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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03158402
Other study ID # 2017-A00216-47
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2018
Est. completion date January 8, 2021

Study information

Verified date January 2023
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 8, 2021
Est. primary completion date June 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
France University Hospital Angers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (1)

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: 10.1080/09 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative STNFr1 level Post training and preoperative Serum concentration of the SRNFr1 cytokine. Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery
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