Covid-19 Virtual Recovery Study

NCT04950725 | Completed

• 1 other identifier: 21-000953
• Study Type: interventional
• Target: 2,268
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Respiratory muscle training; Covid-19; Long Hauler Syndrome; Long Covid; Nasal breathing

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (5)

Low respiratory muscle training

EXPERIMENTAL

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

Behavioral: Low dose RMT

Respiratory muscle training for strengthening

EXPERIMENTAL

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

Behavioral: Strength RMT

Respiratory muscle training for strengthening and nasal breathing

EXPERIMENTAL

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

Respiratory muscle training for endurance

EXPERIMENTAL

One set of RMT with a higher number of repetitions

Behavioral: Endurance RMT

Respiratory muscle training for endurance and nasal breathing

EXPERIMENTAL

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

Behavioral: Endurance RMT and nasal breathing

Interventions

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

Respiratory muscle training for strengthening

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.

Respiratory muscle training for strengthening and nasal breathing

Endurance RMT BEHAVIORAL

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

Respiratory muscle training for endurance

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.

Respiratory muscle training for endurance and nasal breathing

Low dose RMT BEHAVIORAL

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

Low respiratory muscle training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive test for SARS-CoV2 within the last 3 months.
• Smartphone user.
• English speaker.
• Age 18 or above.
• US resident.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Courtney M Wheatley-Guy, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 6, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)