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
| ISRCTN | ISRCTN17691887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17691887 |
| Secondary identifying numbers | ZonMw reference 1310.0004 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 28/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H.J. Hulzebos
Scientific
Scientific
University Medical Center Utrecht
Huispost STR 5.203
P.O. Box 85500
Amsterdam
3508 GA
Netherlands
| Phone | +31 (0)30 253 8484 |
|---|---|
| H.Hulzebos@pmbr.azu.nl |
Study information
| Study design | Multicentre, randomised, single blind, active controlled, factorial group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | PORT |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 24/06/2002 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 600 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/06/2002 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Amsterdam
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
University/education
University Medical Center Utrecht (UMCU) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/10/2006 | Yes | No | ||
| Results article | 10/11/2007 | Yes | No | ||
| Results article | Secondary analysis | 16/04/2016 | 28/10/2022 | Yes | No |
Editorial Notes
28/10/2022: Publication reference added.
