Cardiopulmonary exercise testing: does anaerobic threshold increase after a prescribed exercise programme in patients with abdominal aortic aneurysms under surveillance?

ISRCTN	ISRCTN32335568
DOI	https://doi.org/10.1186/ISRCTN32335568
Protocol serial number	06/Q1003/75
Sponsor	South Tees Hospitals NHS Trust (UK)
Funder	Small grant from the South Tees Research and Development Department (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gerard Danjoux
Scientific

Anaesthesia Department
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS43BW
United Kingdom

Primary study design	Interventional
Study design	Randomised-controlled interventional pilot study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Anaerobic threshold, as measured by cardiopulmonary exercise testing, increases after a prescribed exercise programme in patients with abdominal aortic aneurysms under surveillance.
Ethics approval(s)	South Tees Local Research Ethics Committee in October 2006 (ref: 06/Q1003/75).
Health condition(s) or problem(s) studied	Abdominal aortic aneurysms under surveillance
Intervention	Cardiopulmonary exercise tests - the subjects have to complete this in week zero, five and seven of the study (the control and the exercise groups both complete these tests). Six week prescribed supervised exercise programme to complete in week one to six of the study. This comprises two 30 minute exercise sessions per week (only the exercise group undergoes the prescribed exercise programme).
Intervention type	Other
Primary outcome measure(s)	Improvement in anaerobic threshold between week zero and week seven.
Key secondary outcome measure(s)	Improvement in anaerobic threshold between week zero and week five.
Completion date	01/04/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	1. Abdominal aortic aneurysm patients under surveillance 2. Size of aneurysm less than 5.5 cm in diameter
Key exclusion criteria	1. Medical exclusions to exercise - severe aortic stenosis, hypertrophic cardiomyopathy 2. Inability to climb a flight of stairs (baseline level of fitness) 3. Inability to complete the cardiopulmonary exercise test
Date of first enrolment	23/10/2006
Date of final enrolment	01/04/2007

Anaesthesia Department

Middlesbrough
TS43BW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No