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Covid-19 Virtual Recovery Study

Not Applicable
Completed
Conditions
Covid19
Interventions
Behavioral: Low dose RMT
Behavioral: Endurance RMT and nasal breathing
Behavioral: Strength RMT
Behavioral: Strength RMT and nasal breathing
Behavioral: Endurance RMT
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2268
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Low respiratory muscle trainingLow dose RMTLow dose of RMT and fewer repetitions and use of RMT device per week
Respiratory muscle training for endurance and nasal breathingEndurance RMT and nasal breathingOne set of RMT with a higher number of repetitions accompanied with sets of nasal breathing
Respiratory muscle training for strengtheningStrength RMTHigher number of sets with a slightly lower number of repetitions per set
Respiratory muscle training for strengthening and nasal breathingStrength RMT and nasal breathingHigher number of sets with a slightly lower number of repetitions per set RMT accompanied with sets of nasal breathing
Respiratory muscle training for enduranceEndurance RMTOne set of RMT with a higher number of repetitions
Primary Outcome Measures
NameTimeMethod
Change in reported cognitionchange 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 Phonation timechange from baseline to 4 weeks

Speaking/ speech sounds

Change in number of reported COVID symptomschange from baseline to 4 weeks

question asking to report presence of COVID-related symptoms

Change in reported affect of health on physical activitychange from baseline to 4 weeks

rating of affect from 1 affects me severely to 5 not at all affected

Change in Sit to stand executionschange from baseline to 4 weeks

How many times an individual can go from sitting to standing in one minute

Change in breathing difficultychange from baseline to 4 weeks

rating how difficult breathing is from 1 very difficult to 5 no difficulty at all

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Arizona

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Scottsdale, Arizona, United States

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