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Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

NCT ID: NCT02843750

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Rehabilitation Inspiratory Muscle Training

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training-Rehabilitation

Intervention Type BEHAVIORAL

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

Questionnaires

Intervention Type OTHER

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).

Interventions

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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

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Roberto P. Benzo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto P Benzo

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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15-009190

Identifier Type: -

Identifier Source: org_study_id