Preoperative Optimization to Improve Functional Status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Johns Hopkins University
- Locations
- 1
- Primary Endpoint
- Overall Inspiratory muscle training compliance as assessed by daily logs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Inspiratory Muscle Training (IMT) (Behavioral)
Outcomes
Primary Outcomes
Overall Inspiratory muscle training compliance as assessed by daily logs
Time Frame: 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 Outcomes
- Change in maximum inspiratory pressure(Baseline and on the 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)
- 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)
- Interest in Using Program for Future Surgeries as assessed by a likert scale(Day of Surgery, up to 10 weeks from enrollment)