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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single-group, longitudinal, intervention study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.
    Other names:
    • Threshold Inspiratory Muscle Strength Trainer
    • Expiratory Muscle Strength Trainer (EMST 150)

Recruiting Locations

More Details

NCT ID
NCT06091280
Status
Not yet recruiting
Sponsor
University of South Florida

Study Contact

Constance Visovsky, PhD
813-974-3831
cvisovsk@usf.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.