Covid19
Conditions
Keywords
Respiratory muscle training, Covid-19, Long Hauler Syndrome, Long Covid, Nasal breathing
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.
Interventions
BEHAVIORALStrength 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
BEHAVIORALStrength 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.
BEHAVIORALEndurance RMT
15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
BEHAVIORALEndurance 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.
BEHAVIORALLow dose RMT
10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Phonation time | change from baseline to 4 weeks | Speaking/ speech sounds |
| Change in Sit to stand executions | change from baseline to 4 weeks | How many times an individual can go from sitting to standing in one minute |
| Change in number of reported COVID symptoms | change from baseline to 4 weeks | question asking to report presence of COVID-related symptoms |
| Change in breathing difficulty | change from baseline to 4 weeks | rating how difficult breathing is from 1 very difficult to 5 no difficulty at all |
| Change in reported affect of health on physical activity | change from baseline to 4 weeks | rating of affect from 1 affects me severely to 5 not at all affected |
| Change in reported cognition | 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 |
Countries
United States
Outcome results
None listed