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Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery

NCT ID: NCT04717817

Last Updated: 2023-12-12

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Patients eligible for cardiac surgery are pre-operatively randomized to standard physiotherapy or daily inspiratory muscle training for a period of 2-3 weeks. One therapy session a week is supervised by a physiotherapist in the IMT group. Post-operative physiotherapy is standardized. Pulmonary function and clinical status are evaluated pre-operatively, and during the early post-operative phase, approximately on the 3th and 6th post-operative day, or when necessary. The occurrence of postopercenterative pulmonary complications is determined using a validated scale, the Melbourne group scale, based on clinical status, chest x-ray and blood tests. Frailty is defined based on the Fried criteria. Two Belgian hospitals are involved in this study: the University Hospital Brussels and the Jessa Hospital (Hasselt), the latter mainly focussing on patients referred for minimal invasive heart surgery (minimally invasive-aortic valve replacement (mini-AVR) and Endoscopic - Atraumatic Coronary Artery Bypass (endo-ACAB).

Conditions

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

Keywords

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post-operative complications inspiratory muscle training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
lungfunction assessor, radiologist (thorax X-ray) and physician (hospital ward) are blinded

Study Groups

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Group 1: experimental

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Group 2: comparator

Standard physiotherapy prior to surgery

Group Type ACTIVE_COMPARATOR

Standard physiotherapy

Intervention Type OTHER

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

Interventions

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

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

Intervention Type DEVICE

Standard physiotherapy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Verdaet

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Other Identifiers

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001/20200218

Identifier Type: -

Identifier Source: org_study_id