Preoperative Optimization to Improve Functional Status

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04566172
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 34.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Atelectasis; Pneumonia, Ventilator-Associated	Behavioral: Inspiratory Muscle Training (IMT)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will receive the same intervention.All participants will receive the same intervention.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Preoperative Optimization to Improve Functional Status
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Inspiratory Muscle Training (IMT); Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.; Other Names: IMT

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Charles Brown, MD, Johns Hopkins Univesity School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04566172
• Other Study ID Numbers: IRB00227450
• First Posted: Sep 28, 2020
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia, Ventilator-Associated; Pulmonary Atelectasis

Study Results

No Results Posted as of Mar 10, 2022