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Clinical Trials/NCT04950725
NCT04950725CompletedNot Applicable

Covid-19 Virtual Recovery Study

Mayo Clinic2 sites in 1 country2,268 target enrollmentStarted: November 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Courtney M. Wheatley

Co-Principal Investigator

Mayo Clinic

Study Sites (2)

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