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临床试验/NCT04950725
NCT04950725已完成不适用

Covid-19 Virtual Recovery Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 2,268 人开始时间: 2021年11月1日最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Courtney M. Wheatley

Co-Principal Investigator

Mayo Clinic

研究点 (2)

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