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Clinical Trials/NCT06091280
NCT06091280
Completed
N/A

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

University of South Florida1 site in 1 country25 target enrollmentDecember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-COVID-19 Syndrome
Sponsor
University of South Florida
Enrollment
25
Locations
1
Primary Endpoint
Modified Medical Research Council Scale
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
March 14, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Modified Medical Research Council Scale

Time Frame: Baseline, 6-weeks, and 12-week measurements

Scale of 0-4 with 4 being the most severe dyspnea.

COPD Assessment Test

Time Frame: 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

Time Frame: 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)

Time Frame: Baseline, 6-weeks, and 12-week measurements

Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).

Peak Inspiratory Flow

Time Frame: Baseline, 6-weeks, and 12-week measurements.

Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).

Thoracic Expansion Measures

Time Frame: 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

Time Frame: 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 Outcomes

  • Feasibility and Acceptability of the Intervention(12-weeks.)

Study Sites (1)

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