Preoperative Optimization to Improve Functional Status

Not Applicable

Withdrawn

• Conditions: Pulmonary Atelectasis; Pneumonia, Ventilator-Associated
• Interventions: Behavioral: Inspiratory Muscle Training (IMT)

• Registration Number: NCT04566172
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Study Start: 2024-11-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation program	Inspiratory Muscle Training (IMT)	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.

Primary Outcome Measures

Name	Time	Method
Overall Inspiratory muscle training compliance as assessed by daily logs	Up to 10 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in maximum inspiratory pressure	Baseline and on the day of surgery, up to 10 weeks from enrollment	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.
Overall Satisfaction with the Program as assessed by a likert scale	Day of Surgery, up to 10 weeks from enrollment	The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction.
Number of attempted inspiratory muscle training as assessed by percent days the program was attempted	Up to 10 Weeks	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.
Number of completed inspiratory muscle training as assessed by percent days with full compliance	Up to 10 Weeks	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.
Interest in Using Program for Future Surgeries as assessed by a likert scale	Day of Surgery, up to 10 weeks from enrollment	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.

Trial Locations

Locations (1)

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States