Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

Nicola W. Burton, Zanfina Ademi, Stuart Best, Maria A. Fiatarone Singh, Jason S. Jenkins, Kenny D. Lawson, Anthony S. Leicht, Yorgi Mavros, Yian Noble, Paul Norman, Richard Norman, Belinda J. Parmenter, Jenna Pinchbeck, Christopher M. Reid, Sophie E. Rowbotham, Lisan Yip, Jonathan Golledge

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Background: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. Methods: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. Discussion: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. Trial registration: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014.

Original languageEnglish
Article number1148
Pages (from-to)1-14
Number of pages14
JournalBMC Public Health
Issue number1
StatePublished - Nov 9 2016

Bibliographical note

Funding Information:
JG has received research grants from the NHMRC, Queensland Government, The Townsville Hospital Private Practice Research Trust and The Heart Foundation. JG holds an NHMRC Practitioner Fellowship (1019921). AL has received research grants from the NHMRC & The Townsville Hospital Private Practice Research Trust. NB will supervise the allied health interventionists. SB coordinated the trial across sites until July 2016 when JP took over the role. JJ is the lead at, and SR was integral to the establishment of, the Brisbane site. Staff at Townsville: Stuart Best (site coordinator/interventionist until July 2016); Jenna Pinchbeck (interventionist from July 2016); Lisan Yip (assessment/data quality control, site coordinator from July 2016); Cindy Matthews (interventionist from February 2017); Rene Jaeggi (clinical trials manager); Jonathan Golledge (study physician); Ramesh Velu, Nile Allaf and Frank Quigely (recruiting physicians). Staff at Brisbane: Jason Jenkins (site lead), Jessica Suna (interventionist), Roslyn Clapperton (assessment), Sophie Rowbotham (Associate Investigator); Nicolas Boyne, Danella Favot, Allan Kruger, Murray Ogg, Simon Quinn (recruiting physicians).

Funding Information:
This project is supported by funding from the (Australian) National Health & Medical Research Council (NHMRC; APP1063476: Golledge J, Burton NW, Norman P, Fiatarone Singh M, Leicht A, Ademi, Z). This study is also supported by a Centre for Research Excellence grant from the NHMRC (1000967). This funding contributes to costs associated with project staff and participant assessments. These funding bodies have no role in design; the collection, analysis, and interpretation of data; the writing of manuscripts; and the decision to submit the manuscripts for publication.

Funding Information:
The trial will be overseen by a Trial Steering Committee comprising senior vascular investigators from the centers involved; and experts in trial management, physical activity behavior change, health economics and exercise physiology. This will be the main policy and decision-making committee. Trial coordination will be facilitated by the National Health and Medical Research Council (NHMRC) funded National Centre for Research Excellence in Peripheral Arterial Disease (NCRE-PAD). An independent data management center (CCRE therapeutics, Monash University) will provide a computer generated randomisation list. A study coordinator located at James Cook University will organise activities across the participating sites; assisting with local ethics reports and communication with the local sites (including uniformity of collection and reporting of data, central randomisation, data storage and processing). The training, competency assessment, and supervision of allied health professionals who will deliver the intervention and control group protocol; and the intervention fidelity assessment, will be undertaken by a clinical and health psychologist on the investigatory team (NB).

Publisher Copyright:
© 2016 The Author(s).


  • Behavioral health
  • Biomarkers
  • Cardiovascular disease
  • Cost effectiveness
  • Exercise
  • Health counselling
  • Intermittent claudication
  • Multi-disciplinary
  • Physical inactivity
  • Quality of life

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health


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