NCT04615052Unknown不适用
Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
研究概览
简要总结
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COVID-19
- •Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
- •Admitted in intensive care unit
排除标准
- •Cardiovascular disease
- •Resting dyspnea
- •Acute pulmonary embolism or pulmonary infarction
- •Deep venous thromboembolism
- •Uncontrolled visual or vestibular disorders
- •Pregnancy
- •Uncontrolled resting tachycardia
- •Uncontrolled hypertension
- •Uncontrolled Type II diabetes
- •Acute infections
- •Neurological disorders
- •Patients with chronic kidney disease who are in need of hemodialysis
- •Recent malignant neoplasm (<5 years)
- •Autoimmune diseases
- •Complex ventricular arrhythmias, atrial fibrillation or complete heart block
- •Transplant patients
- •Any physical disabilities that could hamper physical testing and exercise program
结局指标
主要结局
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
时间窗: Baseline and 16 weeks.
Higher score means better outcome.
次要结局
- Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on lipid profile at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on inflammatory cytokine IL-6 at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on fatigue assessed by Chalder scale at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on inflammatory cytokine IL-10 at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on insulin sensitivity at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on fatigue evaluated by the fatigue severity scale at one year.(Baseline and one year.)
- Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on C-reactive Protein at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on body weight at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.(Baseline and 16 weeks.)
- Change from baseline on inflammatory cytokine IL-1 at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on waist circumference at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on hip circumference at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.(Baseline and one year.)
- Change from baseline on Creatine Kinase at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on muscular strength assessed by handgrip test at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on fatigue assessed by Chalder scale at one year.(Baseline and one year.)
- Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.(Baseline and one year.)
- Change from baseline on muscular strength assessed by handgrip test at one year.(Baseline and one year.)
- Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.(Baseline and 16 weeks.)
- Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.(Baseline and one year.)
- Change from baseline on muscular function assessed by Timed-Stand Test at one year.(Baseline and one year.)
- Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.(Baseline and one year.)
研究者
Bruno Gualano
Professor
University of Sao Paulo
研究点 (2)
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