A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme

ISRCTN ISRCTN47680448
DOI https://doi.org/10.1186/ISRCTN47680448
Secondary identifying numbers 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

Cardiff Institute of Society and Health
School of Social Sciences
Cardiff University
Cardiff
CF10 3BD
United Kingdom

Study information

Study designSingle centre pragmatic randomised controlled trial with blind assignment to intervention (exercise referral) or control trial arm (normal care and leaflet) and masked intervention delivery
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet.
Scientific titleA 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 objectivesIs 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) studiedCoronary heart disease risk factors and / or mild to moderate depression, anxiety or stress
InterventionA 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 typeOther
Primary outcome measureTotal minutes of weekly activity using the seven day physical activity recall questionnaire (7-DAY PAR)
Secondary outcome measuresThe Hospital Anxiety and Depression Scale (HADS) to assess depression and anxiety, measured at 12 months
Overall study start date01/07/2007
Completion date31/10/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants2,104
Key inclusion criteriaSedentary male and females aged 16+ with coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress
Key exclusion criteria1. 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 enrolment01/07/2007
Date of final enrolment31/10/2008

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Cardiff Institute of Society and Health
Cardiff
CF10 3BD
United Kingdom

Sponsor information

Welsh Assembly Government (UK)
Government

Social Research Division (Yr Is-Adran Ymchwil Gymdeithasol)
Department of the First Minister and Cabinet (Adran y Prif Weinidog a’r Cabinet)
Welsh Assembly Government (Llywodraeth Cynulliad Cymru)
Cardiff
CF10 3NQ
United Kingdom

ROR logo "ROR" https://ror.org/000wh6t45

Funders

Funder type

Government

Welsh Assembly Government (UK) (tender contract number: 146/2005)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 18/06/2010 Yes No
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