Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Study Details
Study Description
Brief Summary
To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
Breathing Awareness
Upper and Lower Extremity Exercise.
Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve
Practice at home
Other: Questionnaires
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).
|
Outcome Measures
Primary Outcome Measures
- Postoperative Pneumonia [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.
Secondary Outcome Measures
- Postoperative Pulmonary Complications [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).
Other Outcome Measures
- Length of Hospital Stay [3 months]
Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.
- Quality of Life [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients diagnosed with esophageal cancer and scheduled for esophageal resection at the Mayo Clinic Rochester with gastric conduit reconstruction -Cognitively capable to understand and perform a preoperative program
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Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)
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Willing to sign the informed consent form
Exclusion Criteria:
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Unable to communicate in the English language
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Participating in a conflicting trial concerning esophageal resection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Roberto P Benzo, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-009190