Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT02843750
Status:
WITHDRAWN
Last Update Posted:
2016-12-15
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty recruiting patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2016-07-11', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': '3 months', 'description': 'Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.'}, {'measure': 'Quality of Life', 'timeFrame': 'Baseline to 3 months', 'description': 'Quality of life will be assessed at baseline and at 3 months after hospital discharge by participant completion of the PROMIS Global 10.'}], 'primaryOutcomes': [{'measure': 'Postoperative Pneumonia', 'timeFrame': '3 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pulmonary Complications', 'timeFrame': '3 months', '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Inspiratory Muscle Training'], 'conditions': ['Cancer of Esophagus', 'Cancer of the Esophagus', 'Esophageal Cancer', 'Esophagus Cancer', 'Esophagus Neoplasm', 'Neoplasms, Esophageal']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)\n* Willing to sign the informed consent form\n\nExclusion Criteria:\n\n* Unable to communicate in the English language\n* Participating in a conflicting trial concerning esophageal resection'}, 'identificationModule': {'nctId': 'NCT02843750', 'briefTitle': 'Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery', 'orgStudyIdInfo': {'id': '15-009190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inspiratory Muscle Training-Rehabilitation', '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.', 'interventionNames': ['Behavioral: Inspiratory Muscle Training-Rehabilitation', 'Other: Questionnaires']}], 'interventions': [{'name': 'Inspiratory Muscle Training-Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'The training will include the following components:\n\n1. Breathing Awareness\n2. Upper and Lower Extremity Exercise.\n3. Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve\n4. Practice at home', 'armGroupLabels': ['Inspiratory Muscle Training-Rehabilitation']}, {'name': 'Questionnaires', 'type': 'OTHER', '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).', 'armGroupLabels': ['Inspiratory Muscle Training-Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Roberto P Benzo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Roberto P. Benzo', 'investigatorAffiliation': 'Mayo Clinic'}}}}