Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Not Applicable

Withdrawn

• Conditions: Cancer of Esophagus; Esophageal Cancer; Neoplasms, Esophageal; Cancer of the Esophagus; Esophagus Cancer; Esophagus Neoplasm
• Interventions: Behavioral: Inspiratory Muscle Training-Rehabilitation; Other: Questionnaires

• Registration Number: NCT02843750
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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
• Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)
• Willing to sign the informed consent form

Exclusion Criteria

• Unable to communicate in the English language
• Participating in a conflicting trial concerning esophageal resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inspiratory Muscle Training-Rehabilitation	Questionnaires	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.
Inspiratory Muscle Training-Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States