Increasing Physical Activity in Stroke Survivors Using STARFISH, an Interactive Mobile Phone Application: a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The number of steps taken per day by participants in each group
研究概览
简要总结
There is good evidence of the effectiveness of regular physical activity in the primary and secondary prevention of stroke. STARFISH is a smartphone-based application designed as a behavioural change intervention to encourage the user to become more physically active. The study will investigate if using STARFISH for 6 weeks can increase physical activity in people after stroke. Subjects will be randomised to the STARFISH intervention or a control group. Control subjects will not have access to their daily activity count.
详细描述
Introduction Stroke is one of the leading causes of long-term disability in western countries (Donan et al. 2008). Stroke survivors are often deconditioned and predisposed to a sedentary lifestyle that limits performance of activities of daily living, increases the risk for falls, and may contribute to a heightened risk for recurrent stroke and cardiovascular disease (Ivey et al. 2005). There is good evidence of the effectiveness of regular physical activity (PA) in the primary and secondary prevention of several chronic diseases e.g. stroke, cardiovascular disease, diabetes, colon cancer, breast cancer, hypertension, obesity and osteoporosis (Warburton et al. 2006). Walking may be one of the most accessible forms of exercise in the stroke population. STARFISH is a mobile phone application designed to encourage the user to become more physically active. Phase 1 of the project will involve the development of the current STARFISH to ensure it is fit for purpose for people following stroke. This will be done in collaboration with stroke survivors and their family if necessary. The study will investigate if using STARFISH for 6 weeks can increase physical activity and if the programme has the potential to improve health and well being in people following stroke, including those with residual, physical, sensory and visual impairment.
Description of STARFISH The current version of STARFISH is a smartphone-based programme designed as a behavioural change intervention to encourage the user to become more physically active. The sensors within a standard smartphone record the number of steps taken per day by the individual. Each person is represented by a fish within a fish tank which the participant can see on their mobile phone display. When the participant is active their fish blows bubbles and swims faster and, as the participant reaches their target number of steps per day, their fish's fins and tail grow.
Aims and Objectives The overall aims are to adapt STARFISH for use in stroke survivors and to undertake a feasibility study to evaluate the acceptability and potential effectiveness of STARFISH in this group.
The objectives are:
- To use a participatory co-design approach to develop the STARFISH software and interfaces to ensure that STARFISH is fit for purpose for use by people with stroke.
- To explore the likely effectiveness of STARFISH in increasing levels of PA in people post stroke.
- To explore the likely acceptability of STARFISH by people post stroke.
- To provide sufficient data on effect sizes of STARFISH on outcomes related to amount of physical activity undertaken, quality of life, general well-being and fatigue, walking speed, and metabolic health biomarkers (BMI, blood pressure, lipid profile, resting heart rate) to undertake power calculations to establish the sample size required for a fully powered, randomised controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post stroke survivors of single unilateral stroke
- •discharged from rehabilitation
- •the ability to walk independently, with or without using an aid or orthosis
- •sufficient cognitive ability,
- •the ability to comprehend instruction
排除标准
- •history of serious cardiac disease (e.g. myocardial infarction, unstable angina)
- •uncontrolled blood pressure
- •significant neurological or musculoskeletal conditions in addition to stroke
结局指标
主要结局
The number of steps taken per day by participants in each group
时间窗: at baseline & at 6 weeks post randomisation
次要结局
- The Ten-Meter Walking Test (10 MWT) assessing walking speed (m/sec) over a 10m distance(at baseline & at 6 weeks post randomisation)
- Fatigue Severity Scale (FSS) (evaluates the impact of fatigue)(at baseline & at 6 weeks post randomisation)
- Instrumental Activities of Daily Living Scale(at baseline & at 6 weeks post randomisation)
- Stroke Specific Quality of Life Scale (SS-QOL)(at baseline & at 6 weeks post randomisation)
- Psychological General Well-Being (PGWB) Index(at baseline & at 6 weeks post-randomisation)
