Orthopedic Disorder Clinical Trial
Official title:
Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery
NCT number | NCT05381818 |
Other study ID # | IRB202102681 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | August 2025 |
The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | August 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 18 or older - History of current or previous tobacco use (including vaping containing nicotine products) - One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex. - History of smoking related lung disease - Projected surgical time > 30 minutes - Ability to follow instructions to complete IMT exercises - Ability to communicate adverse effects such as pain or fatigue or the need for assistance Exclusion Criteria: - American Society of Anesthesiologists physical status classification of 4 or greater . - Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication, - Preoperative dependence on continuous supplemental oxygen dependence. - Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted), - Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke), - Participating in a pulmonary rehabilitation program - Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1<50% predicted. - Patients with an infectious disease requiring isolation (i.e. COVID-19). |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal Inspiratory Pressure (MIP) | Measure of strength of inspiratory muscles. | 24-hours post-op. | |
Primary | Forced vital capacity (FVC) | The volume of air that can be forcefully exhaled after a full inhalation. | 24-hours postoperative changes | |
Secondary | Post operative pulmonary complications | Incidence of post-operative pulmonary complications | 10 days Post-op |
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