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

Primary Purpose

Thoracic Surgery, Prehabilitation, Respiratory Therapy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prehabilitation with inspiratory muscle training
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thoracic Surgery focused on measuring Inspiratory muscle training, Systemic Inflammatory Response Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

sham IMT

Hi Intensity IMT

Arm Description

Preoperative Inspiratory muscle training at low intensity (15% Pimax) which is considered as a no effect training.

High intensity muscle training in the preoperative period at 80% of the maximal inspiratory muscle pressure.

Outcomes

Primary Outcome Measures

Preoperative STNFr1 level
Post training and preoperative Serum concentration of the SRNFr1 cytokine.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2017
Last Updated
January 16, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03158402
Brief Title
Preoperative Inspiratory Muscle Training Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery.
Acronym
EMI HiPo
Official Title
High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Prehabilitation, Respiratory Therapy
Keywords
Inspiratory muscle training, Systemic Inflammatory Response Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham IMT
Arm Type
Sham Comparator
Arm Description
Preoperative Inspiratory muscle training at low intensity (15% Pimax) which is considered as a no effect training.
Arm Title
Hi Intensity IMT
Arm Type
Experimental
Arm Description
High intensity muscle training in the preoperative period at 80% of the maximal inspiratory muscle pressure.
Intervention Type
Other
Intervention Name(s)
Prehabilitation with inspiratory muscle training
Intervention Description
3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.
Primary Outcome Measure Information:
Title
Preoperative STNFr1 level
Description
Post training and preoperative Serum concentration of the SRNFr1 cytokine.
Time Frame
Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Angers
City
Angers
ZIP/Postal Code
49000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36637368
Citation
Furon Y, Dang Van S, Blanchard S, Saulnier P, Baufreton C. Effects of high-intensity inspiratory muscle training on systemic inflammatory response in cardiac surgery - A randomized clinical trial. Physiother Theory Pract. 2023 Jan 13:1-11. doi: 10.1080/09593985.2022.2163212. Online ahead of print.
Results Reference
result

Learn more about this trial

Preoperative Inspiratory Muscle Training Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery.

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