Effectiveness of a High-intensity Intervallic Training Program in Children and Adolescents With Post-infectious Bronchiolitis Obliterans: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Change in peak oxygen consumption
研究概览
简要总结
Post-Infectious Bronchiolitis Obliterans (PIBO) is an irreversible obstructive lung disease characterized by subepithelial inflammation and fibrotic narrowing of the bronchioles after lower respiratory tract infection. This disease is diagnosed mainly in children, more frequently before the age of 2 years. Due to symptoms such as dry cough and dyspnea sensation, most of these patients have low levels of physical activity compared to healthy individuals. Physical activity can positively influence oxygen consumption, muscle strength, and quality of life. High levels of oxygen consumption are associated with a lower risk of respiratory disease and hospitalization. High-intensity interval training (HIIT) may be an effective way to improve oxygen consumption, muscle strength, and quality of life in patients with chronic diseases. HIIT has been shown to produce less dyspnea sensation and to be more entertaining in children and adolescents with respiratory disease compared to continuous training. Thus, the investigators propose to perform telematically real-time guided training to reduce travel times and additional costs to patients.
Objective: To analyze the effects of a telematically supervised high-intensity intervallic training program on aerobic fitness, as well as functional/clinical outcomes in patients with PIBO.
Methods: Randomized controlled trial with two groups. Exercise group: 16-week HIIT training conducted telematically; Control group: will follow the routine physician's recommendations. Patients will be recruited at Vall D'Hebrón University Hospital (Barcelona), Niño Jesús University Hospital (Madrid), and Donostia Universitary Hospital (San Sebastián). Criteria for participation: (I) Diagnosis of PIBO; (II) Clinically stable at the time of the assessments; (III) Age between 6 to 20 years old.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
The evaluators and care providers will be masked to the allocation of the patients. Given the nature of the intervention, it is not possible to mask patients or monitors in charge of supervising the execution of the exercise training.
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Postinfectious bronchiolitis obliterans;
- •Clinical stability at the time of the assessments;
- •Age between 6 and 20 years old.
排除标准
- •Symptoms of pulmonary exacerbation during the last four weeks;
- •Diagnosis of other cardiorespiratory diseases leading to symptoms of persistent respiratory dysfunction;
- •Difficulty in comprehension or musculoskeletal alterations that may influence the assessments;
- •Pregnancy;
- •Transplant list inclusion.
结局指标
主要结局
Change in peak oxygen consumption
时间窗: Change from baseline to 16 weeks
Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET).
Change in time to ventilatory threshold
时间窗: Change from baseline to 16 weeks
Change in time to ventilatory threshold (minutes) will be evaluated through cardiopulmonary exercise testing (CPET).
Change in percent oxygen consumption at ventilatory threshold
时间窗: Change from baseline to 16 weeks
Change in percent oxygen consumption at ventilatory threshold will be evaluated through cardiopulmonary exercise testing (CPET).
Change in ventilatory efficiency
时间窗: Change from baseline to 16 weeks
Change in ventilatory efficiency will be evaluated by combining ventilation (VE) and carbon dioxide production (VCO2) measurements to report VE/VCO2 ratio, evaluated through cardiopulmonary exercise testing (CPET).
次要结局
- Change in forced vital capacity(Change from baseline to 16 weeks)
- Change in forced expiratory flow between 25 and 75% of forced vital capacity(Change from baseline to 16 weeks)
- Change in free fat mass(Change from baseline to 16 weeks)
- Change in body mass index(Change from baseline to 16 weeks)
- Change in dyspnea(Change from baseline to 16 weeks)
- Change in muscle strength(Change from baseline to 16 weeks)
- Change in lower body strength(Change from baseline to 16 weeks)
- Change in lean mass(Change from baseline to 16 weeks)
- Change in hip-waist ratio(Change from baseline to 16 weeks)
- Change in forced expiratory volume in the first second(Change from baseline to 16 weeks)
- Change in quality of life(Change from baseline to 16 weeks)
研究者
Márcio Vinícius Fagundes Donadio
Professor
Universitat Internacional de Catalunya