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A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme
ISRCTN ISRCTN47680448
DOI 10.1186/ISRCTN47680448
ClinicalTrials.gov identifier
EudraCT number
Public title A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme
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
Acronym N/A
Serial number at source 146/2005
Study hypothesis 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?
Lay summary Not provided at time of registration
Ethics approval The Thames Valley Multi-centre Research Ethics Committee (MREC) approved the trial on the 8th of February 2007 (Ref: 06/MRE12/85)
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
Countries of recruitment United Kingdom
Disease/condition/study domain Coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress
Participants - inclusion criteria Sedentary male and females aged 16+ with coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress
Participants - 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
Anticipated start date 01/07/2007
Anticipated end date 31/10/2008
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet.
Target number of participants 2,104
Interventions 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.
Primary outcome measure(s) Total minutes of weekly activity using the seven day physical activity recall questionnaire (7-DAY PAR)
Secondary outcome measure(s) The Hospital Anxiety and Depression Scale (HADS) to assess depression and anxiety, measured at 12 months
Sources of funding Welsh Assembly Government (UK) (tender contract number: 146/2005)
Trial website
Publications 1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20565846
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22577180
3. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24164697
Contact name Dr  Simon  Murphy
  Address Cardiff Institute of Society and Health
School of Social Sciences
Cardiff University
  City/town Cardiff
  Zip/Postcode CF10 3BD
  Country United Kingdom
Sponsor Welsh Assembly Government (UK)
  Address Social Research Division (Yr Is-Adran Ymchwil Gymdeithasol)
Department of the First Minister and Cabinet (Adran y Prif Weinidog ar Cabinet)
Welsh Assembly Government (Llywodraeth Cynulliad Cymru)
  City/town Cardiff
  Zip/Postcode CF10 3NQ
  Country United Kingdom
Date applied 18/05/2010
Last edited 30/10/2013
Date ISRCTN assigned 28/05/2010
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