Covid-19 Virtual Recovery Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 2,268
- 试验地点
- 2
- 主要终点
- Change in Phonation time
研究概览
简要总结
The purpose of this study is to determine the effects of respiratory muscle training (RMT) and nasal breathing on patients who have been infected with the SARS-CoV2 virus and continue to have lingering symptoms.
详细描述
This study will be conducted virtually and will be completed at home using a cell phone application. Study participation involves the use of a RMT device, and/or nasal breathing. The purpose of this research is to evaluate the impact of RMT and nasal breathing on chronic symptoms of COVID-19 in patients that have recovered from SARS-CoV2.
Subjects that have tested positive for the SARS-CoV2 infection and have completed a 14 to 30 day quarantine will be recruited.The RMT device will be used up to 2 times a day at a moderate intensity for 2 or 3 sets of 10 or 15 repetitions. Additionally, 2 sets of 10 nasal breathing techniques will be performed twice a day without the RMT device.
Subjects will complete several surveys examining symptoms, physical activity, cognitive function, and quality of life at baseline, 2 weeks, and 4 weeks. Subjects will also perform phonation (speaking/speech sounds) and sit to stand tests at baseline, 2 weeks, and 4 weeks. All data will be collected through the use of a cell phone application. The cell phone application will also provide subjects with the proper RMT protocol. Additionally, subjects will receive coaching and instructions on how to use the breathing device, as well as instructions on how to complete the phonation and sit to stand test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Phonation time
时间窗: change from baseline to 4 weeks
Speaking/ speech sounds
Change in reported cognition
时间窗: change from baseline to 4 weeks
summary score of memory, alertness, sadness, anxiety and focus getting better (1), worse (-1) or no change (0) where higher score equals more improvement
Change in number of reported COVID symptoms
时间窗: change from baseline to 4 weeks
question asking to report presence of COVID-related symptoms
Change in reported affect of health on physical activity
时间窗: change from baseline to 4 weeks
rating of affect from 1 affects me severely to 5 not at all affected
Change in Sit to stand executions
时间窗: change from baseline to 4 weeks
How many times an individual can go from sitting to standing in one minute
Change in breathing difficulty
时间窗: change from baseline to 4 weeks
rating how difficult breathing is from 1 very difficult to 5 no difficulty at all
次要结局
未报告次要终点
研究者
Courtney M. Wheatley
Co-Principal Investigator
Mayo Clinic
