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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Daily Inspiratory Muscle Training (dIMT) | Daily IMT training sessions for 2-4 weeks prior to surgery |
| BEHAVIORAL | 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. |
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.