- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04717817
Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery (PRIMUS)
December 5, 2023 updated by: Universitair Ziekenhuis Brussel
The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
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.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
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).
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dirk Verdaet
- Phone Number: 0032 2 477 6025
- Email: dirk.verdaet@uzbrussel.be
Study Contact Backup
- Name: Dominique Hansen, Professor
- Phone Number: 0032 11 29 21 26
- Email: dominique.hansen@uhasselt.be
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: experimental
Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery
|
Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks
|
Active Comparator: Group 2: comparator
Standard physiotherapy prior to surgery
|
Standard instructions and physiotherapy prior to surgery during 2-3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary function (Volumes)
Time Frame: Prior to pre-operative physiotherapy
|
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)
Time Frame: After 2 weeks of pre-operative physiotherapy (before surgery)
|
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)
Time Frame: approximately 6 days after surgery
|
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
Time Frame: Prior to pre-operative physiotherapy
|
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
Time Frame: After 2 weeks of pre-operative physiotherapy (before surgery)
|
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
Time Frame: approximately 6 days after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-operative pulmonary complications
Time Frame: early post-operative period (day0 - day7)
|
Melbourne Group Scale (MGS), tool for recognition of postoperative pulmonary complications (PPC), based on 1) Temperature >38◦C 2)White blood cell count >11.2 or the use of respiratory antibiotics 3)Physician diagnosis of pneumonia or chest infection 4)Chest X-ray report of atelectasis/pneumonia 5)Production of purulent (yellow/green)sputum differing from preoperative 6)Positive signs on sputum microbiology 7)SpO2<90% on room air 8)Re-admission to or prolonged stay (over36 hours) on the intensive care unit/highdependency unit for respiratory problems.
Postoperative pulmonary complications are defined as a score of four or more positive variables.
the occurence of PPC is an endpoint in this study.
|
early post-operative period (day0 - day7)
|
Hand grip strength
Time Frame: Prior to pre-operative physiotherapy
|
Evaluation of hand grip strength using a Martin Vigorimeter
|
Prior to pre-operative physiotherapy
|
Hand grip strength
Time Frame: 3 days after surgery
|
Evaluation of hand grip strength using a Martin Vigorimeter
|
3 days after surgery
|
Hand grip strength
Time Frame: 6 days after surgery
|
Evaluation of hand grip strength using a Martin Vigorimeter
|
6 days after surgery
|
Respiratory Muscle Strength Test
Time Frame: Prior the pre-operative physiotherapy
|
Maximum inspiratory pressure (MIP)
|
Prior the pre-operative physiotherapy
|
Respiratory Muscle Strength Test
Time Frame: After 1 week of pre-operative physiotherapy
|
Maximum inspiratory pressure (MIP)
|
After 1 week of pre-operative physiotherapy
|
Respiratory Muscle Strength Test
Time Frame: After 2 weeks of pre-operative physiotherapy (before surgery)
|
Maximum inspiratory pressure (MIP)
|
After 2 weeks of pre-operative physiotherapy (before surgery)
|
Respiratory Muscle Strength Test
Time Frame: 3 days after surgery
|
Maximum inspiratory pressure (MIP)
|
3 days after surgery
|
Respiratory Muscle Strength Test
Time Frame: 6 days after surgery
|
Maximum inspiratory pressure (MIP)
|
6 days after surgery
|
CRP
Time Frame: Prior the pre-operative physiotherapy
|
C-reactive protein, evaluation inflammatory status
|
Prior the pre-operative physiotherapy
|
CRP
Time Frame: 3 days after surgery
|
C-reactive protein, evaluation inflammatory status
|
3 days after surgery
|
CRP
Time Frame: 6 days after surgery
|
C-reactive protein, evaluation inflammatory status
|
6 days after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty
Time Frame: basline, Prior the pre-operative physiotherapy
|
Frailty measured by the SHARE-FI, SHARE Frailty instrument
|
basline, Prior the pre-operative physiotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dirk Verdaet, Universitair Ziekenhuis Brussel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
January 5, 2021
First Submitted That Met QC Criteria
January 15, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001/20200218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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