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Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Primary Purpose

Arthropathy of Knee, Arthropathy of Hip, Lower Extremity Fracture

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Daily Inspiratory Muscle Training (dIMT)

Acute Inspiratory Muscle Training (aIMT)

Standard of Care (SOC)

About this trial

This is an interventional prevention trial for Arthropathy of Knee focused on measuring Inspiratory muscle training, Pulmonary complications, Total joint replacement

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Daily IMT (dIMT)

Acute IMT (aIMT)

Standard of Care (SOC)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Maximal Inspiratory Pressure (MIP)

Measure of strength of inspiratory muscles.

Forced vital capacity (FVC)

The volume of air that can be forcefully exhaled after a full inhalation.

Secondary Outcome Measures

Post operative pulmonary complications

Incidence of post-operative pulmonary complications

Full Information

NCT ID

NCT05381818

First Posted

May 16, 2022

Last Updated

October 20, 2023

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT05381818

Brief Title

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

Official Title

Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Preoperative inspiratory muscle training (IMT) has been shown to reduce post operative complications (PPC's) following prolonged cardiac surgeries, but its potential benefits have not been investigated in shorter surgeries with expected brief post-operative hospitalizations. We intend to address this unmet need by investigating preoperative IMT, an evidence-based rehab strategy to optimize lung function, prior to total joint arthroplasty surgery. The fundamental hypothesis guiding this proposal is that preoperative IMT will attenuate post-operative declines in breathing function and offset PPCs. To test this hypothesis, we will conduct a single center, randomized, prospective pilot study. Adults scheduled for total joint arthroplasty or lower extremity orthopedic surgery will be randomized to either complete daily IMT in advance of surgery (dIMT), a single acute IMT session immediately before surgery (aIMT), or usual surgical standard of care (SOC). Inspiratory muscle strength and pulmonary function will be evaluated upon enrollment ~4 weeks in advance of surgery and in pre-operative holding, and post-operative declines will be investigated through the first 24 hours (Aim 1). Further, we will investigate the effect of training assignment on post-operative clinical outcomes (Aim 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Inspiratory muscle training, Pulmonary complications, Total joint replacement

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Daily IMT (dIMT)

Arm Type

Experimental

Arm Description

Arm Title

Acute IMT (aIMT)

Arm Type

Active Comparator

Arm Description

Arm Title

Standard of Care (SOC)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Daily Inspiratory Muscle Training (dIMT)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Acute Inspiratory Muscle Training (aIMT)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard of Care (SOC)

Intervention Description

Standard of care only pre and post-operatively.

Primary Outcome Measure Information:

Title

Maximal Inspiratory Pressure (MIP)

Description

Measure of strength of inspiratory muscles.

Time Frame

24-hours post-op.

Title

Forced vital capacity (FVC)

Description

The volume of air that can be forcefully exhaled after a full inhalation.

Time Frame

24-hours postoperative changes

Secondary Outcome Measure Information:

Title

Post operative pulmonary complications

Description

Incidence of post-operative pulmonary complications

Time Frame

10 days Post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maribel Z Ciampitti

Phone

904-891-6403

maribel.ciampitti@jax.ufl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jenny Jimenez

Phone

(904) 244-8269

Marie.Jimenez@jax.ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Braunecker, MD

Organizational Affiliation

University of Florida College of Medicine-Jacksonville

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Barbara Smith, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maribel Ciampitti, MS

Phone

904-244-4690

maribel.ciampitti@jax.ufl.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Bowman

Jennifer.Bowman@jax.ufl.edu

12. IPD Sharing Statement

Plan to Share IPD

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Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

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