Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

NCT02843750 | Withdrawn

• 1 other identifier: 15-009190
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Rehabilitation; Inspiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative Pulmonary Complications

  3 months

Other Outcomes (2)

• Length of Hospital Stay

  3 months

• Quality of Life

  Baseline to 3 months

Study Arms (1)

Inspiratory Muscle Training-Rehabilitation

EXPERIMENTAL

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; Other: Questionnaires

Interventions

Inspiratory Muscle Training-Rehabilitation 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

Inspiratory Muscle Training-Rehabilitation

Questionnaires 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).

Inspiratory Muscle Training-Rehabilitation

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to communicate in the English language
• Participating in a conflicting trial concerning esophageal resection

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Roberto P Benzo

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 26, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 15, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)