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

NCT06091280 | Completed FDA Device

• 1 other identifier: 006272
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Syndrome; Dyspnea

Keywords

Respiratory muscle strength training; Respiratory symptoms

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Feasibility and Acceptability of the Intervention

  12-weeks.

Study Arms (1)

Respiratory Muscle Strength Training

EXPERIMENTAL

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

Interventions

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.

Also known as: Threshold Inspiratory Muscle Strength Trainer, Expiratory Muscle Strength Trainer (EMST 150)

Respiratory Muscle Strength Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

Related Publications (7)

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

  PMID: 19720809 BACKGROUND

• Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.

  PMID: 3342669 BACKGROUND

• Morgan S, Visovsky C, Thomas B, Klein AB, Ji M, Schwab L, Coury J. Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19. Clin Nurs Res. 2023 Jun;32(5):895-901. doi: 10.1177/10547738231170496. Epub 2023 May 3.

  PMID: 37132243 BACKGROUND

• Mota S, Guell R, Barreiro E, Solanes I, Ramirez-Sarmiento A, Orozco-Levi M, Casan P, Gea J, Sanchis J. Clinical outcomes of expiratory muscle training in severe COPD patients. Respir Med. 2007 Mar;101(3):516-24. doi: 10.1016/j.rmed.2006.06.024. Epub 2006 Aug 30.

  PMID: 16942867 BACKGROUND

• Morgan SP, Thomas B, Rodriguez CS, Johnson A, Beckie TM. Inspiratory and Expiratory Muscle Strength Training for Persistent Dyspnea in Post-COVID-19. Clin Nurs Res. 2025 Nov;34(8):462-471. doi: 10.1177/10547738251371244. Epub 2025 Sep 25.

  PMID: 40995943 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Dyspnea; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

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

Study Officials

• Constance Visovsky, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group, longitudinal, intervention study

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 19, 2023
• Study Start: December 1, 2023
• Primary Completion: December 23, 2024
• Study Completion: March 14, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available following publication of the study outcomes, and for a period of one year.
• Access Criteria: A formal request to the primary investigator (Dr. Constance Visovsky).

Locations

US (1)