Mild to moderate claudication: the cost-effectiveness of supervised exercise programmes in patient management.
| ISRCTN | ISRCTN90757358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90757358 |
| Secondary identifying numbers | HTA 99/22/08 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 21/08/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Brian McCloskey
Scientific
Scientific
Department of Psychology
Health & Social Care
University College Worcester
Henwick Grove
Worcester
WR2 6AJ
United Kingdom
| Phone | +44 (0)1905 760023 |
|---|---|
| brian.mccloskey@worc.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2001 |
| Overall study end date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | Patients with claudication |
| 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
- England
- United Kingdom
Study participating centre
Department of Psychology
Worcester
WR2 6AJ
United Kingdom
WR2 6AJ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2006 | Yes | No |
