Back to resultsStudy of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Primary Purpose
Cancer of Esophagus, Cancer of the Esophagus, Esophageal Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Muscle Training-Rehabilitation
Questionnaires
Sponsored by
About this trial
This is an interventional prevention trial for Cancer of Esophagus focused on measuring Rehabilitation, Inspiratory Muscle Training
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inspiratory Muscle Training-Rehabilitation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02843750
Brief Title
Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Official Title
A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty recruiting patients
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Esophagus, Cancer of the Esophagus, Esophageal Cancer, Esophagus Cancer, Esophagus Neoplasm, Neoplasms, Esophageal
Keywords
Rehabilitation, Inspiratory Muscle Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory Muscle Training-Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory Muscle Training-Rehabilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative Pneumonia
Description
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 Outcome Measure Information:
Title
Postoperative Pulmonary Complications
Description
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
Other Pre-specified Outcome Measures:
Title
Length of Hospital Stay
Description
Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.
Time Frame
3 months
Title
Quality of Life
Description
Quality of life will be assessed at baseline and at 3 months after hospital discharge by participant completion of the PROMIS Global 10.
Time Frame
Baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
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