Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery

NCT04717817 | Withdrawn DMC

• 1 other identifier: 001/20200218
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to evaluate the effect of pre-operative Inspiratory muscle training (IMT) using an IMT Threshold device (Philips), on early postoperative lung function recovery and on the occurrence of post-operative pulmonary complications (PPC) after major cardiothoracic surgery with and without sternotomy. As frailty can affect postoperative outcome, the relation between frailty, maximal inspiratory pressure (MIP) and post-operative outcome is investigated additionally.

Conditions

Coronary Artery Bypass Graft Surgery; Valve Replacement; Post-Op Complications; Physiotherapy

Keywords

post-operative complications; inspiratory muscle training

Outcome Measures

Primary Outcomes (6)

• Pulmonary function (Volumes)

  Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction

  Prior to pre-operative physiotherapy

• Pulmonary function (Volumes)

  Inspiratory capacity (l), Functional residual capacity (l), Residual volume (l), Total lung capacity (l).Diagnosis of normal/obstructive/restrictive lungfunction and evolution after pre-operative physiotherapy.

  After 2 weeks of pre-operative physiotherapy (before surgery)

• Pulmonary function (Volumes)

  Inspiratory capacity (l), Functional residual capacity (l) ,Residual volume (l),Total lung capacity (l). Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.

  approximately 6 days after surgery

• Dynamic pulmonary function

  Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction.

  Prior to pre-operative physiotherapy

• Dynamic pulmonary function

  Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Diagnosis of normal/obstructive/restrictive lungfunction and evolution after pre-operative physiotherapy.

  After 2 weeks of pre-operative physiotherapy (before surgery)

• Dynamic pulmonary function

  Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l).Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.

  approximately 6 days after surgery

Secondary Outcomes (12)

• post-operative pulmonary complications

  early post-operative period (day0 - day7)

• Hand grip strength

  Prior to pre-operative physiotherapy

• Hand grip strength

  3 days after surgery

• Hand grip strength

  6 days after surgery

• Respiratory Muscle Strength Test

  Prior the pre-operative physiotherapy

Other Outcomes (1)

• Frailty

  basline, Prior the pre-operative physiotherapy

Study Arms (2)

Group 1: experimental

EXPERIMENTAL

Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery

Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)

Group 2: comparator

ACTIVE COMPARATOR

Standard physiotherapy prior to surgery

Other: Standard physiotherapy

Interventions

Inspiratory muscle training (IMT) using an IMT Threshold device (Philips) DEVICE

Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks

Group 1: experimental

Standard physiotherapy OTHER

Standard instructions and physiotherapy prior to surgery during 2-3 weeks

Group 2: comparator

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for coronary artery bypass grafting or minimally invasive valve repair/replacement

You may not qualify if:

• Not able to perform pre-operative standard pulmonary function tests
• No understanding of Dutch, French or English and/or no ability to understand verbal instructions regarding the inspiratory muscle training
• Patients who participate in another clinical trial
• Patients suffering from neuromuscular disorders, unstable angina, a history of non-traumatic pneumothorax, chronic obstructive pulmonary disease (COPD) in exacerbation
• Patients in need for urgent surgery (within less than 2 weeks)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Hasselt University: collaborator
• Jessa Hospital: collaborator

Study Officials

• Dirk Verdaet

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: lungfunction assessor, radiologist (thorax X-ray) and physician (hospital ward) are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 22, 2021
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 12, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share