Preoperative Inspiratory Muscle Training in Esophageal Resection

NCT01893008 | Completed

• 1 other identifier: NL43194.041.13
• Study Type: interventional
• Target: 245
• Locations: 4 countries
• Sites: 9

Brief Summary

The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

Conditions

Esophageal Resection Candidates

Keywords

Esophageal cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• Pneumonia incidence

  Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.

  Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (5)

• Length of stay

  Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)

• Duration of mechanical ventilation

  Time between intubation and first extubation (in general no more then 24 hours)

• Respiratory muscle function

  At baseline, before surgery and 3, 6 and 9 days after surgery.

• Pulmonary function

  At baseline, before surgery and 3, 6 and 9 days after surgery.

• Quality of life

  At baseline and 4 weeks after surgery

Study Arms (2)

Usual care + Inspiratory Muscle Training (IMT)

EXPERIMENTAL

Other: Inspiratory Muscle Training (IMT)

Usual care (no IMT)

NO INTERVENTION

Interventions

Inspiratory Muscle Training (IMT) OTHER

The IMT protocol is tailored individually. Inspiratory load is set at 60% of the measured maximal inspiratory pressure (Pimax). The load is incrementally increased based on the rate of perceived exertion (RPE) scored on a scale from 0 to 10 which is scored by the patient after each training session. When patients score an RPE below 7, patients increase the inspiratory load of the threshold device with 5% to guarantee overload during each training session. Patients have to complete 30 dynamic inspiratory efforts twice daily. Patients will be instructed to train at home 7 days a week until surgery with a minimum of 2 weeks. Training will be started after the chemoradiation period (if applicable).

Usual care + Inspiratory Muscle Training (IMT)

Eligibility Criteria

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

You may qualify if:

• (Cognitively) capable to understand and perform a preoperative IMT program
• Surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks
• Willing to sign the informed consent form

You may not qualify if:

• Unable to communicate in Dutch language
• Age \< 18 years
• Participating in a conflicting trial concerning esophageal resection

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (9)

University Hospital Gasthuisberg

Leuven, Belgium

Location

HUS

Helsinki, Finland

Location

St. James's Hospital

Dublin, Ireland

Location

Zorggroep Twente

Almelo, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Atrium Medical Center

Heerlen, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

• Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.

  PMID: 29603130 DERIVED

• Valkenet K, Trappenburg JC, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJ, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EH, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, Backx FJ. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15:144. doi: 10.1186/1745-6215-15-144.

  PMID: 24767575 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Clinical Sports Medicine

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: July 8, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

FI (1); NL (6); IE (1); BE (1)