Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Safety and efficacy of a home-based exercise training program
研究概览
简要总结
Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.
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
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with either one of the following chronic conditions:
- •Inflammatory bowel disease;
- •autoimmune hepatitis;
- •liver transplant;
- •renal transplant;
- •systemic lupus erythematosus;
- •juvenile dermatomyositis;
- •juvenile idiopathic arthritis.
排除标准
- •Patients with physical limitations that preclude exercise.
- •Patients diagnosed with COVID-
- •Patients diagnosed with mental disorders.
结局指标
主要结局
Safety and efficacy of a home-based exercise training program
时间窗: From baseline to 3 months of follow-up
Semi structured interview
次要结局
- Patients perceptions during social isolation(From baseline to 3 months of follow-up)
- Adolescents quality of life(From baseline to 3 months of follow-up)
- Disease activity(From baseline to 3 months of follow-up)
- Disease overall assessment(From baseline to 3 months of follow-up)
- Strengths and difficulties(From baseline to 3 months of follow-up)
研究者
Bruno Gualano
Dr
University of Sao Paulo