A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme
| ISRCTN | ISRCTN47680448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47680448 |
| Protocol serial number | 146/2005 |
| Sponsor | Welsh Assembly Government (UK) |
| Funder | Welsh Assembly Government (UK) (tender contract number: 146/2005) |
- Submission date
- 18/05/2010
- Registration date
- 28/05/2010
- Last edited
- 15/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Murphy
Scientific
Scientific
Cardiff Institute of Society and Health
School of Social Sciences
Cardiff University
Cardiff
CF10 3BD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre pragmatic randomised controlled trial with blind assignment to intervention (exercise referral) or control trial arm (normal care and leaflet) and masked intervention delivery |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of the effectiveness of an exercise referral scheme in increasing physical activity in inactive men and women aged 16+ with coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress |
| Study objectives | Is a national exercise referral scheme more effective in increasing on physical activity and improving mental health in inactive men and women aged 16+ with coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress compared to the provision of an information leaflet and normal care at 12 months follow up? |
| Ethics approval(s) | The Thames Valley Multi-centre Research Ethics Committee (MREC), 08/02/2007, ref: 06/MRE12/85 |
| Health condition(s) or problem(s) studied | Coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress |
| Intervention | A 16 week intervention consisting of an initial and exit consultation with an exercise profession and access to weekly one to one discounted exercise instruction and/or group exercise classes for the period. Participants in the control group receive a leaflet and normal care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Total minutes of weekly activity using the seven day physical activity recall questionnaire (7-DAY PAR) |
| Key secondary outcome measure(s) |
The Hospital Anxiety and Depression Scale (HADS) to assess depression and anxiety, measured at 12 months |
| Completion date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2104 |
| Key inclusion criteria | Sedentary male and females aged 16+ with coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress |
| Key exclusion criteria | 1. Unstable angina 2. Blood pressure 180/100 (in either) or above and/or uncontrolled or poorly controlled hypertension 3. Cardio myopathy 4. Uncontrolled tachycardia 5. Cardiac arrhythmia 6. Valvular heart disease 7. Congenital heart disease 8. Unexplained dizzy spells 9. Excessive or unexplained breathlessness on exertion 10. Uncontrolled or poorly controlled diabetes 11. Uncontrolled or poorly controlled epilepsy 12. History of falls or dizzy spells in the last 12 months 13. Uncontrolled or poorly controlled asthma (severe COPD) 14. First 12 weeks of pregnancy 15. Awaiting medical investigation 16. Aneurysms 17. Cerebro-vascular disease 18. Unstable/newly diagnosed angina (within 6 months) 19. Established coronary heart disease (including myocardial infarction) 20. Any other uncontrolled condition |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 31/10/2008 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff Institute of Society and Health
Cardiff
CF10 3BD
United Kingdom
CF10 3BD
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 | 01/08/2012 | Yes | No | |
| Results article | results | 29/10/2013 | Yes | No | |
| Results article | secondary analysis results | 27/08/2014 | Yes | No | |
| Protocol article | protocol | 18/06/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
