Back to resultsHome-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
Primary Purpose
Post-COVID-19 Syndrome, Dyspnea
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respiratory Muscle Strength Trainers
Sponsored by
About this trial
This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring Respiratory muscle strength training, Respiratory symptoms
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.
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Respiratory Muscle Strength Training
Arm Description
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.
Outcomes
Primary Outcome Measures
Modified Medical Research Council Scale
Scale of 0-4 with 4 being the most severe dyspnea.
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.
Forced Expiratory Volume over 1 second (FEV1)
Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).
Peak Inspiratory Flow
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
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.
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.
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.
Secondary Outcome Measures
Feasibility and Acceptability of the Intervention
Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.
Full Information
NCT ID
NCT06091280
First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT06091280
Brief Title
Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
Official Title
Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome, Dyspnea
Keywords
Respiratory muscle strength training, Respiratory symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-group, longitudinal, intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Respiratory Muscle Strength Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Respiratory Muscle Strength Trainers
Other Intervention Name(s)
Threshold Inspiratory Muscle Strength Trainer, Expiratory Muscle Strength Trainer (EMST 150)
Intervention Description
Devices provided to each participant. Resistance loading set at less than 50% of the peak inspiratory and peak expiratory flow rate.
Primary Outcome Measure Information:
Title
Modified Medical Research Council Scale
Description
Scale of 0-4 with 4 being the most severe dyspnea.
Time Frame
Baseline, 6-weeks, and 12-week measurements
Title
COPD Assessment Test
Description
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.
Time Frame
Baseline, 6-weeks, and 12-week measurements.
Title
Forced Expiratory Volume over 1 second (FEV1)
Description
Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).
Time Frame
Baseline, 6-weeks, and 12-week measurements
Title
Peak Inspiratory Flow
Description
Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).
Time Frame
Baseline, 6-weeks, and 12-week measurements.
Title
Thoracic Expansion Measures
Description
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.
Time Frame
Baseline, 6-weeks, and 12-week measurements
Title
Physical Capacity
Description
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.
Time Frame
Baseline, 6-weeks, and 12-week measurements.
Title
EuroQoL-5 Dimension-5 Level
Description
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.
Time Frame
Baseline, 6-weeks, and 12-week measurements.
Secondary Outcome Measure Information:
Title
Feasibility and Acceptability of the Intervention
Description
Recruitment and retention rates. 5-item questionnaire asking participants about the exercise protocol.
Time Frame
12-weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constance Visovsky, PhD
Phone
813-974-3831
Email
cvisovsk@usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Morgan, MS
Phone
239-898-2036
Email
morgan194@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Visovsky, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constance Visovsky, PhD
Phone
813-974-3831
Email
cvisovsk@usf.edu
First Name & Middle Initial & Last Name & Degree
Sandra Morgan, MSN
Phone
239-898-2036
Email
morgan194@usf.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
7154893
Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Results Reference
background
PubMed Identifier
12091180
Citation
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.
Results Reference
background
PubMed Identifier
19720809
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.
Results Reference
background
PubMed Identifier
3342669
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.
Results Reference
background
PubMed Identifier
37132243
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.
Results Reference
background
PubMed Identifier
16942867
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.
Results Reference
background
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Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea
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