Covid-19 Virtual Recovery Study

Not Applicable

Completed

• Conditions: Covid19

• Registration Number: NCT04950725
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-06
• Study Start: 2021-11-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2268

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Phonation time	change from baseline to 4 weeks	Speaking/ speech sounds
Change in reported cognition	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	change from baseline to 4 weeks	question asking to report presence of COVID-related symptoms
Change in reported affect of health on physical activity	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	change from baseline to 4 weeks	How many times an individual can go from sitting to standing in one minute
Change in breathing difficulty	change from baseline to 4 weeks	rating how difficult breathing is from 1 very difficult to 5 no difficulty at all

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States