|
ISRCTN
|
ISRCTN17691887
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised controlled trial for the effect of preoperative physiotherapy in patients with an increased risk for the development of postoperative pulmonary complications after open-heart surgery
|
|
Scientific title
|
|
|
Acronym
|
PORT
|
|
Serial number at source
|
ZonMw reference 1310.0004
|
|
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
|
|
Countries of recruitment
|
The Netherlands
|
|
Disease/condition/study domain
|
Postoperative pulmonary complications
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
24/06/2002
|
|
Anticipated end date
|
01/10/2006
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
600
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Length of hospital stay.
|
|
Sources of funding
|
University Medical Center Utrecht (UMCU) (The Netherlands)
|
|
Trial website
|
|
|
Publications
|
Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17047215
2. http://www.ncbi.nlm.nih.gov/pubmed/18062595
|
|
Contact name
|
Dr
H.J.
Hulzebos
|
|
Address
|
University Medical Center Utrecht
Huispost STR 5.203
P.O. Box 85500
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
3508 GA
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)30 253 8484
|
|
Email
|
H.Hulzebos@pmbr.azu.nl
|
|
Sponsor
|
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
|
|
Address
|
P.O. Box 93245
|
|
City/town
|
Den Haag
|
|
Zip/Postcode
|
2509 AE
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)70 349 5111
|
|
Fax
|
+31 (0)70 349 5100
|
|
Email
|
info@zonmw.nl
|
|
Date applied
|
20/12/2005
|
|
Last edited
|
18/03/2008
|
|
Date ISRCTN assigned
|
20/12/2005
|
