Actively Recruiting
Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery
Led by University of Florida · Updated on 2026-05-15
36
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of respiratory strengthening exercises on breathing function in adults undergoing total joint arthroplasty or lower extremity orthopedic surgery. The study aims to determine if exercising the breathing muscles before surgery can strengthen them and improve recovery, as breathing function typically decreases for a few days after surgery. This is a randomized, prospective pilot study focused on reducing post-operative pulmonary complications in shorter surgeries with expected brief hospital stays. Participants will be randomly assigned to one of three groups: daily inspiratory muscle training (dIMT) for 2-4 weeks prior to surgery, a single acute inspiratory muscle training session (aIMT) immediately before surgery, or usual surgical standard of care (SOC). The training uses a pressure threshold device that provides resistance during inspiration. The dIMT group completes daily sessions of 5 sets of 5 maximal breaths at 70% of maximal inspiratory pressure (MIP), while the aIMT group completes one similar session guided by a physical therapist within 30 minutes before anesthesia. The SOC group receives standard care without training. Participants will be evaluated about 4 weeks before surgery, in pre-operative holding, and during the first 24 hours post-surgery. Measurements include inspiratory muscle strength and lung function tests such as maximal inspiratory pressure and forced vital capacity. Researchers will also monitor post-operative pulmonary complications up to 10 days after surgery. Participants will keep logs to track exercise compliance, and the study will assess the impact of training on breathing function decline and clinical outcomes following surgery.
CONDITIONS
Brief Title
Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- History of current or previous tobacco use, including vaping with nicotine
- Presence of one or more risk factors for post-operative pulmonary complications such as diagnosed lung disease, shortness of breath with minimal exertion, reduced FEV1 or FVC below 80% of predicted, or respiratory muscle weakness
- History of smoking-related lung disease
- Planned surgery time longer than 30 minutes
- Ability to follow instructions to perform inspiratory muscle training exercises
- Ability to communicate adverse effects like pain or fatigue or need for help
You will not qualify if you...
- American Society of Anesthesiologists physical status classification of 4 or higher
- Recent acute pneumonia or lower respiratory infection within 2 weeks requiring corticosteroids or antibiotics
- Dependence on continuous supplemental oxygen before surgery
- Dependence on positive pressure breathing support while awake and upright (nighttime CPAP allowed)
- Diagnosis of neurologic conditions such as MS, ALS, Parkinson's disease, or stroke
- Currently participating in a pulmonary rehabilitation program
- Severe obstructive pulmonary disease classified as GOLD 3 or higher with FEV1 less than 50% predicted
- Infectious disease requiring isolation, such as COVID-19
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks prior to surgery or single session immediately before surgery
Participants randomized to daily inspiratory muscle training complete daily training exercises for 2 to 4 weeks prior to surgery. Those in the acute group complete a single session immediately before surgery, while others receive standard care.
Daily training sessions for 2 to 4 weeks for daily IMT group; 1 session immediately before surgery for acute IMT group
Duration - Hospitalization period including first 24 hours post-surgery
Participants undergo total joint arthroplasty surgery followed by monitoring of breathing function and pulmonary outcomes in the first 24 hours after surgery.
1 hospital stay including assessments pre- and post-operation
Duration - 10 days post-surgery
Participants are monitored for post-operative pulmonary complications up to 10 days after surgery.
Follow-up visits or assessments over 10 days post-operation
Trial Site Locations
Total: 1 location
1
University of Florida
Jacksonville, Florida, United States, 32209
Actively Recruiting
Research Team
M
Maribel Z Ciampitti
T
Tatiana Elias-Grajeda
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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