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Covid-19 Virtual Recovery Study

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength RMT
Strength RMT and nasal breathing
Endurance RMT
Endurance RMT and nasal breathing
Low dose RMT
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Covid19 focused on measuring Respiratory muscle training, Covid-19, Long Hauler Syndrome, Long Covid, Nasal breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Positive test for SARS-CoV2 within the last 3 months.
  • Smartphone user.
  • English speaker.
  • Age 18 or above.
  • US resident.

Exclusion criteria:

  • Hemodynamic instability.
  • Contraindications or inability to perform RMT.
  • Inability to navigate study questionnaires or tasks.
  • History of kidney disease, arteriosclerosis obliterans, and high calcium levels.

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Low respiratory muscle training

Respiratory muscle training for strengthening

Respiratory muscle training for strengthening and nasal breathing

Respiratory muscle training for endurance

Respiratory muscle training for endurance and nasal breathing

Arm Description

Low dose of RMT and fewer repetitions and use of RMT device per week

Higher number of sets with a slightly lower number of repetitions per set

Higher number of sets with a slightly lower number of repetitions per set RMT accompanied with sets of nasal breathing

One set of RMT with a higher number of repetitions

One set of RMT with a higher number of repetitions accompanied with sets of nasal breathing

Outcomes

Primary Outcome Measures

Change in Phonation time
Speaking/ speech sounds
Change in Sit to stand executions
How many times an individual can go from sitting to standing in one minute
Change in number of reported COVID symptoms
question asking to report presence of COVID-related symptoms
Change in breathing difficulty
rating how difficult breathing is from 1 very difficult to 5 no difficulty at all
Change in reported affect of health on physical activity
rating of affect from 1 affects me severely to 5 not at all affected
Change in reported cognition
summary score of memory, alertness, sadness, anxiety and focus getting better (1), worse (-1) or no change (0) where higher score equals more improvement

Secondary Outcome Measures

Full Information

First Posted
June 30, 2021
Last Updated
August 18, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04950725
Brief Title
Covid-19 Virtual Recovery Study
Official Title
Covid-19 Virtual Recovery Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Respiratory muscle training, Covid-19, Long Hauler Syndrome, Long Covid, Nasal breathing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low respiratory muscle training
Arm Type
Experimental
Arm Description
Low dose of RMT and fewer repetitions and use of RMT device per week
Arm Title
Respiratory muscle training for strengthening
Arm Type
Experimental
Arm Description
Higher number of sets with a slightly lower number of repetitions per set
Arm Title
Respiratory muscle training for strengthening and nasal breathing
Arm Type
Experimental
Arm Description
Higher number of sets with a slightly lower number of repetitions per set RMT accompanied with sets of nasal breathing
Arm Title
Respiratory muscle training for endurance
Arm Type
Experimental
Arm Description
One set of RMT with a higher number of repetitions
Arm Title
Respiratory muscle training for endurance and nasal breathing
Arm Type
Experimental
Arm Description
One set of RMT with a higher number of repetitions accompanied with sets of nasal breathing
Intervention Type
Behavioral
Intervention Name(s)
Strength RMT
Intervention Description
2 sets of 10 breaths twice per day using the breather or 3 sets of 10 breaths, twice per day using the Breather Fit
Intervention Type
Behavioral
Intervention Name(s)
Strength RMT and nasal breathing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Endurance RMT
Intervention Description
15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
Intervention Type
Behavioral
Intervention Name(s)
Endurance RMT and nasal breathing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low dose RMT
Intervention Description
10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
Primary Outcome Measure Information:
Title
Change in Phonation time
Description
Speaking/ speech sounds
Time Frame
change from baseline to 4 weeks
Title
Change in Sit to stand executions
Description
How many times an individual can go from sitting to standing in one minute
Time Frame
change from baseline to 4 weeks
Title
Change in number of reported COVID symptoms
Description
question asking to report presence of COVID-related symptoms
Time Frame
change from baseline to 4 weeks
Title
Change in breathing difficulty
Description
rating how difficult breathing is from 1 very difficult to 5 no difficulty at all
Time Frame
change from baseline to 4 weeks
Title
Change in reported affect of health on physical activity
Description
rating of affect from 1 affects me severely to 5 not at all affected
Time Frame
change from baseline to 4 weeks
Title
Change in reported cognition
Description
summary score of memory, alertness, sadness, anxiety and focus getting better (1), worse (-1) or no change (0) where higher score equals more improvement
Time Frame
change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Positive test for SARS-CoV2 within the last 3 months. Smartphone user. English speaker. Age 18 or above. US resident. Exclusion criteria: Hemodynamic instability. Contraindications or inability to perform RMT. Inability to navigate study questionnaires or tasks. History of kidney disease, arteriosclerosis obliterans, and high calcium levels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney M Wheatley-Guy, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Covid-19 Virtual Recovery Study

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