Covid-19 Virtual Recovery Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Covid-19 Virtual Recovery Study

Conditions
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Covid19

Intervention / Treatment
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* Behavioral: Strength RMT
* Behavioral: Strength RMT and nasal breathing
* Behavioral: Endurance RMT
* Behavioral: Endurance RMT and nasal breathing
* Behavioral: Low dose RMT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low respiratory muscle training<br>Low dose of RMT and fewer repetitions and use of RMT device per week | Behavioral: Low dose RMT<br>* 10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.<br>|
| Experimental: Respiratory muscle training for strengthening<br>Higher number of sets with a slightly lower number of repetitions per set | Behavioral: Strength RMT<br>* 2 sets of 10 breaths twice per day using the breather or 3 sets of 10 breaths, twice per day using the Breather Fit<br>|
| Experimental: Respiratory muscle training for strengthening and nasal breathing<br>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<br>* 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.<br>|
| Experimental: Respiratory muscle training for endurance<br>One set of RMT with a higher number of repetitions | Behavioral: Endurance RMT<br>* 15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit<br>|
| Experimental: Respiratory muscle training for endurance and nasal breathing<br>One set of RMT with a higher number of repetitions accompanied with sets of nasal breathing | Behavioral: Endurance RMT and nasal breathing<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory muscle training, Covid-19, Long Hauler Syndrome, Long Covid, Nasal breathing