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

NCT ID: NCT06091280

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-03-14

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.

Conditions

Post-COVID-19 Syndrome; Dyspnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Respiratory Muscle Strength Trainers

Intervention Type: DEVICE

Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Threshold Inspiratory Muscle Strength Trainer; Expiratory Muscle Strength Trainer (EMST 150)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constance Visovsky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 7154893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12091180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19720809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3342669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37132243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16942867 (View on PubMed)

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 Sep 25:10547738251371244. doi: 10.1177/10547738251371244. Online ahead of print.

Reference Type: DERIVED

PMID: 40995943 (View on PubMed)

Other Identifiers

006272

Identifier Type: -

Identifier Source: org_study_id