PACE-UP (Pedometer and consultation evaluation - UP) – a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45–75 years: study protocol for a randomised controlled trial

Trials PACE-UP (Pedometer and consultation evaluation - UP) - a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-75 years: study protocol for a randomised controlled trial Tess Harris Sally M Kerry Christina R Victor 0 Sunil M Shah Steve Iliffe Michael Ussher Ulf Ekelund Julia Fox-Rushby Peter Whincup Lee David Debbie Brewin Judith Ibison Stephen DeWilde Elizabeth Limb Nana Anokye Cheryl Furness Emma Howard Rebecca Dale Derek G Cook 0 Gerontology and Health Services Research Unit, Brunel University , London UB8 3PH , UK Background: Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults' most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45-75 year olds to increase their PA over 12 months. Methods/design: Design: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations. Participants: Less active 45-75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed. Intervention: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care. Outcomes: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count (Continued on next page) - (Continued from previous page) and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions acceptability. Discussion: The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 4575 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed. Trial registration: ISRCTN98538934 Background Benefit and risks of PA and current PA guidelines Why is physical activity (PA) important for adults and older adults? PA leads to reduced mortality, a reduced risk of over 20 diseases and conditions, and improved function, quality of life and emotional well-being [1]. Physical inactivity is the fourth leading risk factor for global mortality [2] and a major cost burden on health services [1]. What are the PA guidelines? Adults and older adults are advised to be active daily and, in order to obtain health benefits, should achieve at least 150 minutes (2 hours) per week of at least moderate intensity activity in bouts of 10 minutes or more. One effective way to do this is by 30 minutes of moderate intensity activity on at least 5 days weekly [1,3,4]. Regular walking is the most common PA of adults and older adults, walking at a moderate pace (3 mph /5 km/h) qualifies as moderate intensity PA [5]. Time spent being sedentary for extended periods should also be minimised, as this is an independent disease risk factor [1] and increases steeply from the age of 45 [6]. Whilst amongst adults in England aged 16 and over, 39% of men and 29% of women were judged to meet the recommended PA levels, based on their self-reported data, only 20% and 17% of men and women aged 6074 met recommended levels [6], despite most of these inactive older people being capable of walking [7]. Lower socioeconomic groups [6] and Indian, Pakistani, Bangladeshi and Chinese ethnic groups are significantly less likely to report activity levels that meet the recommended levels, whilst the activity levels of other ethnic groups (Black Caribbean, Black African and Irish) are similar to that of the general population [8]. Surveys of adults in Europe and the USA also confirm that over 50% do not achieve public health PA recommendations [9,10]. Since PA, including walking, is unreliably recalled, surveys may overestimate PA levels [11]. Objective accelerometer measurement found that only 5% of men and 4% of women aged 3564 years and 5% men and 0% of women aged 65 or more achieved the recommended PA levels, only a fraction of those self-reporting achieving these levels [6]. What are the risks from increasing PA? Risks from a sedentary lifestyle far exceed the risks from regular PA [3,12,13]. Moderate intensity PA carries a low injury risk [14], mainly musculoskeletal injury or falls [15]. Walking is very low risk, a near perfect exercise [5]. Screening participants for contraindications before participating in light to moderate intensity PA programmes is no longer advocated [3,16]. An important safety feature of our study is that individualised goals can be set from the participants own baseline, in line with advice that older adults in particular should start with low intensity PA and increase intensity gradually, the start-low-and-goslow approach [12,13]. Strategies for increasing PA How can adults and older adults increase their PA levels? A systematic review of PA interventions reported moderate positive short-term effects, but findings were limited by mainly unreliable self-report measures in motivated volunteers [17]. Effective interventions explored factors associated with behavioural change, including beliefs about costs and benefits of PA [18]. Exercise programs in diverse populations can promote short- to medium-term increases in PA when interventions are based on health behaviour theoretical constructs, individually tailored with personalised activity goals and use behavioural strategies [3,19]. A critical review and a best practices statement on older peoples PA interventions advised home rather than gym-based programmes and behavioural strategies (e.g., goal-setting, self-monitoring, self-efficacy, support, relapse prevention training) rather than health education alone [ (...truncated)