Preoperative Optimization to Improve Functional Status

NCT04566172 | Withdrawn

• 1 other identifier: IRB00227450
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Atelectasis; Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Change in maximum inspiratory pressure

  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

  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

Study Arms (1)

Prehabilitation program

EXPERIMENTAL

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)

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.

Also known as: IMT

Prehabilitation program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Brown, MD

  Johns Hopkins Univesity School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the same intervention.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)