NCT05381818 Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
| NCT ID | NCT05381818 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Arthropathy of Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2022-07-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Barbara Smith, PhD
PRINCIPAL INVESTIGATOR
University of Florida, College of Public Health and Health Professions - Gainesville
Frequently Asked Questions
Who can join the NCT05381818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Arthropathy of Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05381818 currently recruiting?
Yes, NCT05381818 is actively recruiting participants. Contact the research team at maribel.ciampitti@jax.ufl.edu for enrollment information.
Where is the NCT05381818 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT05381818 clinical trial?
NCT05381818 is sponsored by University of Florida. The principal investigator is Barbara Smith, PhD at University of Florida, College of Public Health and Health Professions - Gainesville. The trial plans to enroll 36 participants.