Status:
RECRUITING
Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Arthropathy of Knee
Arthropathy of Hip
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 decre...
Detailed Description
Preoperative inspiratory muscle training (IMT) has been shown to reduce post operative complications (PPC's) following prolonged cardiac surgeries, but its potential benefits have not been investigate...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05381818
Start Date
July 1 2022
End Date
August 1 2026
Last Update
August 29 2025
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209