Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06/Q1003/75
Study information
Scientific title
Acronym
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
South Tees Local Research Ethics Committee in October 2006 (ref: 06/Q1003/75).
Study design
Randomised-controlled interventional pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Improvement in anaerobic threshold between week zero and week seven.
Secondary outcome measures
Improvement in anaerobic threshold between week zero and week five.
Overall trial start date
23/10/2006
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Abdominal aortic aneurysm patients under surveillance
2. Size of aneurysm less than 5.5 cm in diameter
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant 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
Recruitment start date
23/10/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthesia Department
Middlesbrough
TS43BW
United Kingdom
Sponsor information
Organisation
South Tees Hospitals NHS Trust (UK)
Sponsor details
c/o Miss Karen Stage
Research and Development Department
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Small grant from the South Tees Research and Development Department (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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19628486
Publication citations
-
Results
Kothmann E, Batterham AM, Owen SJ, Turley AJ, Cheesman M, Parry A, Danjoux G, Effect of short-term exercise training on aerobic fitness in patients with abdominal aortic aneurysms: a pilot study., Br J Anaesth, 2009, 103, 4, 505-510, doi: 10.1093/bja/aep205.