Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
146/2005
Study information
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
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?
Ethics approval
The Thames Valley Multi-centre Research Ethics Committee (MREC), 08/02/2007, 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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Total minutes of weekly activity using the seven day physical activity recall questionnaire (7-DAY PAR)
Secondary outcome measures
The Hospital Anxiety and Depression Scale (HADS) to assess depression and anxiety, measured at 12 months
Overall trial start date
01/07/2007
Overall trial end date
31/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Sedentary male and females aged 16+ with coronary heart disease risk factors and / or mild to moderate depression, anxiety or stress
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2,104
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
31/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiff Institute of Society and Health
Cardiff
CF10 3BD
United Kingdom
Sponsor information
Organisation
Welsh Assembly Government (UK)
Sponsor details
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)
Cardiff
CF10 3NQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Welsh Assembly Government (UK) (tender contract number: 146/2005)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20565846
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22577180
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24164697
2014 secondary analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/25209188
Publication citations
-
Protocol
Murphy S, Raisanen L, Moore G, Edwards RT, Linck P, Williams N, Ud Din N, Hale J, Roberts C, McNaish E, Moore L, A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation., BMC Public Health, 2010, 10, 352, doi: 10.1186/1471-2458-10-352.
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Results
Murphy SM, Edwards RT, Williams N, Raisanen L, Moore G, Linck P, Hounsome N, Din NU, Moore L, An evaluation of the effectiveness and cost effectiveness of the National Exercise Referral Scheme in Wales, UK: a randomised controlled trial of a public health policy initiative., J Epidemiol Community Health, 2012, 66, 8, 745-753, doi: 10.1136/jech-2011-200689.
-
Results
Edwards RT, Linck P, Hounsome N, Raisanen L, Williams N, Moore L, Murphy S, Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial., BMC Public Health, 2013, 13, 1021, doi: 10.1186/1471-2458-13-1021.
-
Secondary analysis results
Littlecott HJ, Moore GF, Moore L, Murphy S, Psychosocial mediators of change in physical activity in the Welsh national exercise referral scheme: secondary analysis of a randomised controlled trial., Int J Behav Nutr Phys Act, 2014, 11, 1, 109, doi: 10.1186/s12966-014-0109-9.