeries,
- •fractures and joint problems in the lower extremity,
- •cardiac and respiratory problems,
- •neurological issues,
- •major psychiatric problems,
- •other systemic diseases,
- •contraindications for physical training and family with food restrictions
研究组 & 干预措施
High-intensity aerobic training with high protein diet - Group A
High-intensity aerobic training (HAT) was given at 50 to 70 percent of maximum heart rate. Subsequent to stretching, the subjects were asked to do 30 mins of HAT exercises; consisting of 20 mins on the treadmill and 10 mins on a cycle ergometer at 50 to 70 % of MHR, lastly, 10 mins of cool down was performed.
Next the participants, in this group A were prescribed with strength training exercises with resistance depending upon each subject's individual muscle assessment.
In addition to these physical training exercises, this group also received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d), as prescribed by a qualified nutritionist.
干预措施: High-intensity aerobic training with high protein diet (Other)
Control group - Group B
This group is considered a control group and they were allowed to follow their regular physical activities and dietary pattern.
干预措施: Control group (Other)
结局指标
主要结局
Body mass index (BMI)
时间窗: 6 months
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Body mass index (BMI)
时间窗: At baseline
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Body mass index (BMI)
时间窗: 8 weeks
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
次要结局
- Muscle cross sectional area - CSA(6 months.)
- Adiponectin(6 months)
- Leptin(6 months)
- TNF-α(6 months.)
- IL-6(6 months.)
- Muscle cross sectional area - CSA(At baseline)
- Muscle cross sectional area - CSA(8 weeks)
- Adiponectin(At baseline)
- Adiponectin(8 weeks)
- Leptin(At baseline)
- Leptin(8 weeks)
- TNF-α(At baseline)
- TNF-α(8 weeks)
- IL-6(At baseline)
- IL-6(8 weeks)
研究者
Gopal Nambi
Associate Professor
Prince Sattam Bin Abdulaziz University