Preoperative Optimization to Improve Functional Status
Primary Purpose
Pulmonary Atelectasis, Pneumonia, Ventilator-Associated
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Muscle Training (IMT)
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Atelectasis
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
Sites / Locations
- The Johns Hopkins University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prehabilitation program
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of attempted inspiratory muscle training as assessed by percent days the program was attempted
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
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.
Change in maximum inspiratory pressure
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.
Interest in Using Program for Future Surgeries as assessed by a likert scale
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.
Overall Satisfaction with the Program as assessed by a likert scale
The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction.
Full Information
NCT ID
NCT04566172
First Posted
September 22, 2020
Last Updated
October 6, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04566172
Brief Title
Preoperative Optimization to Improve Functional Status
Official Title
Preoperative Optimization to Improve Functional Status
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
To obtain information on feasibility and utilization of the program
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Pneumonia, Ventilator-Associated
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the same intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory Muscle Training (IMT)
Other Intervention Name(s)
IMT
Intervention Description
Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.
Primary Outcome Measure Information:
Title
Overall Inspiratory muscle training compliance as assessed by daily logs
Description
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.
Time Frame
Up to 10 Weeks
Secondary Outcome Measure Information:
Title
Number of attempted inspiratory muscle training as assessed by percent days the program was attempted
Description
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.
Time Frame
Up to 10 Weeks
Title
Number of completed inspiratory muscle training as assessed by percent days with full compliance
Description
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.
Time Frame
Up to 10 Weeks
Title
Change in maximum inspiratory pressure
Description
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.
Time Frame
Baseline and on the day of surgery, up to 10 weeks from enrollment
Title
Interest in Using Program for Future Surgeries as assessed by a likert scale
Description
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.
Time Frame
Day of Surgery, up to 10 weeks from enrollment
Title
Overall Satisfaction with the Program as assessed by a likert scale
Description
The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction.
Time Frame
Day of Surgery, up to 10 weeks from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirinda J Anderson White, RN
Phone
410-955-6488
Email
mander47@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
Organizational Affiliation
Johns Hopkins Univesity School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.
Learn more about this trial
Preoperative Optimization to Improve Functional Status
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