Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Florida
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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),
Trial design
Design model
Parallel
Treatments tested in this trial
Daily Inspiratory Muscle Training (dIMT)
BehavioralDaily IMT training sessions for 2-4 weeks prior to surgery
Acute Inspiratory Muscle Training (aIMT)
BehavioralA single session of IMT provided within 30 minutes prior to anesthesia induction.
Standard of Care (SOC)
Other interventionStandard of care only pre and post-operatively.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Daily IMT (dIMT)Experimental treatment 1 intervention
Group B: Acute IMT (aIMT)Active comparator 1 intervention
Group C: Standard of Care (SOC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximal Inspiratory Pressure (MIP)
Measure of strength of inspiratory muscles.
Time frame
24-hours post-op.2
Forced vital capacity (FVC)
The volume of air that can be forcefully exhaled after a full inhalation.
Time frame
24-hours postoperative changesSecondary outcomes
1
Post operative pulmonary complications
Incidence of post-operative pulmonary complications
Time frame
10 days Post-opSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov