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

Not Applicable

Recruiting

• Conditions: Dyspnea; Post-COVID-19 Syndrome
• Interventions: Device: Respiratory Muscle Strength Trainers

• 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.

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-19
• Study Start: 2023-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory Muscle Strength Training	Respiratory Muscle Strength Trainers	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.

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