Physical activity has been referred to as a 'miracle cure' because of the potential health benefits that can accrue from being regularly active . The current physical activity recommendation for health improvement and maintenance for older adults is to achieve 30 minutes of moderate intensity physical activity on most days of the week . Throughout this paper the term 'older adult' will be used to refer to an individual aged ≥65 years. The proportion of adults meeting the physical activity guideline on at least five days of the week in Scotland declines with increasing age; 78% of men and 83% of women aged 65-74 years and 89% of men and 94% of women aged ≥75 years currently do not meet that recommendation . The Scottish physical activity strategy "let's make Scotland more active" has a target of 50% of adults meeting the physical activity recommendation by 2022 . Older adults are a key segment of the population for physical activity intervention if Scotland is to reach the 2022 target, because of the low proportion of older adults meeting the physical activity guideline  and an ageing population structure . In addition, older adults may have the most to gain from physical activity intervention as a consequence of physical [7–9] and cognitive [10, 11] functions deteriorating with age. Being regularly physically active has physiological (e.g. reduced risk of overall mortality, cardiovascular disease, obesity, Type 2 diabetes, osteoporosis and breast and colo-rectal cancer), psychological (e.g. reduced anxiety and depression risk and reduced risk or decreased rate of dementia and memory loss development), social (e.g. interaction) and overall well-being benefits (e.g. increased energy, vitality and improved mood and sleep pattern) [2, 12]. Regular physical activity has a number of benefits that are particularly important for older adults. It can: a) slow the age-related decline in functional capacity; b) improve mobility and independence thus making activities of daily living easier; c) slow age-related declines in cognition or even improve cognitive functioning; d) reduce the risk of falling; and e) benefit areas of mental health such as social interaction and overall well-being [2, 12–14].
Walking is an ideal mode of physical activity for older adults and has been described as 'the nearest activity to perfect exercise'  (p. 328) as it is a cheap and safe way of increasing physical activity participation with minimal adverse effects . For previously sedentary adults, walking can result in physiological health benefits including decreases in body weight, body mass index, percentage body fat and resting diastolic blood pressure  as well as psychological health benefits such as positive effects on mood . In a systematic review by Ogilvie et al.  of the evidence for successful walking interventions, the authors identified a lack of peer reviewed literature on how best to support older people. The authors also concluded that walking interventions tailored to the individual and delivered on a one-to-one, household or group basis are the most successful at encouraging increases in walking participation in those that are most sedentary and/or most motivated to change . The review found evidence that pedometers are effective tools to increase walking participation in adults but there is a need for research to examine who can benefit the most from pedometer-based walking programmes and which elements of the interventions are most important to their success. In addition, the review called for studies to be conducted outside of the USA and Australia where most of the current literature was generated and also to focus on longer term effects.
There is growing interest around the world in the health implications of sedentary behaviour (time spent sitting and lying), independent of physical activity levels. A number of recent policy documents have highlighted concern about the high levels of sedentary behaviours in the Scottish population [4, 19]. Recent evidence suggests a dose-response association between sitting times and mortality from all causes and cardiovascular disease, independent of leisure time physical activity . If an individual achieves the recommended amount of physical activity, his/her health may still be at risk if sedentary for many hours. Recent research from Australia suggests that those who spend more time in sedentary behaviour but are sufficiently active (at least 2.5 hrs of activity/week) and those who are insufficiently active but spend less time in sedentary behaviours have a similar risk of being overweight or obese . A study using the activ PAL™ to assess activity patterns in 20 older Scottish adults (mean age 74.0 ± 5.3 years) found that on average 18 hours/day were spent in sedentary behaviours .
