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Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

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ClinicalTrials.gov Identifier: NCT02843750
Recruitment Status : Withdrawn (Difficulty recruiting patients)
First Posted : July 26, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Roberto P. Benzo, 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.

Condition or disease Intervention/treatment Phase
Cancer of Esophagus Cancer of the Esophagus Esophageal Cancer Esophagus Cancer Esophagus Neoplasm Neoplasms, Esophageal Behavioral: Inspiratory Muscle Training-Rehabilitation Other: Questionnaires Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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:

  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

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).




Primary Outcome Measures :
  1. Postoperative Pneumonia [ Time Frame: 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 :
  1. Postoperative Pulmonary Complications [ Time Frame: 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:
  1. Length of Hospital Stay [ Time Frame: 3 months ]
    Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.

  2. Quality of Life [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843750


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Roberto P Benzo Mayo Clinic
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Responsible Party: Roberto P. Benzo, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02843750    
Other Study ID Numbers: 15-009190
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Roberto P. Benzo, Mayo Clinic:
Rehabilitation
Inspiratory Muscle Training
Additional relevant MeSH terms:
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Neoplasms
Esophageal Neoplasms
Respiratory Aspiration
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes