Preoperative Optimization to Improve Functional Status

NCT ID: NCT04566172

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-03-01

Brief Summary

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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

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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.

Conditions

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Pulmonary Atelectasis Pneumonia, Ventilator-Associated

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive the same intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type BEHAVIORAL

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

Interventions

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Inspiratory Muscle Training (IMT)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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IMT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Univesity School of Medicine

Locations

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The Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00227450

Identifier Type: -

Identifier Source: org_study_id

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