Covid-19 Virtual Recovery Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 2,268
- Locations
- 2
- Primary Endpoint
- Change in Phonation time
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Phonation time
Time Frame: change from baseline to 4 weeks
Speaking/ speech sounds
Change in reported cognition
Time Frame: 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
Time Frame: change from baseline to 4 weeks
question asking to report presence of COVID-related symptoms
Change in reported affect of health on physical activity
Time Frame: 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
Time Frame: change from baseline to 4 weeks
How many times an individual can go from sitting to standing in one minute
Change in breathing difficulty
Time Frame: change from baseline to 4 weeks
rating how difficult breathing is from 1 very difficult to 5 no difficulty at all
Secondary Outcomes
No secondary outcomes reported
Investigators
Courtney M. Wheatley
Co-Principal Investigator
Mayo Clinic
