Dyspnea, Post-COVID-19 Syndrome
Conditions
Keywords
Respiratory muscle strength training, Respiratory symptoms
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.
Interventions
DEVICERespiratory Muscle Strength Trainers
Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-group, longitudinal, intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability of the Intervention | 12-weeks. | Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol. |
Countries
United States
Outcome results
None listed