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Clinical Trials/NCT04566172
NCT04566172
Withdrawn
N/A

Preoperative Optimization to Improve Functional Status

Johns Hopkins University1 site in 1 countryNovember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Atelectasis
Sponsor
Johns Hopkins University
Locations
1
Primary Endpoint
Overall Inspiratory muscle training compliance as assessed by daily logs
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
March 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Overall Inspiratory muscle training compliance as assessed by daily logs

Time Frame: 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 Outcomes

  • Change in maximum inspiratory pressure(Baseline and on the day of surgery, up to 10 weeks from enrollment)
  • Overall Satisfaction with the Program as assessed by a likert scale(Day of Surgery, up to 10 weeks from enrollment)
  • Number of attempted inspiratory muscle training as assessed by percent days the program was attempted(Up to 10 Weeks)
  • Number of completed inspiratory muscle training as assessed by percent days with full compliance(Up to 10 Weeks)
  • Interest in Using Program for Future Surgeries as assessed by a likert scale(Day of Surgery, up to 10 weeks from enrollment)

Study Sites (1)

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