Preoperative Optimization to Improve Functional Status

Johns Hopkins University

Overview

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

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

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Pulmonary Atelectasis Pneumonia, Ventilator-Associated

Interventions

Inspiratory Muscle Training (IMT)BEHAVIORAL

Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 10 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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