Skip to main content
OpenTrials
Completed

NCT Number: NCT06091280

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Dyspnea Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory Muscle Strength Trainers

Device

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)

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Peak Inspiratory Flow

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

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

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Feasibility and Acceptability of the Intervention

    Time frame: 12-weeks.

    Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 19, 2023
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.