Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H.J. Hulzebos

ORCID ID

Contact details

University Medical Center Utrecht
Huispost STR 5.203
P.O. Box 85500
Amsterdam
3508 GA
Netherlands
+31 (0)30 253 8484
H.Hulzebos@pmbr.azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw reference 1310.0004

Study information

Scientific title

Acronym

PORT

Study hypothesis

Preoperative physiotherapy decreased the incidence of postoperative pulmonary complications (PPCs) after open heart surgery on patients with an increased risk of developing PPCs.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single blind, active controlled, factorial group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Postoperative pulmonary complications

Intervention

The preoperative physiotherapy consists of a combination of respiratory exercises involving the costo-diaphragm breathing technique, training of the inspiratory muscles for strength and endurance, and teaching a good technique for coughing and 'forced expiration techniques'. The method, involving a progressive training course, is initiated four weeks before the operation.

The training period and progress of the training are sufficient to improve the strength and endurance of the respiratory musculature (also: accessory respiratory muscles). Neuromuscular changes are especially important to increase the efficiency of breathing by the OHS patient. Exercise periods lasting 20 minutes are conducted once per day seven days each week. The therapy is continued by the patient at home, once per week under the supervision of a physiotherapist and six times per week alone. During the supervised training at the beginning and at the end of the period of application, the heart rate and the blood pressure are measured to determine the cardiovascular stress.

In addition the patient keeps a diary, in which he notes the number of exercise sessions completed per week, the duration of each session, and the subjectively experienced stress. In the diary, space is provided for notes regarding physical complaints and problems that occurred before, during or after the exercises.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Postoperative pulmonary complications (PPCs) are defined as 'any pulmonary abnormality occurring in the postoperative period that produces identifiable diseases or dysfunctions that are clinically significant and adversely affect clinical developments' (Brooks-Brunn, 1995). In this study, PPCs are explicitly classified and treated according to the criteria of Kroenke et. al.

Secondary outcome measures

Length of hospital stay.

Overall trial start date

24/06/2002

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Undergo voluntary coronary artery bypass graft (CABG) surgery
2. Have an increased risk of developing a PPC. High risk for the development of PPCs is determined by using the risk model during the preoperative consultation with the anaesthesiologist (6 - 8 weeks before the operation)
3. Understand Dutch language
4. Able to read
5. Capable of passing a spirometer test and a determination of the mouth pressure
6. Prepared to sign a contract of informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

600

Participant exclusion criteria

1. Cerebrovascular illnesses
2. Immunosuppressive treatment less than 30 days before the operation (chemotherapy or radiotherapy)
3. Neuromuscular illnesses (among others Guillein Barre, muscular dystrophy, myasthenia gravis)
4. A previous lung operation
5. Cardiovascular instability
6. The presence of aneurisms
7. Lung physiotherapy less than eight weeks before the operation
8. Postoperative cardiac and/or complications involving the central nervous system

Recruitment start date

24/06/2002

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Amsterdam
3508 GA
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

University/education

Funder name

University Medical Center Utrecht (UMCU) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17047215
2. http://www.ncbi.nlm.nih.gov/pubmed/18062595

Publication citations

  1. Hulzebos EH, Helders PJ, Favié NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL, Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial., JAMA, 2006, 296, 15, 1851-1857, doi: 10.1001/jama.296.15.1851.

  2. Hulzebos EH, Helders PJ, Favié NJ, de Bie RA, Brutel de la Rivière A, van Meeteren NL, [Fewer lung complications following inspiratory muscle training in patients undergoing coronary bypass surgery: a randomized trial]., Ned Tijdschr Geneeskd, 2007, 151, 45, 2505-2511.

Additional files

Editorial Notes