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

NCT03158402 | Completed

• 1 other identifier: 2017-A00216-47
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Prehabilitation; Respiratory Therapy

Keywords

Inspiratory muscle training; Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

sham IMT

SHAM COMPARATOR

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

Other: Prehabilitation with inspiratory muscle training

Hi Intensity IMT

EXPERIMENTAL

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

Other: Prehabilitation with inspiratory muscle training

Interventions

Prehabilitation with inspiratory muscle training OTHER

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

Hi Intensity IMT; sham IMT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital Angers

Angers, 49000, France

Location

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

  PMID: 36637368 RESULT

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: February 14, 2018
• Primary Completion: June 12, 2019
• Study Completion: January 8, 2021
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

FR (1)