Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
- Conditions
- DyspneaPost-COVID-19 Syndrome
- Registration Number
- NCT06091280
- Lead Sponsor
- University of South Florida
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method Feasibility and Acceptability of the Intervention 12-weeks. Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.
Trial Locations
- Locations (1)
University of South Florida
🇺🇸Tampa, Florida, United States
University of South Florida🇺🇸Tampa, Florida, United States