Mild to moderate claudication: the cost-effectiveness of supervised exercise programmes in patient management.
| ISRCTN | ISRCTN90757358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90757358 |
| Protocol serial number | HTA 99/22/08 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | EXACT |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with claudication |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Psychology
Worcester
WR2 6AJ
United Kingdom
WR2 6AJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
