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NCT Number: NCT05381818

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Daily Inspiratory Muscle Training (dIMT)

Behavioral

Daily IMT training sessions for 2-4 weeks prior to surgery

Acute Inspiratory Muscle Training (aIMT)

Behavioral

A single session of IMT provided within 30 minutes prior to anesthesia induction.

Standard of Care (SOC)

Other

Standard of care only pre and post-operatively.

Primary outcomes

  1. Maximal Inspiratory Pressure (MIP)

    Time frame: 24-hours post-op.

    Measure of strength of inspiratory muscles.

  2. Forced vital capacity (FVC)

    Time frame: 24-hours postoperative changes

    The volume of air that can be forcefully exhaled after a full inhalation.

Secondary outcomes

  1. Post operative pulmonary complications

    Time frame: 10 days Post-op

    Incidence of post-operative pulmonary complications

Study contacts

Contact information is provided by the study sponsor or research team.

Maribel Z Ciampitti

CONTACT

[email protected]

904-891-6403

Tatiana Elias-Grajeda

CONTACT

[email protected]

(904) 244-9687

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 19, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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