Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Respiratory Muscle Strength Training 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Modified Medical Research Council Scale [Baseline, 6-weeks, and 12-week measurements]
Scale of 0-4 with 4 being the most severe dyspnea.
- COPD Assessment Test [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) [Baseline, 6-weeks, and 12-week measurements]
Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).
- Peak Inspiratory Flow [Baseline, 6-weeks, and 12-week measurements.]
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
- Thoracic Expansion Measures [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 [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 [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.
Secondary Outcome Measures
- Feasibility and Acceptability of the Intervention [12-weeks.]
Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Self-reported history of a positive COVID-19 diagnosis in the past.
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Able to walk independently
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Cognitively intact
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English-speaking
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Dyspnea at rest or with activity rated at 3 or greater on the Dyspnea on Exertion scale.
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May use oxygen.
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May be taking medications.
Exclusion Criteria:
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Individuals who are wheelchair bound or who cannot walk independently.
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Individuals hospitalized for COVID-19 who self-report that they received mechanical ventilation during hospitalization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Florida | Tampa | Florida | United States | 33620 |
Sponsors and Collaborators
- University of South Florida
Investigators
- Principal Investigator: Constance Visovsky, PhD, University of South Florida
Study Documents (Full-Text)
None provided.More Information
Publications
- ATS 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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Jones 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.
- Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
- Morgan 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.
- Mota 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.
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