Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea

Conditions
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Post-COVID-19 Syndrome, Dyspnea

Intervention / Treatment
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* Device: Respiratory Muscle Strength Trainers


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-group, longitudinal, intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory Muscle Strength Training<br>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<br>* Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.<br>* Other names: Expiratory Muscle Strength Trainer (EMST 150);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medical Research Council Scale | Scale of 0-4 with 4 being the most severe dyspnea. | 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. | 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). | Baseline, 6-weeks, and 12-week measurements | 
| Peak Inspiratory Flow | Using the In-Check Peak Inspiratory Flow meter (Granbury, TX). | 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. | 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. | 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. | Baseline, 6-weeks, and 12-week measurements. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Acceptability of the Intervention | Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol. | 12-weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory muscle strength training, Respiratory symptoms