An interventional study of Daily Inspiratory Muscle Training (dIMT) and Acute Inspiratory Muscle Training (aIMT) in Arthropathy of Knee, Arthropathy of Hip and Lower Extremity Fracture, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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.
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 investigated in shorter surgeries with expected brief post-operative hospitalizations. We intend to address this unmet need by investigating preoperative IMT, an evidence-based rehab strategy to optimize lung function, prior to total joint arthroplasty surgery. The fundamental hypothesis guiding this proposal is that preoperative IMT will attenuate post-operative declines in breathing function and offset PPCs. To test this hypothesis, we will conduct a single center, randomized, prospective pilot study. Adults scheduled for total joint arthroplasty or lower extremity orthopedic surgery will be randomized to either complete daily IMT in advance of surgery (dIMT), a single acute IMT session immediately before surgery (aIMT), or usual surgical standard of care (SOC). Inspiratory muscle strength and pulmonary function will be evaluated upon enrollment \~4 weeks in advance of surgery and in pre-operative holding, and post-operative declines will be investigated through the first 24 hours (Aim 1). Further, we will investigate the effect of training assignment on post-operative clinical outcomes (Aim 2).
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Exclusion Criteria:
IMT (inspiratory muscle training) is a treatment strategy aimed to strengthen the muscles of inspiration, the diaphragm and external intercostals, by increasing their force-generating capacity. Participants in the dIMT (daily IMT) will complete daily inspiratory training exercises 2-4 weeks prior to surgery. A pressure threshold training device containing an adjustable-tension spring to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths daily at a pressure 70% of MIP and will rest 1 minute between sets. They will be asked to keep a log to track their sessions to evaluate compliance with the exercise regimen.
Behavioral: Daily Inspiratory Muscle Training (dIMT)
Patients in the aIMT (acute IMT) experimental group will complete a single session of IMT guided by a physical therapist within 30 minutes of anesthesia induction in addition to standard of care. The adjustable pressure threshold training device to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest 1 minute between sets. The training intensity will be set at 70% of MIP.
Behavioral: Acute Inspiratory Muscle Training (aIMT)
The SOC group will receive the usual surgical standard of care only.
Other: Standard of Care (SOC)
Daily IMT training sessions for 2-4 weeks prior to surgery
A single session of IMT provided within 30 minutes prior to anesthesia induction.
Standard of care only pre and post-operatively.
Maximal Inspiratory Pressure (MIP)
Measure of strength of inspiratory muscles.
Time frame: 24-hours post-op.
Forced vital capacity (FVC)
The volume of air that can be forcefully exhaled after a full inhalation.
Time frame: 24-hours postoperative changes
Post operative pulmonary complications
Incidence of post-operative pulmonary complications
Time frame: 10 days Post-op
Plan to share: No
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