Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Cancer of Esophagus Cancer of the Esophagus Esophageal Cancer Esophagus Cancer Esophagus Neoplasm Neoplasms, Esophageal

Interventions

Inspiratory Muscle Training-RehabilitationBEHAVIORAL

The training will include the following components: 1. Breathing Awareness 2. Upper and Lower Extremity Exercise. 3. Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve 4. Practice at home

QuestionnairesOTHER

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).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Postoperative Pneumonia

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.

Time frame: 3 months

Secondary Outcomes

Postoperative Pulmonary Complications

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).

Time frame: 3 months

Data from ClinicalTrials.gov

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