RECRUITING

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Conditions

Arthropathy of Knee Arthropathy of Hip Lower Extremity Fracture Orthopedic Disorder Inspiratory muscle training Pulmonary complications Total joint replacement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery

Quick Facts

Study Start:2022-07-01

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05381818

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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).

Inclusion Criteria

Exclusion 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

* 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).

Contacts and Locations

Study Contact

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

Principal Investigator

Stefan Braunecker, MD

PRINCIPAL_INVESTIGATOR

University of Florida College of Medicine-Jacksonville

Barbara Smith, PhD

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

University of Florida

Jacksonville, Florida, 32209

United States

Collaborators and Investigators

Sponsor: University of Florida

Stefan Braunecker, MD, PRINCIPAL_INVESTIGATOR, University of Florida College of Medicine-Jacksonville
Barbara Smith, PhD, PRINCIPAL_INVESTIGATOR, University of Florida, College of Public Health and Health Professions - Gainesville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01

Study Completion Date2025-08

Study Record Updates

Study Start Date2022-07-01

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

Inspiratory muscle training
Pulmonary complications
Total joint replacement

Additional Relevant MeSH Terms

Arthropathy of Knee
Arthropathy of Hip
Lower Extremity Fracture
Orthopedic Disorder