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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091280
• Other study ID #: 006272
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: University of South Florida
• Contact: Constance Visovsky, PhD
• Phone: 813-974-3831
• Email: cvisovsk[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Dyspnea
• Post-COVID-19 Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Medical Research Council Scale	Scale of 0-4 with 4 being the most severe dyspnea.	Baseline, 6-weeks, and 12-week measurements
Primary	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.
Primary	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
Primary	Peak Inspiratory Flow	Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).	Baseline, 6-weeks, and 12-week measurements.
Primary	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
Primary	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.
Primary	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	Feasibility and Acceptability of the Intervention	Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.	12-weeks.