Condition category
Circulatory System
Date applied
20/12/2006
Date assigned
18/05/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerard Danjoux

ORCID ID

Contact details

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

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

http://www.southtees.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes