Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05381818

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
University of Florida · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALDaily Inspiratory Muscle Training (dIMT)Daily IMT training sessions for 2-4 weeks prior to surgery
BEHAVIORALAcute Inspiratory Muscle Training (aIMT)A single session of IMT provided within 30 minutes prior to anesthesia induction.
OTHERStandard of Care (SOC)Standard of care only pre and post-operatively.

Timeline

Start date
2022-07-01
Primary completion
2026-02-01
Completion
2026-08-01
First posted
2022-05-19
Last updated
2025-08-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05381818. Inclusion in this directory is not an endorsement.