Post-COVID-19 SyndromeNCT06091280
Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
A study testing Respiratory Muscle Strength Trainers in people with Post-COVID-19 Syndrome and Dyspnea, run by University of South Florida at 1 site in United States.
Trial summary
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Dyspnea
- What is being tested?
- Respiratory Muscle Strength Trainers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 14 Mar 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported history of a positive COVID-19 diagnosis in the past.
- Able to walk independently
- Cognitively intact
- English-speaking
- Dyspnea at rest or with activity rated at 3 or greater on the Dyspnea on Exertion scale.
- May use oxygen.
- May be taking medications.
Who cannot join
- Individuals who are wheelchair bound or who cannot walk independently.
- Individuals hospitalized for COVID-19 who self-report that they received mechanical ventilation during hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those who are experiencing persistent shortness of breath after having had COVID-19. Measurements will take place at the beginning, 6 weeks, and at 12 weeks in the study.
Read the detailed description
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory muscle strength training exercises as compared to a prior study of expiratory muscle strength training alone is effective in improving dyspnea, respiratory symptoms, quantitative measures of pulmonary function, physical performance, and quality of life in individuals reporting persistent dyspnea post-COVID-19 at baseline, six and twelve weeks.
- Conditions
- Post-COVID-19 Syndrome, Dyspnea
- Being tested
- Respiratory Muscle Strength Trainers
- Keywords
- Respiratory muscle strength training, Respiratory symptoms
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Dyspnea, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle Strength TrainersDevice
Also called Threshold Inspiratory Muscle Strength Trainer, Expiratory Muscle Strength Trainer (EMST 150)
Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Muscle Strength Training | Experimental | Pursed Lip Breathing: Participants will perform two sets of 10 repetitions twice per day.
Inspiratory Muscle Strength Training (IMST): The participant will use an IMST trainer provided by the study (Threshold Inspiratory Muscle Strength Trainer). This exercise is repeated for a 3-minute duration, followed by a rest period of 2 minutes. This cycle is repeated for 6 cycles over a 30-minute timespan. This exercise will be performed 3 times/week on alternating days.
Expiratory Muscle Strength Training (EMST): The participant will use an EMST trainer (EMST 150) provided by the study. This exercise is repeated for a 3-minute duration, followed by a rest period of 2 minutes. The cycle is repeated for 6 cycles over a 30-minute timespan. This exercise will be performed 3 x/week on opposite days of the inspiratory muscle strength training. Receives: Device: Respiratory Muscle Strength Trainers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council Scale
Scale of 0-4 with 4 being the most severe dyspnea.
Measured: Baseline, 6-weeks, and 12-week measurements
COPD Assessment Test
8-item questionnaire with a semantic, 6-point differential scale for each item. Scores range from 0-40 with higher scores indicating more severe respiratory symptoms.
Measured: Baseline, 6-weeks, and 12-week measurements.
Forced Expiratory Volume over 1 second (FEV1)
Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).
Measured: Baseline, 6-weeks, and 12-week measurements
Peak Inspiratory Flow
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
Measured: Baseline, 6-weeks, and 12-week measurements.
Thoracic Expansion Measures
Gulick tape measure positioned around the participant's chest at the 4th intercostal space. Participant breathes in and out as far as possible and the difference between the 2 values equals thoracic expansion.
Measured: Baseline, 6-weeks, and 12-week measurements
Physical Capacity
6 Minute Walk Test following the American Thoracic Society Procedure: 50-meter distance is marked. Participant walks as quickly as possible for 6 minutes. Results recorded in meters. Vital signs and oxygen saturation monitored and recorded.
Measured: Baseline, 6-weeks, and 12-week measurements.
EuroQoL-5 Dimension-5 Level
EuroQoL-5 Dimension-5 Level to evaluate 5 dimensions of quality of life including mobility, self-care, usual activities, discomfort and pain, anxiety, and depression. Each is scored using a 5-point semantic scale.
Measured: Baseline, 6-weeks, and 12-week measurements.
Secondary outcomes (1)
Feasibility and Acceptability of the Intervention
Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.
Measured: 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Dec 2023
- Primary completion23 Dec 2024
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, longitudinal, intervention study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constance Visovsky, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091280
- Sponsor's protocol ID
- 006272
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be available at the end of the study to other investigators and will include the data associated with the study outcomes (Dyspnea, quality of life, pulmonary symptoms, thoracic expansion, pulmonary function tests, six minute walk test, demographics, and feasibility and acceptability).
Publications
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
PubMed 3342669Morgan S, Visovsky C, Thomas B, Klein AB, Ji M, Schwab L, Coury J. Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19. Clin Nurs Res. 2023 Jun;32(5):895-901. doi: 10.1177/10547738231170496. Epub 2023 May 3.
PubMed 37132243Mota S, Guell R, Barreiro E, Solanes I, Ramirez-Sarmiento A, Orozco-Levi M, Casan P, Gea J, Sanchis J. Clinical outcomes of expiratory muscle training in severe COPD patients. Respir Med. 2007 Mar;101(3):516-24. doi: 10.1016/j.rmed.2006.06.024. Epub 2006 Aug 30.
PubMed 16942867Morgan SP, Thomas B, Rodriguez CS, Johnson A, Beckie TM. Inspiratory and Expiratory Muscle Strength Training for Persistent Dyspnea in Post-COVID-19. Clin Nurs Res. 2025 Nov;34(8):462-471. doi: 10.1177/10547738251371244. Epub 2025 Sep 25.
PubMed 40995943
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
- ClinicalTrials.gov ID
- NCT06091280
- Acronym / sponsor ID
- 006272
- Conditions
- Post-COVID-19 Syndrome, Dyspnea
- Keywords
- Respiratory muscle strength training, Respiratory symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 19 Oct 2023 (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.
