Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02843750|
Recruitment Status : Withdrawn (Difficulty recruiting patients)
First Posted : July 26, 2016
Last Update Posted : December 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Esophagus Cancer of the Esophagus Esophageal Cancer Esophagus Cancer Esophagus Neoplasm Neoplasms, Esophageal||Behavioral: Inspiratory Muscle Training-Rehabilitation Other: Questionnaires||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Inspiratory Muscle Training-Rehabilitation
Patients will start the IMT-R, following their consent and within 2 weeks of their scheduled surgery: 10 sessions lasting about 90 minutes. Participants who completed their initial IMT greater than 2 weeks prior to surgery will have an additional visit prior to surgery. Participants will receive a Participant Manual demonstrating and explaining the rehabilitation process. Participants will also receive a log for recording their efforts and notes. A DVD of the rehabilitation is available to the participant. Participants will complete questionnaires at baseline and 3 months.
Behavioral: Inspiratory Muscle Training-Rehabilitation
The training will include the following components:
Patient quality of life will be measured using patient-reported outcomes measurement information system (PROMIS) global items. Patients will also complete the Chronic Respiratory Questionnaire (CRQ) and the Medical Research Council Dyspnea Scale (MCR).
- Postoperative Pneumonia [ Time Frame: 3 months ]To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pneumonia in patients that undergo an esophageal surgical resection. The investigators will consider the following as pneumonia: new infiltrate + either fever (>38.5 C) and white cell count >11,000 or fever and purulent secretions.
- Postoperative Pulmonary Complications [ Time Frame: 3 months ]To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pulmonary complications in patients that undergo an esophageal surgical resection.The investigators will consider the following events as post-operative pulmonary complications: severe atelectasis (requiring bronchoscopy) and respiratory failure (intubation or prolonged mechanical ventilation (>24hours).
- Length of Hospital Stay [ Time Frame: 3 months ]Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.
- Quality of Life [ Time Frame: Baseline to 3 months ]Quality of life will be assessed at baseline and at 3 months after hospital discharge by participant completion of the PROMIS Global 10.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843750
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Roberto P Benzo||Mayo Clinic|