Previous research conducted by our group found a 12-week individualised pedometer-based graduated walking programme ('Walking for Well-being in the West'(WWW)), delivered with a series of physical activity consultations, significantly increased walking behaviour, improved mood and decreased self reported sitting time in Scottish adults aged 18-65 years [17, 23] over a 3 month period. The WWW intervention was based on the recommendations from Ogilvie and colleagues' review , consisting of a one-to-one, theory-driven, individualised programme. The consultation was based on established guidelines  and adapted for walking behaviour. Specific behaviour change techniques that were used included information provision on the link between walking and health, setting graded tasks (pedometer step counts), identifying barriers and ways to overcome them, prompting self-monitoring by use of the pedometer, identifying social support and relapse prevention. All of these techniques have been recognised as having evidence for behaviour change and are used as described by Abraham et al. . The methods of the present study will determine if the same intervention that was used in WWW could be used to increase walking behaviour in adults aged ≥65 years who do not currently meet the physical activity recommendations.
WWW was based in a community setting but delivered by a research team. Little is known regarding the feasibility of delivering such walking interventions by professionals (not researchers) through primary care. Therefore this study was based in a primary care setting, specifically in a general practice (family practice) and delivered by a practice nurse. Recruitment was via a general practice in this study for two main reasons. Firstly, it is a convenient location to reach older adults, as older adults attend their general practice regularly and more often than younger individuals. General practitioner (family physician) consultation rates in Scotland increase from the 45-54 year age group upwards . In Scotland, 97% of the population is registered with a general practitioner/health practitioner  and 84% of patients have visited their local general practice team at least once in 2008/2009 . Secondly, the 'let's make Scotland more active'  strategy recommended that all patients coming into contact with primary care professionals should be offered counselling for physical activity tailored to individual needs. Thus there is a need to determine practical strategies that such professionals could use. A general practice setting was selected to facilitate future implementation via primary care. This study will explore the use of a non-physician delivery model by employing a practice nurse as the intervention deliverer. Given time constraints on physicians, the use of non-physician delivery models has been recognised as a significant research area . Appropriately trained nurses have been shown to produce equally high quality care as primary care doctors and achieve equally as good health outcomes for patients .
In 2008 National Health Service (NHS) Health Scotland developed a resource ('Energising Lives' ) for primary care staff and other health professionals to 'provide guidance on how to offer routine advice and encouragement to patients around physical activity' (p. 5) by including information on the benefits of physical activity and the physical activity recommendations for health. Although there have been various types of engagement across primary care to increase physical activity participation, there is currently no consensus evidence as to what is the best approach to promoting physical activity via primary care settings. Previous physical activity intervention studies delivered via primary care were reviewed by the National Institute for Health and Clinical Excellence (NICE)  in 2006. Eleven studies were included in the review, with six studies reporting significant increases in physical activity. The interventions included brief verbal advice, referrals, and motivational interviews delivered by health promotion specialists or researchers. Two studies delivered brief verbal advice and significantly increased physical activity [31, 32]. There are limitations with the evidence from these studies. Specifically, both studies lacked a control condition, were based in New Zealand and Australia rather than the UK, used subjective measures of activity, and used a general practitioner/family physician to deliver the intervention (a model unlikely to be adopted in the UK due to constraints on general practitioner time). Of eight UK based studies conducted in primary care since the publication of the NICE guidelines which offered exercise/physical activity support [33–40], only one of these specifically targeted older adults (women aged ≥70 years) ) and four included an objective assessment of physical activity [36–39] (although one study used self-reported step counts as opposed to monitoring stored counts ). Four of the eight studies incorporated a pedometer into their intervention [33, 37–39]. The results suggested pedometer use can increase physical activity via primary care, and one study reported a 101% increase in step counts after 12 weeks . From these primary care-based studies it can be summarised that there is a paucity of research conducted in the UK looking at physical activity interventions that: a) target older adults; b) measure physical activity objectively to assess the efficacy of the interventions; c) have a graduated pedometer-based walking programme based on the current physical activity recommendations; and d) do not use highly trained members of primary care or researchers to recruit participants, deliver the intervention and perform follow-up appointments.
