| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN32335568 |
| Date ISRCTN assigned | 18/05/2007 |
| Local reference number(s) | 06/Q1003/75 |
| 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 |
| Disease/condition/study domain | Abdominal aortic aneurysms under surveillance |
| Study hypothesis | Anaerobic threshold, as measured by cardiopulmonary exercise testing, increases after a prescribed exercise programme in patients with abdominal aortic aneurysms under surveillance. |
| Design/methodology | Randomised-controlled interventional pilot study |
| Research ethics review | Approval received from the South Tees Local Research Ethics Committee in October 2006 (ref: 06/Q1003/75). |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 23/10/2006 |
| Anticipated end date | 01/04/2007 |
| Status of trial | Completed |
| 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) |
| Sponsor name | South Tees Hospitals NHS Trust (UK) |
| Sponsor details | c/o Miss Karen Stage
Research and Development Department
Marton Road
Middlesbrough
United Kingdom
TS4 3BW |
| Sponsor website | http://www.southtees.nhs.uk/ |
| Contact name | Dr Gerard Danjoux |
| Contact details | Anaesthesia Department
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
United Kingdom
TS43BW |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN32335568 |
| Date last extracted from ISRCTN register | 17/04/2008 |
