Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

NCT05381818 | Recruiting

• 2 other identifiers: IRB202102681R21AG083667
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee; Arthropathy of Hip; Lower Extremity Fracture; Orthopedic Disorder

Keywords

Inspiratory muscle training; Pulmonary complications; Total joint replacement

Outcome Measures

Primary Outcomes (2)

• Maximal Inspiratory Pressure (MIP)

  Measure of strength of inspiratory muscles.

  24-hours post-op.

• Forced vital capacity (FVC)

  The volume of air that can be forcefully exhaled after a full inhalation.

  24-hours postoperative changes

Secondary Outcomes (1)

• Post operative pulmonary complications

  10 days Post-op

Study Arms (3)

Daily IMT (dIMT)

EXPERIMENTAL

IMT (inspiratory muscle training) is a treatment strategy aimed to strengthen the muscles of inspiration, the diaphragm and external intercostals, by increasing their force-generating capacity. Participants in the dIMT (daily IMT) will complete daily inspiratory training exercises 2-4 weeks prior to surgery. A pressure threshold training device containing an adjustable-tension spring to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths daily at a pressure 70% of MIP and will rest 1 minute between sets. They will be asked to keep a log to track their sessions to evaluate compliance with the exercise regimen.

Behavioral: Daily Inspiratory Muscle Training (dIMT)

Acute IMT (aIMT)

ACTIVE COMPARATOR

Patients in the aIMT (acute IMT) experimental group will complete a single session of IMT guided by a physical therapist within 30 minutes of anesthesia induction in addition to standard of care. The adjustable pressure threshold training device to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest 1 minute between sets. The training intensity will be set at 70% of MIP.

Behavioral: Acute Inspiratory Muscle Training (aIMT)

Standard of Care (SOC)

ACTIVE COMPARATOR

The SOC group will receive the usual surgical standard of care only.

Other: Standard of Care (SOC)

Interventions

Daily Inspiratory Muscle Training (dIMT) BEHAVIORAL

Daily IMT training sessions for 2-4 weeks prior to surgery

Daily IMT (dIMT)

Acute Inspiratory Muscle Training (aIMT) BEHAVIORAL

A single session of IMT provided within 30 minutes prior to anesthesia induction.

Acute IMT (aIMT)

Standard of Care (SOC) OTHER

Standard of care only pre and post-operatively.

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Barbara Smith, PhD

  University of Florida, College of Public Health and Health Professions - Gainesville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maribel Z Ciampitti

CONTACT

904-891-6403; maribel.ciampitti@jax.ufl.edu

Tatiana Elias-Grajeda

CONTACT

(904) 244-9687; Tatiana.Elias-Grajeda@jax.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: July 1, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)