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

NCT ID: NCT03158402

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2021-01-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Surgery Prehabilitation Respiratory Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sham IMT

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

Group Type SHAM_COMPARATOR

Prehabilitation with inspiratory muscle training

Intervention Type OTHER

3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.

Hi Intensity IMT

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

Group Type EXPERIMENTAL

Prehabilitation with inspiratory muscle training

Intervention Type OTHER

3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prehabilitation with inspiratory muscle training

3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Angers

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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. 2024 Apr;40(4):778-788. doi: 10.1080/09593985.2022.2163212. Epub 2023 Jan 13.

Reference Type RESULT
PMID: 36637368 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A00216-47

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Inspiratory Muscular Training
NCT01593007 COMPLETED NA
Inspiratory Muscle Training in HFpEF
NCT06510231 RECRUITING NA