Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Version 1 July 2008
Study information
Scientific title
Acronym
Study hypothesis
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).
Study design
Prosepective observational concurrent validity study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
01/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
200
Participant 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
Recruitment start date
01/10/2008
Recruitment end date
01/10/2010
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Department of Anaesthesia
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
James Cook University Hospital (UK)
Sponsor details
Marton Road
Cleveland
Middlesbrough
TS4 3BW
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.southtees.nhs.uk/live/
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
James Cook University Hospital (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |