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Inspiratory Muscle Training for Orthopedic Surgery Recovery

N/A

Recruiting

Led By Barbara Smith, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of smoking-related lung disease

Age 18 or older

Must not have

Preoperative dependence on continuous supplemental oxygen

Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1<50% predicted)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-hours post-op.

Awards & highlights

No Placebo-Only Group

Summary

This trialwill evaluate if pre-surgery breathing exercises can help improve breathing function and recovery after orthopedic surgery. #medicalresearch

Who is the study for?

This trial is for adults over 18 who have smoked or currently smoke, may have lung disease, and are undergoing orthopedic surgery. They should be able to do breathing exercises and report any issues like pain. People with severe lung obstruction, very poor health status, recent serious infections, oxygen dependency, certain neurological conditions or those in pulmonary rehab can't join.

What is being tested?

The study tests if pre-surgery breathing exercises (acute or daily) can improve recovery compared to standard care in patients having joint surgery. It aims to see whether these exercises before surgery help strengthen the respiratory muscles and enhance postoperative breathing function.

What are the potential side effects?

Potential side effects from inspiratory muscle training could include discomfort or fatigue during the exercises. However, specific side effects will depend on individual tolerance and condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lung problems due to smoking.

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I am 18 years old or older.

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My surgery is expected to last more than 30 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need to use extra oxygen all the time.

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I have severe lung disease with less than half the normal airflow.

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My health is severely limited by my illness.

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I do not have an infectious disease that requires isolation.

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I need a breathing machine during the day (nighttime CPAP is okay).

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I have been diagnosed with a neurological condition like MS, ALS, Parkinson's, or have had a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-hours post-op.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-hours post-op.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hours post-op. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Forced vital capacity (FVC)

Maximal Inspiratory Pressure (MIP)

Secondary study objectives

Post operative pulmonary complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Daily IMT (dIMT)Experimental Treatment1 Intervention

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.

Group II: Standard of Care (SOC)Active Control1 Intervention

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

Group III: Acute IMT (aIMT)Active Control1 Intervention

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.

0 / 9Eligibility criteria met