Preoperative Inspiratory Muscle Training Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery. (EMI HiPo)

January 16, 2023 updated by: University Hospital, Angers

High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.

This study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • University Hospital Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Waiting for thoracic surgery with valve replacement
  • Preoperative surgeon consultation between 3 and 6 weeks before surgery

Exclusion Criteria:

  • Patient with antecedent of lung surgery
  • Patient with neuromuscular or neurovascular disease
  • Non anticipated surgery with a time between surgeon consultation and surgery inferior to 3 weeks.
  • Inhability to do the preoperative exercises

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham IMT
Preoperative Inspiratory muscle training at low intensity (15% Pimax) which is considered as a no effect training.
Other: Prehabilitation with inspiratory muscle training
3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.
Experimental: Hi Intensity IMT
High intensity muscle training in the preoperative period at 80% of the maximal inspiratory muscle pressure.
Other: Prehabilitation with inspiratory muscle training
3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative STNFr1 level
Time Frame: Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery
Post training and preoperative Serum concentration of the SRNFr1 cytokine.
Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

June 12, 2019

Study Completion (Actual)

January 8, 2021

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A00216-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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