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those who are experiencing persistent shortness of breath after having had COVID-19. Measurements will take place at the beginning, 6 weeks, and at 12 weeks in the study.
Detailed description
To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory muscle strength training exercises as compared to a prior study of expiratory muscle strength training alone is effective in improving dyspnea, respiratory symptoms, quantitative measures of pulmonary function, physical performance, and quality of life in individuals reporting persistent dyspnea post-COVID-19 at baseline, six and twelve weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, longitudinal, intervention study
| Arm | Type | Receives |
|---|---|---|
| Respiratory Muscle Strength Training | Experimental | Device: Respiratory Muscle Strength TrainersPursed Lip Breathing: Participants will perform two sets of 10 repetitions twice per day. Inspiratory Muscle Strength Training (IMST): The participant will use an IMST trainer provided by the study (Threshold Inspiratory Muscle Strength Trainer). This exercise is repeated for a 3-minute duration, followed by a rest period of 2 minutes. This cycle is repeated for 6 cycles over a 30-minute timespan. This exercise will be performed 3 times/week on alternating days. Expiratory Muscle Strength Training (EMST): The participant will use an EMST trainer (EMST 150) provided by the study. This exercise is repeated for a 3-minute duration, followed by a rest period of 2 minutes. The cycle is repeated for 6 cycles over a 30-minute timespan. This exercise will be performed 3 x/week on opposite days of the inspiratory muscle strength training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-reported history of a positive COVID-19 diagnosis in the past.
- Able to walk independently
- Cognitively intact
- English-speaking
- Dyspnea at rest or with activity rated at 3 or greater on the Dyspnea on Exertion scale.
Key exclusion criteria (2 listed)
- Individuals who are wheelchair bound or who cannot walk independently.
- Individuals hospitalized for COVID-19 who self-report that they received mechanical ventilation during hospitalization.
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 |
|---|---|---|
| Respiratory Muscle Strength TrainersAlso: Threshold Inspiratory Muscle Strength Trainer, Expiratory Muscle Strength Trainer (EMST 150)Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate. | Device | Respiratory Muscle Strength Training |
Primary outcome
Modified Medical Research Council Scale
Time frame: Baseline, 6-weeks, and 12-week measurements
Scale of 0-4 with 4 being the most severe dyspnea.
COPD Assessment Test
Time frame: Baseline, 6-weeks, and 12-week measurements.
8-item questionnaire with a semantic, 6-point differential scale for each item. Scores range from 0-40 with higher scores indicating more severe respiratory symptoms.
Forced Expiratory Volume over 1 second (FEV1)
Time frame: Baseline, 6-weeks, and 12-week measurements
Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).
Peak Inspiratory Flow
Time frame: Baseline, 6-weeks, and 12-week measurements.
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
Thoracic Expansion Measures
Time frame: Baseline, 6-weeks, and 12-week measurements
Gulick tape measure positioned around the participant's chest at the 4th intercostal space. Participant breathes in and out as far as possible and the difference between the 2 values equals thoracic expansion.
Physical Capacity
Time frame: Baseline, 6-weeks, and 12-week measurements.
6 Minute Walk Test following the American Thoracic Society Procedure: 50-meter distance is marked. Participant walks as quickly as possible for 6 minutes. Results recorded in meters. Vital signs and oxygen saturation monitored and recorded.
EuroQoL-5 Dimension-5 Level
Time frame: Baseline, 6-weeks, and 12-week measurements.
EuroQoL-5 Dimension-5 Level to evaluate 5 dimensions of quality of life including mobility, self-care, usual activities, discomfort and pain, anxiety, and depression. Each is scored using a 5-point semantic scale.
1 secondary outcome
Feasibility and Acceptability of the Intervention
Time frame: 12-weeks.
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 15 Apr 2025.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 19720809Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
- Background: PubMed 3342669Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
- Background: PubMed 37132243Morgan S, Visovsky C, Thomas B, Klein AB, Ji M, Schwab L, Coury J. Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19. Clin Nurs Res. 2023 Jun;32(5):895-901. doi: 10.1177/10547738231170496. Epub 2023 May 3.
- Background: PubMed 16942867Mota S, Guell R, Barreiro E, Solanes I, Ramirez-Sarmiento A, Orozco-Levi M, Casan P, Gea J, Sanchis J. Clinical outcomes of expiratory muscle training in severe COPD patients. Respir Med. 2007 Mar;101(3):516-24. doi: 10.1016/j.rmed.2006.06.024. Epub 2006 Aug 30.
- Derived from this study: PubMed 40995943Morgan SP, Thomas B, Rodriguez CS, Johnson A, Beckie TM. Inspiratory and Expiratory Muscle Strength Training for Persistent Dyspnea in Post-COVID-19. Clin Nurs Res. 2025 Nov;34(8):462-471. doi: 10.1177/10547738251371244. Epub 2025 Sep 25.
- Individual participant dataSharing planned: Yes. Data will be available at the end of the study to other investigators and will include the data associated with the study outcomes (Dyspnea, quality of life, pulmonary symptoms, thoracic expansion, pulmonary function tests, six minute walk test, demographics, and feasibility and acceptability).
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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.
Constance Visovsky, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Strength Trainers in people with Post-COVID-19 Syndrome and Dyspnea, run by University of South Florida 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 7 inclusion and 2 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 15 Apr 2025. 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?
Modified Medical Research Council Scale (time frame: Baseline, 6-weeks, and 12-week measurements). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06091280, which also lists 7 linked publications.
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 15 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.