Preoperative Optimization to Improve Functional Status

This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients.

The two specific aims of this study are to conduct an initial pilot study with the following goals:

1. To obtain information on feasibility and utilization of the program
2. To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Atelectasis; Pneumonia, Ventilator-Associated
• Intervention / Treatment: Behavioral: Inspiratory Muscle Training (IMT)

Detailed Description

Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mirinda J Anderson White, RN; Phone Number: 410-955-6488; Email: mander47@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment
• Age>65 y/o

Exclusion Criteria:

• Impaired cognition that would limit participation in the program
• History of spontaneous pneumothorax
• Any other physician judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation program; Patient undergoing thoracic or upper abdominal surgery as part of their regular medical care will be approached. Participants will receive a prehabilitation program that includes an inspiratory muscle training that they will do leading up to the day of their surgery.	Behavioral: Inspiratory Muscle Training (IMT); Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.; Other Names: IMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Inspiratory muscle training compliance as assessed by daily logs	The primary outcome variable will be compliance with >70% of inspiratory muscle training. Patients will be instructed to follow the prescribed program daily from the day consent is obtained until the day of surgery. Patients will complete a daily log of breathing exercises.	Up to 10 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempted inspiratory muscle training as assessed by percent days the program was attempted	Secondary feasibility outcome variables will be compliance (percent days the program was attempted). Patients will complete a daily log of breathing exercises and document the completion of each breathing exercise. The amount of days to be measured will be the number of days from consent to the day of surgery.	Up to 10 Weeks
Number of completed inspiratory muscle training as assessed by percent days with full compliance	Secondary feasibility outcome variables will be compliance (percent days with full compliance). Patients will complete a daily log of breathing exercises and document the completion of each breathing exercise. The amount of days to be measured will be the number of days from consent to the day of surgery.	Up to 10 Weeks
Change in maximum inspiratory pressure	The change in maximum inspiratory pressure will be determined by comparing the baseline maximum inspiratory pressure to the maximum inspiratory pressure on the day of surgery to assess the efficacy of the inspiratory muscle training.	Baseline and on the day of surgery, up to 10 weeks from enrollment
Interest in Using Program for Future Surgeries as assessed by a likert scale	The patient's willingness to use this program for future surgeries will be measured using the Likert scale 1 to 5. Higher scores mean more willingness to use program for future surgeries.	Day of Surgery, up to 10 weeks from enrollment
Overall Satisfaction with the Program as assessed by a likert scale	The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction.	Day of Surgery, up to 10 weeks from enrollment

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Charles Brown, MD, Johns Hopkins Univesity School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pulmonary Atelectasis; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: IRB00227450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No