Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Esophageal Cancer Clinical Trial

Official title:

A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02843750
• Other study ID #: 15-009190
• Status: Withdrawn
• Phase: N/A
• First received: July 11, 2016
• Last updated: December 14, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 99 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of the Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Esophagus Cancer
• Esophagus Neoplasm
• Neoplasms
• Neoplasms, Esophageal
• Respiratory Aspiration

Intervention

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).

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Hospital Stay	Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.	3 months	No
Other	Quality of Life	Quality of life will be assessed at baseline and at 3 months after hospital discharge by participant completion of the PROMIS Global 10.	Baseline to 3 months	No
Primary	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.	3 months	No
Secondary	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).	3 months	No