Preoperative Optimization to Improve Functional Status

Study Overview
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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: 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
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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.

Official Title
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Preoperative Optimization to Improve Functional Status

Conditions
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Pulmonary Atelectasis, Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Behavioral: Inspiratory Muscle Training (IMT)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive the same intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation program<br>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)<br>* Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.<br>* Other names: IMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 10 Weeks | 
| 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. | Up to 10 Weeks | 
| 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. | 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 | 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. | Day of Surgery, up to 10 weeks from enrollment | 
| 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. | Day of Surgery, up to 10 weeks from enrollment |