Changing illness perceptions of patients with intermittent claudication: a pilot randomised controlled trial to increase walking
Principal research question:
Will a brief psychological intervention to modify illness perceptions increase walking behaviour for patients with intermittent claudication?
Secondary research questions:
1. Will a brief psychological intervention increase intention to walk?
2. Will a brief psychological intervention increase walking self-efficacy?
3. Will a brief psychological intervention change illness perceptions?
As of 03/11/2009 this record was updated to include an extended anticipated end date; the initial anticipated end date at the time of registration was 01/10/2009.
As of 13/01/2010 this record was updated to include a further extended anticipated end date; the previous anticipated end date at the time of registration was 30/11/2009.
Fife and Forth Valley NHS Research Ethics Committee approved on the 12th February 2008 (ref: 08/S0501/6).
Single-centre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Session 1: one hour in the participant's own home:
1. Modify illness beliefs regarding interpretation of symptoms and chronicity of disease by providing information about disease, and behaviour health link
2. Modify understanding of consequences of disease and future health risk perception by providing information on consequences of disease
3. Operationalise above points 1 and 2 using motivational interviewing
Session 2: one hour in the participant's own home:
4. Improve personal control/self efficacy by prompting specific goal setting for walking; prompt barrier identification to formulate a coping plan
Three follow up phone calls (monthly):
5. Prompt review of behavioural goals through monthly phone calls
6. Provide social support through the inclusion in the intervention of a key partner
Control group receives usual care and phone calls to minimise social support effects.
Total duration of treatment is 2 hours. Follow-up for both arms is at 4 months, however an amendment to ethical approval has been submitted to carry out long-term follow-ups at 1 year and 2 years after recruitment.
Primary outcome measure
Increase in walking behaviour as measured by pedometer (mean daily steps measured over 1 week at each time point) at baseline, 4 months, and 1 year and 2 years (subject to the approval of the amendment).
Secondary outcome measures
All outcomes will be measured at baseline, 4 months, and 1 year and 2 years (subject to the approval of the amendment):
1. Self-report physical activity, measured with the International Physical Activity Questionnaire (IPAQ)
2. Quality of life, measured with the Intermittent Claudication Questionnaire (ICQ)
3. Psychological outcomes, measured with a range of psychological questionnaires adapted for use in this study
4. Clinical outcome, measured by type of treatment received or scheduled by each time point e.g. angioplasty, bypass graft, conservative treatment
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Newly diagnosed patients with intermittent claudication
2. English speaking
3. Aged over 55 years, either sex
Target number of participants
Participant exclusion criteria
1. Severe cardiac disease
2. Patients unable to perform simple exercise test at slow speed
3. Severe debility, e.g., arthritis
4. History of orthopaedic surgery
5. Ankle Brachial Blood Pressure Index (ABPI) at diagnosis of less than 0.35
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Stirling (UK)
Head of Psychology Department
University of Stirling (UK) - Internally funded PhD
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)
Cunningham MA, Swanson V, O'Carroll RE, Holdsworth RJ, Increasing walking in patients with intermittent claudication: protocol for a randomised controlled trial., BMC Cardiovasc Disord, 2010, 10, 49, doi: 10.1186/1471-2261-10-49.
Cunningham MA, Swanson V, O'Carroll RE, O'Caroll RE, Holdsworth RJ, Randomized clinical trial of a brief psychological intervention to increase walking in patients with intermittent claudication., Br J Surg, 2012, 99, 1, 49-56, doi: 10.1002/bjs.7714.
Cunningham MA, Swanson V, Holdsworth RJ, O'Carroll RE, Late effects of a brief psychological intervention in patients with intermittent claudication in a randomized clinical trial., Br J Surg, 2013, 100, 6, 756-760, doi: 10.1002/bjs.9100.