Breathing exercises before joint surgery
Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery
NA · University of Florida · NCT05381818
This study is testing if breathing exercises before joint surgery can help patients breathe better after their operation and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05381818 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of preoperative inspiratory muscle training (IMT) on breathing function in patients undergoing total joint arthroplasty or lower extremity orthopedic surgery. Participants will be randomized into three groups: those completing daily IMT, those receiving a single acute IMT session before surgery, and those receiving standard surgical care. The study aims to determine if preoperative IMT can reduce post-operative declines in breathing function and minimize pulmonary complications. Assessments will be made before surgery and during the first 24 hours post-operation to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a history of tobacco use or risk factors for post-operative pulmonary complications.
Not a fit: Patients with severe pre-existing respiratory conditions or those requiring continuous supplemental oxygen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce complications related to breathing after orthopedic surgery.
How similar studies have performed: Previous studies have shown that inspiratory muscle training can reduce complications in cardiac surgeries, suggesting potential benefits in orthopedic settings, though this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Jacksonville, Florida
- University of Florida — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Barbara Smith, PhD — University of Florida, College of Public Health and Health Professions - Gainesville
- Study coordinator: Maribel Z Ciampitti
- Email: maribel.ciampitti@jax.ufl.edu
- Phone: 904-891-6403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthropathy of Knee, Arthropathy of Hip, Lower Extremity Fracture, Orthopedic Disorder, Inspiratory muscle training, Pulmonary complications, Total joint replacement