Condition category
Circulatory System
Date applied
18/05/2010
Date assigned
28/05/2010
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Murphy

ORCID ID

Contact details

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

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 a’r 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes