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Unable to begin the study due to COVID-19 restrictions. Once restrictions were lifted, funding was no longer available.
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Behavioral | Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Brown, MD | Johns Hopkins Univesity School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
Individual participant data will not be available to other researchers.
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
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All participants will receive the same intervention.
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|
| 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 |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |