Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT05381818
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Daily Inspiratory Muscle Training (dIMT) — BEHAVIORAL
    Daily IMT training sessions for 2-4 weeks prior to surgery
  • Acute Inspiratory Muscle Training (aIMT) — BEHAVIORAL
    A single session of IMT provided within 30 minutes prior to anesthesia induction.
  • Standard of Care (SOC) — OTHER
    Standard of care only pre and post-operatively.

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Maximal Inspiratory Pressure (MIP) [ Time Frame: 24-hours post-op. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaJacksonvilleFlorida32209
Maribel Ciampitti, MS
[email protected]
904-244-4690
Jennifer Bowman
[email protected]

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By research site
University of Florida· Jacksonville, FL

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