An interventional study of Respiratory Muscle Strength Trainers in Post-COVID-19 Syndrome and Dyspnea, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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.
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 25 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Respiratory Muscle Strength Trainers
Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.
Also known as: Threshold Inspiratory Muscle Strength Trainer, Expiratory Muscle Strength Trainer (EMST 150)
Modified Medical Research Council Scale
Scale of 0-4 with 4 being the most severe dyspnea.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 6-weeks, and 12-week measurements
Peak Inspiratory Flow
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6-weeks, and 12-week measurements.
Feasibility and Acceptability of the Intervention
Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.
Time frame: 12-weeks.
Plan to share: 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).
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of South Florida