Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Last updated: July 11, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Musculoskeletal Diseases

Treatment

Standard of Care (SOC)

Acute Inspiratory Muscle Training (aIMT)

Daily Inspiratory Muscle Training (dIMT)

Clinical Study ID

NCT05381818
IRB202102681
R21AG083667
  • Ages 18-100
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 or older

  • History of current or previous tobacco use (including vaping containing nicotineproducts)

  • One or more risk factors for post operative pulmonary complications includinghistory of current or previous tobacco use, a clinically diagnosed lung disease,shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predictedor 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 forassistance

Exclusion

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 twoweeks requiring acute corticosteroid or antibiotic medication,

  • Preoperative dependence on continuous supplemental oxygen dependence.

  • Preoperative dependence on positive pressure breathing support while awake andupright (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 forChronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1<50% predicted.

  • Patients with an infectious disease requiring isolation (i.e. COVID-19).

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: Standard of Care (SOC)
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
August 31, 2026

Study 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 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).

Connect with a study center

  • University of Florida

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

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