Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brian McCloskey

ORCID ID

Contact details

Department of Psychology
Health & Social Care
University College Worcester
Henwick Grove
Worcester
WR2 6AJ
United Kingdom
+44 (0)1905 760023
brian.mccloskey@worc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 99/22/08

Study information

Scientific title

Acronym

EXACT

Study hypothesis

The main objectives of the study are as follows:
1. To compare outcomes for the following treatment strategies for patients with mild to moderate claudication:
1.1. Angioplasty (i.e. status quo treatment)
1.2. Supervised exercise programme
1.3. Exercise and lifestyle advice only (control)
2. To measure the cost of each strategy, including treatment and subsequent health care costs, over 3 years
3. To compare costs and short-term to medium-term (6 months - 3 year) outcomes in different patient groups

Please note that, as of 21/08/2009, the start date of this trial has been updated from 1/09/2001 to 01/12/2001.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular diseases: peripheral arterial disease

Intervention

1. Angioplasty (i.e. status quo treatment)
2. Supervised exercise programme.
3. Exercise and lifestyle advice only (control)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2001

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with claudication

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2001

Recruitment end date

31/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
Worcester
WR2 6AJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16414385

Publication citations

  1. Results

    Hobbs SD, Marshall T, Fegan C, Adam DJ, Bradbury AW, The constitutive procoagulant and hypofibrinolytic state in patients with intermittent claudication due to infrainguinal disease significantly improves with percutaneous transluminal balloon angioplasty., J. Vasc. Surg., 2006, 43, 1, 40-46, doi: 10.1016/j.jvs.2005.09.013.

Additional files

Editorial Notes