The West End Walkers study (WEW65+) has been designed as an exploratory trial, as described in phase II of the Medical Research Council's framework for the evaluation of complex interventions  and as a feasibility and pilot study, as described by the National Institute for Health Research Evaluation . A feasibility/pilot study not only tests (on a smaller level than a main study) the likely efficacy of the intervention (such as the anticipated effect size of the primary outcome) but also tests whether all elements of the planned study can be implemented in practice and work together . Such pilot work, when combined with a feasibility study, also tests intervention characteristics such as anticipated levels of recruitment, how easily the intervention can be implemented by the planned delivery team and whether the intervention is appropriate (e.g. in terms of time commitment, technological and skills demands, and accessibility) for the target population. The design and appropriateness of the intervention and the research protocol and how they impact on these issues (e.g. delivery, recruitment, uptake, retention, calibration, ease of data collection, implications of data for subsequent analysis) are vital for the success of both a pilot study and any subsequent full trial. To ensure that this pilot study took account of prior evidence and theory about behaviour change, implementation failures, and engagement in research, a logic model was developed of the initial protocol and this model was used along with key criteria from the RE-AIM framework , to strengthen our research plans. A separate paper has been written to describe this process (Blamey A, MacMillan F, Evans A, Fitzsimons C, Mutrie N: Using programme theory to strengthen research protocol and intervention design: A randomised controlled trial of a walking intervention for older adults (West End Walkers 65+), submitted). These steps were taken to strengthen the robustness of the pilot, to enhance the study protocol for a potential larger trial and enhance the generalisability of learning for general practice from both of these research stages.
To summarise, this study was designed to fill several research gaps in the literature. This study will explore the efficacy of a walking intervention (already shown to successfully increase walking in young to middle-aged adults ) in a randomised controlled trial with an older adult population in the UK and using an objective measurement of physical activity. The efficacy of the intervention on areas of health important to older adults will also be assessed using specific questionnaires shown to be valid and reliable measures in adult groups. The appropriateness of the physical activity recommendations and the walking intervention for older adults will also be explored. In addition this study will examine the feasibility of delivering the walking intervention in a primary care setting (general practice) to provide a practical solution to increasing physical activity levels of older adults, facilitating future implementation via this setting. The study will also look at the feasibility of delivering the walking intervention by a practice nurse (a more likely delivery mode in the UK than via general practitioners who have greater time constraints). Older adults were specifically targeted in this study due to the low proportion of Scottish older adults that currently meet the physical activity recommendations . Participants were recruited via a general practice as a means of accessing older adults, due to the high proportion of older adults that attend their general practice in Scotland .
This paper provides details of the rationale and study design (including information on the outcome measures assessed and recruitment process). The WEW65+ study aims to examine the delivery of a pedometer-based graduated walking programme in combination with physical activity consultations, through a primary care setting (general practice), to older Scottish adults who are currently not meeting the physical activity recommendations. The feasibility issues are: recruitment of participants into the study (who is targeted versus who is actually recruited) and delivery of the intervention via a primary care setting (general practice); delivery of the intervention by a practice nurse; practicality of administering the outcome measures; and whether the intervention is acceptable and enjoyable for an older adult population in a real-life setting. Determining the efficacy of the intervention in an older adult population (≥65 years) is also a pilot element of this study as the intervention has previously been shown to successfully increase walking participation in adults aged 18-65 years  but has not been tested in older adults. For the pilot component of this study, efficacy of the intervention will be evaluated by looking at the effect of the intervention on step counts (primary outcome), activity patterns and sedentary behaviour, mood, quality of life, perceived motor-efficacy and loneliness (secondary outcomes). Another pilot element of this study will be to assess if all components of the study can be implemented simultaneously and work together to have an effect on physical activity before planning a full trial.
The main research questions are:-
Is the recruitment and retention strategy successful?
Is the intervention acceptable, appropriate, accessible and useable for this group?
What is the efficacy of the intervention on outcome measures?
Are the outcome measures acceptable for this group?