Recruiting

Inspiratory Muscle Strength Training

Sponsor:

University of Florida

Code:

NCT05381818

Conditions

Arthropathy of Knee

Arthropathy of Hip

Lower Extremity Fracture

Orthopedic Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Daily Inspiratory Muscle Training (dIMT)

Acute Inspiratory Muscle Training (aIMT)

Standard of Care (SOC)

Study Details

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

Study ID

NCT05381818

Start date

Jul 1, 2022

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Daily IMT (dIMT)

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.

active comparator: Acute IMT (aIMT)

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.

active comparator: Standard of Care (SOC)

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

Interventions

Daily Inspiratory Muscle Training (dIMT)

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

Acute Inspiratory Muscle Training (aIMT)

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

Standard of Care (SOC)

Standard of care only pre and post-operatively.

Primary outcome measure

  • Maximal Inspiratory Pressure (MIP) [ Time Frame: 24-hours post-op. ]
  • Forced vital capacity (FVC) [ Time Frame: 24-hours postoperative changes ]

Central Contacts and Locations

Central contacts

Maribel Z Ciampitti

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

Tatiana Elias-Grajeda

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

Locations

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Maribel Ciampitti, MS

904-244-4690maribel.ciampitti@jax.ufl.edu

Jennifer Bowman

Jennifer.Bowman@jax.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

May 15, 2026

Last verified

Aug, 2025

Keywords

  • Inspiratory muscle training
  • Pulmonary complications
  • Total joint replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-15.