Validity of the six minute walk test as a surrogate for the anaerobic threshold in the pre-operative assessment clinic
| ISRCTN | ISRCTN55875201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55875201 |
| Secondary identifying numbers | Version 1 July 2008 |
- Submission date
- 10/10/2008
- Registration date
- 28/11/2008
- Last edited
- 28/03/2013
- 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 Gerard Danjoux
Scientific
Scientific
Department of Anaesthesia
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study information
| Study design | Prosepective observational concurrent validity study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | The aim of this study is to examine the validity of the six minute walk test (6MWT) (maximum distance walked; undertaken at pre-operative assessment for scheduled major non-cardiac surgery) against two criterion measures derived from cardiopulmonary exercise testing (CPET) - anaerobic threshold (AT) and peak oxygen consumption (VO2 peak). |
| Ethics approval(s) | South Humber Research Ethics Committee gave approval on the 27th August 2008 (ref: 08/H1305/62). |
| Health condition(s) or problem(s) studied | Pre-operative assessment |
| Intervention | This is a concurrent validity study. In practice all participants will complete two exercise tests during their attendance at the pre-operative assessment clinic. After gaining consent the participants will first perform a cardiopulmonary exercise test using a cycle ergometer. Then after a rest period they will complete a supervised six minute walk test. The results of the two tests will be read after completion. Patient characteristics and risk assessment data will be collected from the notes during the clinic. The participant will have no further involvement after this clinic attendance. We will collect post-hoc surgical outcome data after discharge from hospital. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The outcome of a concurrent validity study is determined by the two criterion measures (AT and VO2 peak) and the two predictors (walking distance and body weight product). This will allow us to calculate the typical predictive error in the estimation of AT from the results of a 6MWT. This is measured during clinic attendance. |
| Secondary outcome measures | Recorded after discharge from hospital: 1. Morbidity and mortality, 30-day mortality also collected 30 days from discharge 2. Length of stay in critical care, measured in days 3. Length of stay in hospital, measured in days 4. Further measures of pre-operative assessment will be analysed in order to best assess the estimation of exercise capacity |
| Overall study start date | 01/10/2008 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Aged between 50 and 85 years of age, either sex 2. Awaiting major surgery for: colorectal resection, upper gastrointestinal tract disease, major vascular procedures, major urological and major gynaecological procedures 3. Identified through the surgical pre-operative assessment clinics where participants are routinely assessed prior to surgery |
| Key exclusion criteria | 1. Emergency surgery 2. Aged less than 50 and greater than 85 years 3. Medical conditions causing inability to walk 4. Unable to complete baseline CPET test 5. Unable to give informed consent 6. Medical contraindications to CPET and 6MWT: 6.1. New York Heart Association Functional Classification greater than or equal to Class III 6.2. Canadian Cardiovascular Society Angina Grading Scale greater than or equal to Class III 6.3. European Society of Hypertension Classification Grades greater than or equal to III 7. Aortic stenosis greater than or equal to moderate (i.e. valve area less than 1.0 cm^2) 8. Hypertrophic cardiomyopathy 9. Symptomatic arrhythmias 10. Spinal cord injury 11. Primary muscular disorder 12. Uncontrolled epileptic seizures 13. Pregnancy |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
James Cook University Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Marton Road
Cleveland
Middlesbrough
TS4 3BW
England
United Kingdom
| Website | http://www.southtees.nhs.uk/live/ |
|---|---|
"ROR" |
https://ror.org/02vqh3346 |
Funders
Funder type
Hospital/treatment centre
James Cook University Hospital (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
