Covid-19 Virtual Recovery Study

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Behavioral: Low dose RMT; Behavioral: Strength RMT; Behavioral: Strength RMT and nasal breathing; Behavioral: Endurance RMT; Behavioral: Endurance RMT and nasal breathing

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 Type: Interventional
• Enrollment (Actual): 2268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meredith Shea, PhD; Phone Number: 480-301-60211; Email: shea.meredith@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low respiratory muscle training; Low dose of RMT and fewer repetitions and use of RMT device per week	Behavioral: Low dose RMT; 10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
Experimental: Respiratory muscle training for strengthening; Higher number of sets with a slightly lower number of repetitions per set	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
Experimental: 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	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.
Experimental: Respiratory muscle training for endurance; One set of RMT with a higher number of repetitions	Behavioral: Endurance RMT; 15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
Experimental: Respiratory muscle training for endurance and nasal breathing; One set of RMT with a higher number of repetitions accompanied with sets of nasal breathing	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Phonation time	Speaking/ speech sounds	change from baseline to 4 weeks
Change in Sit to stand executions	How many times an individual can go from sitting to standing in one minute	change from baseline to 4 weeks
Change in number of reported COVID symptoms	question asking to report presence of COVID-related symptoms	change from baseline to 4 weeks
Change in breathing difficulty	rating how difficult breathing is from 1 very difficult to 5 no difficulty at all	change from baseline to 4 weeks
Change in reported affect of health on physical activity	rating of affect from 1 affects me severely to 5 not at all affected	change from baseline to 4 weeks
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	change from baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Courtney M Wheatley-Guy, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Covid-19; Long Covid; Respiratory muscle training; Long Hauler Syndrome; Nasal breathing
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 21-000953

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No