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Completed

NCT Number: NCT04950725

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.

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Key information

Conditions

Covid19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strength RMT

Behavioral

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

Behavioral

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

Behavioral

15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit

Endurance RMT and nasal breathing

Behavioral

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

Behavioral

10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.

Primary outcomes

  1. Change in Phonation time

    Time frame: change from baseline to 4 weeks

    Speaking/ speech sounds

  2. Change in Sit to stand executions

    Time frame: change from baseline to 4 weeks

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

  3. Change in number of reported COVID symptoms

    Time frame: change from baseline to 4 weeks

    question asking to report presence of COVID-related symptoms

  4. Change in breathing difficulty

    Time frame: change from baseline to 4 weeks

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

  5. Change in reported affect of health on physical activity

    Time frame: change from baseline to 4 weeks

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

  6. Change in reported cognition

    Time frame: change 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 6, 2021
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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