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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-hours post-op.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Forced vital capacity (FVC)

Maximal Inspiratory Pressure (MIP)

Secondary outcome measures

Post operative pulmonary complications

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 / 3Eligibility criteria met

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Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,634 Total Patients Enrolled

Barbara Smith, PhDPrincipal InvestigatorUniversity of Florida, College of Public Health and Health Professions - Gainesville

Stefan Braunecker, MDPrincipal InvestigatorUniversity of Florida College of Medicine-Jacksonville

2 Previous Clinical Trials

290 Total Patients Enrolled

Media Library

Acute Inspiratory Muscle Training (aIMT) Clinical Trial Eligibility Overview. Trial Name: NCT05381818 — N/A

Orthopedic Disorders Research Study Groups: Standard of Care (SOC), Acute IMT (aIMT), Daily IMT (dIMT)

Orthopedic Disorders Clinical Trial 2023: Acute Inspiratory Muscle Training (aIMT) Highlights & Side Effects. Trial Name: NCT05381818 — N/A

Acute Inspiratory Muscle Training (aIMT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05381818 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this research trial currently available?

"As per the information hosted on clinicaltrials.gov, this trial is open to candidates. The study was initially listed on July 1st 2022 and has had its most recent update October 13th of the same year."

Answered by AI

What is the aggregate count of participants in this trial?

"Yes, the details available on clinicaltrials.gov verify that this medical study is actively recruiting members. This clinical trial was initially shared on July 1st 2022 and most recently modified on October 13th 2022. The investigation requires 12 participants to be sourced from a single site for participation."

Answered by AI

Can I register for this research effort?

"This trial seeks to enroll 12 individuals with hip structure aged between 18 and 100. Crucially, candidates must possess one or more risk factors for post-operative pulmonary complications such as a history of nicotine consumption, pre-existing lung issues, shortness of breath when exerting minimal effort, reduced FEV1/FVC below the 80% mark compared to predicted values based on age and sex, past smoking related illnesses; they should also be prepared for surgeries lasting longer than 30 minutes while having the capacity to follow instructions regarding IMT exercises along with being able to communicate any adverse symptoms like fatigue or pain. Moreover, their medical record needs display"

Answered by AI

Are the criteria for this trial limited to those aged fifty and under?

"This medical research requires patients to be of legal age or older. Specifically, the enrolment criteria mandates that participants must between 18 and 100 years old. There are additional trials for minors (33) and seniors (246)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

2022. "Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05381818.