Covid19NCT04950725
Covid-19 Virtual Recovery Study
A study testing Strength RMT, Strength RMT and nasal breathing and Endurance RMT in people with Covid19, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Strength RMT, Strength RMT and nasal breathing and Endurance RMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,268 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Positive test for SARS-CoV2 within the last 3 months.
- Smartphone user.
- English speaker.
- Age 18 or above.
- US resident.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Strength RMT, Strength RMT and nasal breathing, Endurance RMT, Endurance RMT and nasal breathing, Low dose RMT
- Keywords
- Respiratory muscle training, Covid-19, Long Hauler Syndrome, Long Covid, Nasal breathing
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength RMTBehavioural
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 breathingBehavioural
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 RMTBehavioural
15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
Endurance RMT and nasal breathingBehavioural
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 RMTBehavioural
10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
| Study group | Role | What they receive |
|---|---|---|
| Low respiratory muscle training | Experimental | Low dose of RMT and fewer repetitions and use of RMT device per week Receives: Behavioral: Low dose RMT |
| Respiratory muscle training for strengthening | Experimental | Higher number of sets with a slightly lower number of repetitions per set Receives: 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 Receives: Behavioral: Strength RMT and nasal breathing |
| Respiratory muscle training for endurance | Experimental | One set of RMT with a higher number of repetitions Receives: 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 Receives: Behavioral: Endurance RMT and nasal breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Phonation time
Speaking/ speech sounds
Measured: 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
Measured: change from baseline to 4 weeks
Change in number of reported COVID symptoms
question asking to report presence of COVID-related symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M. Wheatley, Mayo Clinic
- Investigators
- Courtney M Wheatley-Guy, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950725
- Sponsor's protocol ID
- 21-000953
- Status last verified
- Aug 2023
- First submitted
- 30 Jun 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Virtual Recovery Study
- ClinicalTrials.gov ID
- NCT04950725
- Acronym / sponsor ID
- 21-000953
- Conditions
- Covid19
- Keywords
- Respiratory muscle training, Covid-19, Long Hauler Syndrome, Long Covid, Nasal breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,268 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low respiratory muscle training | Experimental | Behavioral: Low dose RMTLow dose of RMT and fewer repetitions and use of RMT device per week |
| Respiratory muscle training for strengthening | Experimental | Behavioral: Strength RMTHigher number of sets with a slightly lower number of repetitions per set |
| Respiratory muscle training for strengthening and nasal breathing | Experimental | Behavioral: Strength RMT and nasal breathingHigher number of sets with a slightly lower number of repetitions per set RMT accompanied with sets of nasal breathing |
| Respiratory muscle training for endurance | Experimental | Behavioral: Endurance RMTOne set of RMT with a higher number of repetitions |
| Respiratory muscle training for endurance and nasal breathing | Experimental | Behavioral: Endurance RMT and nasal breathingOne set of RMT with a higher number of repetitions accompanied with sets of nasal breathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive test for SARS-CoV2 within the last 3 months.
- Smartphone user.
- English speaker.
- Age 18 or above.
- US resident.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength RMT2 sets of 10 breaths twice per day using the breather or 3 sets of 10 breaths, twice per day using the Breather Fit | Behavioural | Respiratory muscle training for strengthening |
| Strength RMT and nasal breathing2 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. | Behavioural | Respiratory muscle training for strengthening and nasal breathing |
| Endurance RMT15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit | Behavioural | Respiratory muscle training for endurance |
| Endurance RMT and nasal breathing15 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. | Behavioural | Respiratory muscle training for endurance and nasal breathing |
| Low dose RMT10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device. | Behavioural | Low respiratory muscle training |
Primary outcome
Change in Phonation time
Time frame: change from baseline to 4 weeks
Speaking/ speech sounds
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
Change in number of reported COVID symptoms
Time frame: change from baseline to 4 weeks
question asking to report presence of COVID-related symptoms
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney M Wheatley-Guy, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength RMT, Strength RMT and nasal breathing and Endurance RMT in people with Covid19, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Phonation time (time frame: change from baseline to 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.