Clinical trial NCT06091280: Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
Official title: Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Dyspnea
Keywords: Respiratory muscle strength training
Respiratory symptoms
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group, longitudinal, intervention study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Modified Medical Research Council Scale
timeFrame: Baseline, 6-weeks, and 12-week measurements
measure: COPD Assessment Test
timeFrame: Baseline, 6-weeks, and 12-week measurements.
measure: Forced Expiratory Volume over 1 second (FEV1)
timeFrame: Baseline, 6-weeks, and 12-week measurements
measure: Peak Inspiratory Flow
timeFrame: Baseline, 6-weeks, and 12-week measurements.
measure: Thoracic Expansion Measures
timeFrame: Baseline, 6-weeks, and 12-week measurements
measure: Physical Capacity
timeFrame: Baseline, 6-weeks, and 12-week measurements.
measure: EuroQoL-5 Dimension-5 Level
timeFrame: Baseline, 6-weeks, and 12-week measurements.
Secondary outcomes:
measure: Feasibility and Acceptability of the Intervention
timeFrame: 12-weeks.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Constance Visovsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.