Clinical trial NCT04950725: Covid-19 Virtual Recovery Study
Official title: Covid-19 Virtual Recovery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Respiratory muscle training
Covid-19
Long Hauler Syndrome
Long Covid
Nasal breathing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 2268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Phonation time
timeFrame: change from baseline to 4 weeks
measure: Change in Sit to stand executions
timeFrame: change from baseline to 4 weeks
measure: Change in number of reported COVID symptoms
timeFrame: change from baseline to 4 weeks
measure: Change in breathing difficulty
timeFrame: change from baseline to 4 weeks
measure: Change in reported affect of health on physical activity
timeFrame: change from baseline to 4 weeks
measure: Change in reported cognition
timeFrame: change from baseline to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Courtney M Wheatley-Guy, PhD
role: PRINCIPAL_INVESTIGATOR
References: