NCT04950725

Covid-19 Virtual Recovery Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,268 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BEHAVIORAL	Strength RMT	2 sets of 10 breaths twice per day using the breather or 3 sets of 10 breaths, twice per day using the Breather Fit
BEHAVIORAL	Strength RMT and nasal breathing	2 sets of 10 breaths twice per day using the Breather or 3 sets of 10 breaths twice per day using the Breather Fit. Subjects will also be asked to complete 2 sets of 10 nasal breathing exercises either before or after the RMT exercise.
BEHAVIORAL	Endurance RMT	15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
BEHAVIORAL	Endurance RMT and nasal breathing	15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit at a lower intensity for a longer duration without break. Subjects will also perform 2 sets of 10 nasal breathing exercises either before or after the RMT exercise.
BEHAVIORAL	Low dose RMT	10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-31
• Completion: 2023-07-01
• First posted: 2021-07-06
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States