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

April 10, 2025 updated by: University of South Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33620
        • University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory Muscle Strength Training

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
Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.
Other Names:
  • Threshold Inspiratory Muscle Strength Trainer
  • Expiratory Muscle Strength Trainer (EMST 150)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6-weeks, and 12-week measurements
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.
Baseline, 6-weeks, and 12-week measurements.
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).
Baseline, 6-weeks, and 12-week measurements
Peak Inspiratory Flow
Time Frame: Baseline, 6-weeks, and 12-week measurements.
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
Baseline, 6-weeks, and 12-week measurements.
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.
Baseline, 6-weeks, and 12-week measurements
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.
Baseline, 6-weeks, and 12-week measurements.
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.
Baseline, 6-weeks, and 12-week measurements.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Constance Visovsky, PhD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 23, 2024

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 006272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available at the end of the study to other investigators and will include the data associated with the study outcomes (Dyspnea, quality of life, pulmonary symptoms, thoracic expansion, pulmonary function tests, six minute walk test, demographics, and feasibility and acceptability).

IPD Sharing Time Frame

Data will be available following publication of the study outcomes, and for a period of one year.

IPD Sharing Access Criteria

A formal request to the primary investigator (Dr. Constance Visovsky).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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