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
Protocol serial number	Version 1 July 2008
Sponsor	James Cook University Hospital (UK)
Funder	James Cook University Hospital (UK)

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

Department of Anaesthesia
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Study information

Primary study design	Observational
Study design	Prosepective observational concurrent validity study
Secondary study design	Cohort study
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Anaesthesia

Middlesbrough
TS4 3BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes