Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2268 participants
INTERVENTIONAL
2021-11-01
2023-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Low respiratory muscle training
Low dose of RMT and fewer repetitions and use of RMT device per week
Low dose RMT
10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
Respiratory muscle training for strengthening
Higher number of sets with a slightly lower number of repetitions per set
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
Respiratory muscle training for strengthening and nasal breathing
Higher number of sets with a slightly lower number of repetitions per set RMT accompanied with sets of nasal breathing
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.
Respiratory muscle training for endurance
One set of RMT with a higher number of repetitions
Endurance RMT
15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
Respiratory muscle training for endurance and nasal breathing
One set of RMT with a higher number of repetitions accompanied with sets of nasal breathing
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.
Interventions
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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
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.
Endurance RMT
15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
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.
Low dose RMT
10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
Eligibility Criteria
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Inclusion Criteria
* Smartphone user.
* English speaker.
* Age 18 or above.
* US resident.
Exclusion Criteria
* Contraindications or inability to perform RMT.
* Inability to navigate study questionnaires or tasks.
* History of kidney disease, arteriosclerosis obliterans, and high calcium levels.
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Courtney M. Wheatley
Co-Principal Investigator
Principal Investigators
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Courtney M Wheatley-Guy, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-000953
Identifier Type: -
Identifier Source: org_study_id
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