Personalized Exercise Rehabilitation for Pediatric and Adolescent Asthma: A Comprehensive Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Daily Physical Activity Level
研究概览
简要总结
Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Diagnosed with bronchial asthma;
- •No acute asthma attacks in the past three months;
- •Currently undergoing stable prophylactic treatment for asthma, with no changes in the treatment plan in the past three months.
排除标准
- •Suffering from other severe heart, lung, or musculoskeletal diseases;
- •Frequent acute asthma attacks or recent hospitalization records;
- •Changes in asthma medication treatment plan in the last three months;
- •Currently participating in other clinical trials that could affect the results of this study;
- •Any medical contraindications, such as severe exercise-induced asthma or other health issues affecting the ability to exercise;
- •Severe psychological or behavioral issues that may affect participation in training or adherence to the research protocol.
结局指标
主要结局
Daily Physical Activity Level
时间窗: up to 24 weeks
Daily Step Count (as measured by a pedometer), Energy Expenditure,Time Spent in Moderate-to-Vigorous Intensity Activity
Lung Function
时间窗: up to 24 weeks
Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1), Forced Expiratory Flow 25% to 75% (FEF25-75), Peak Expiratory Flow (PEF)
次要结局
- Asthma Control Status(up to 24 weeks)
- Fractional Exhaled Nitric Oxide (FeNO)(up to 12 weeks)
- Anxiety and Depression(up to 24 weeks)
- Body Composition(up to 24 weeks)
- Sleep(up to 24 weeks)
- Health Related Quality of Life(up to 24 weeks)
- Inflammatory Mediators(up to 12 weeks)
研究者
Nan Lin
Principal Investigator
The Children's Hospital of Zhejiang University School of Medicine