|
ISRCTN
|
ISRCTN32335568
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Cardiopulmonary exercise testing: does anaerobic threshold increase after a prescribed exercise programme in patients with abdominal aortic aneurysms under surveillance?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
06/Q1003/75
|
|
Study hypothesis
|
Anaerobic threshold, as measured by cardiopulmonary exercise testing, increases after a prescribed exercise programme in patients with abdominal aortic aneurysms under surveillance.
|
|
Ethics approval
|
Approval received from the South Tees Local Research Ethics Committee in October 2006 (ref: 06/Q1003/75).
|
|
Study design
|
Randomised-controlled interventional pilot study
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Abdominal aortic aneurysms under surveillance
|
|
Participants - inclusion criteria
|
1. Abdominal aortic aneurysm patients under surveillance
2. Size of aneurysm less than 5.5 cm in diameter
|
|
Participants - 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
|
|
Anticipated start date
|
23/10/2006
|
|
Anticipated end date
|
01/04/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
30
|
|
Interventions
|
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).
|
|
Primary outcome measure(s)
|
Improvement in anaerobic threshold between week zero and week seven.
|
|
Secondary outcome measure(s)
|
Improvement in anaerobic threshold between week zero and week five.
|
|
Sources of funding
|
Small grant from the South Tees Research and Development Department (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Gerard
Danjoux
|
|
Address
|
Anaesthesia Department
Cheriton House
James Cook University Hospital
Marton Road
|
|
City/town
|
Middlesbrough
|
|
Zip/Postcode
|
TS43BW
|
|
Country
|
United Kingdom
|
|
Sponsor
|
South Tees Hospitals NHS Trust (UK)
|
|
Address
|
c/o Miss Karen Stage
Research and Development Department
Marton Road
|
|
City/town
|
Middlesbrough
|
|
Zip/Postcode
|
TS4 3BW
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.southtees.nhs.uk/
|
|
Date applied
|
20/12/2006
|
|
Last edited
|
18/05/2007
|
|
Date ISRCTN assigned
|
18/05/2007
|
