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临床试验/NCT01792349
NCT01792349Unknown不适用

Increasing Physical Activity in Stroke Survivors Using STARFISH, an Interactive Mobile Phone Application: a Feasibility Study

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年2月最近更新:
适应症

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:

  1. 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.
  2. To explore the likely effectiveness of STARFISH in increasing levels of PA in people post stroke.
  3. To explore the likely acceptability of STARFISH by people post stroke.
  4. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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