Covid-19 Virtual Recovery Study

Mayo Clinic

Status: Completed

Conditions: Covid19

Treatments: Behavioral: Endurance RMT; Behavioral: Endurance RMT and nasal breathing; Behavioral: Strength RMT and nasal breathing; Behavioral: Strength RMT; Behavioral: Low dose RMT

Study type: Interventional

Funder types: Other

Identifiers

NCT04950725

21-000953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,268 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,268 participants in 5 patient groups

Low respiratory muscle training

Experimental group

Description:

Low dose of RMT and fewer repetitions and use of RMT device per week

Treatment:

Behavioral: Low dose RMT

Respiratory muscle training for strengthening

Experimental group

Description:

Higher number of sets with a slightly lower number of repetitions per set

Treatment:

Behavioral: Strength RMT

Respiratory muscle training for strengthening and nasal breathing

Experimental group

Description:

Higher number of sets with a slightly lower number of repetitions per set RMT accompanied with sets of nasal breathing

Treatment:

Behavioral: Strength RMT and nasal breathing

Respiratory muscle training for endurance

Experimental group

Description:

One set of RMT with a higher number of repetitions

Treatment:

Behavioral: Endurance RMT

Respiratory muscle training for endurance and nasal breathing

Experimental group

Description:

One set of RMT with a higher number of repetitions accompanied with sets of nasal breathing

Treatment:

Behavioral: Endurance RMT and nasal breathing