Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Orthopedic Disorder Clinical Trial

Official title:

Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381818
• Other study ID #: IRB202102681
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: University of Florida
• Contact: Maribel Z Ciampitti
• Phone: 904-891-6403
• Email: maribel.ciampitti[@]jax.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases
• Lower Extremity Fracture
• Musculoskeletal Diseases
• Orthopedic Disorder
• Respiratory Aspiration

Intervention

Behavioral:
• Daily Inspiratory Muscle Training (dIMT)
Daily IMT training sessions for 2-4 weeks prior to surgery
• Acute Inspiratory Muscle Training (aIMT)
A single session of IMT provided within 30 minutes prior to anesthesia induction.

Other:
• Standard of Care (SOC)
Standard of care only pre and post-operatively.

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Inspiratory Pressure (MIP)	Measure of strength of inspiratory muscles.	24-hours post-op.
Primary	Forced vital capacity (FVC)	The volume of air that can be forcefully exhaled after a full inhalation.	24-hours postoperative changes
Secondary	Post operative pulmonary complications	Incidence of post-operative pulmonary complications	10 days Post-op