NCT05360563Unknown不适用
Effects of a Home-based Exercise Program on the Functional Sequelae of Patients With the Post-COVID-19 Condition: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
研究概览
简要总结
The management of the sequelae of COVID-19 is described as the next great challenge of global public health. Multiple symptoms may compose the clinical picture of these patients (eg, fatigue, dyspnea, cognitive dysfunction, myalgia and others), persisting for more than a year and frequently causing clinically important functional impairment. Thus, a clinical trial will be conducted to investigate the effects of a remotely supervised home-based exercise program on functional sequelae of patients diagnosed with the post-COVID-19 condition (also known as Long COVID).
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 diagnostic history confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) or rapid antigen test (with clinical presentations of moderate to critical severity).
- •Diagnosis of post-COVID-19 condition according to World Health Organization criteria.
- •Present ≥1 symptoms at study admission, including dyspnea, fatigue, muscle weakness and/or musculoskeletal pain.
- •Have internet access at home.
排除标准
- •Being under clinical or experimental treatment for the post-COVID-19 condition.
- •Any physical disabilities that could hamper physical testing and exercise program.
- •Patients with major neuropsychiatric disorders (eg, dementia or severe depression).
- •Patients with chronic kidney disease who are in need of hemodialysis.
- •Solid organ transplant patients.
- •Complex ventricular arrhythmias, atrial fibrillation or complete heart block.
- •Recent malignant neoplasm.
- •Recent deep venous thromboembolism.
- •Acute pulmonary embolism or pulmonary infarction.
- •Uncontrolled hypertension.
- •Uncontrolled type II diabetes.
- •Uncontrolled vestibular disorders.
- •Acute infections.
- •Pregnancy.
研究组 & 干预措施
Physical training group
Experimental
In addition to receive regular medical care, the physical training group will participate in a tailored home-based exercise program (remotely supervised by healthcare professionals).
干预措施: Home-based physical training (Other)
Control group
No Intervention
The control group will receive regular medical care.
结局指标
主要结局
Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
时间窗: At baseline and after 16 weeks
Higher score means better outcome.
次要结局
- Change from baseline in waist circumference (cm) at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in muscle function (number of repetitions) assessed by the 1-minute sit-to-stand test (1'STST) at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in physical activity levels (min/week of MVPA) assessed by the international physical activity questionnaires (IPAQ) at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in fatigue levels (from 0 to 33 points) assessed by the Chalder fatigue scale (CFQ) at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in learning and memory (z-score) assessed in a battery of cognitive tests at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in hip circumference (cm) at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in functional capacity (from 0 to 4 degrees of functional limitation) assessed by the post-COVID-19 functional status (PCFS) scale at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.(At baseline and after 16 weeks)
- Change from baseline in total body weight (kg) at 16 weeks.(At baseline and after 16 weeks)
研究者
Bruno Gualano
Professor
University of Sao Paulo
研究点 (1)
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