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临床试验/NCT02494245
NCT02494245Unknown不适用

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

University of Glasgow4 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
128
试验地点
4
主要终点
Change in the mean number of steps per day

研究概览

简要总结

The aim of the study is to compare physical activity in stroke survivors who have undertaken a four month physical activity intervention using the STARFISH application with a control group receiving four months of usual care.

详细描述

Stroke is one of the most common disabling conditions worldwide. The various physical impairments that arise from stroke may encourage a physically inactive lifestyle (Michael et al. 2005). Ninety percent of stroke survivors have some functional disability with reduced mobility being the major impairment (Gresham et al. 1975). Stroke survivors generally spend less time physically active and more time sedentary than their age-matched healthy counterparts (Alzahrani et al. 2011; Michael and Macko 2007; Rand et al. 2010) Physical inactivity following a stroke is associated with decreased muscle strength and cardiovascular fitness, decreased ability to perform activities of daily living and a heightened risk for recurrent stroke and cardiovascular disease (Ivey et al. 2005). Cardiovascular disease is the leading cause of death in chronic stroke. Inactivity and low cardiovascular fitness are two of the modifiable risk factors associated with cardiovascular disease. Activities which promote mobility and fitness are therefore vital for the prevention of further cardiovascular events.

The previous Chest, Heart and Stroke, Scotland (CHSS) funded pilot study demonstrated that community dwelling stroke survivors are significantly less physically active and spend significantly more time sedentary compared to healthy, matched controls. (Paul et al. 2015). The investigators have also reported that using the STARFISH smartphone app (described below) for six weeks had a positive effect on physical activity These pilot results support the development of a fully powered, randomised controlled trial.

Starfish description Research team members have developed STARFISH, a smartphone app, which aims to encourage users to become more physically active. The sensors within a standard smartphone record the number of steps taken per day by the individual.

STARFISH is undertaken in groups of four to facilitate social support and each group member receives a personalised daily step count target. Each person is represented by coloured fish, and participants can see their own and other group members' fish in a fish tank on their smartphone. When the participant is walking, their fish swims and blows bubbles and, as participants progress towards their daily step count target, their fish's fins and tail grow. When all group members reach their target on five days of the week, the group is rewarded by another sea creature appearing in their fish tank (e.g. a seahorse).

Aims and Objectives

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
Single (Outcomes Assessor)

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

  • single unilateral stroke
  • discharged from active rehabilitation
  • the ability to walk independently, with or without using an aid or orthosis
  • the ability to comprehend instruction

排除标准

  • a history of serious cardiac disease (e.g. myocardial infarction, unstable angina) in the previous six months
  • uncontrolled blood pressure
  • significant neurological or musculoskeletal conditions in addition to stroke
  • currently participating in another clinical trial (rehabilitation or pharmacological)

结局指标

主要结局

Change in the mean number of steps per day

时间窗: Baseline, 4 months, 6 months

measured with an ActivPAL activity monitor (PAL Technologies, Glasgow, Scotland)

次要结局

  • Change in sedentary time(Baseline, 4 months, 6 months)
  • Change in the Six-Minute Walk Test (6MWT)(Baseline, 4 months, 6 months)
  • change in 10-Metre Walking Test (10MWT)(Baseline, 4 months, 6 months)
  • Change in the Nottingham Extended Activities of Daily Living Scale (EADL)(Baseline, 4 months, 6 months)
  • Change in Fatigue Severity Scale (FSS)(Baseline, 4 months, 6 months)
  • Change in Stroke Specific Quality of Life Scale (SS-QOL)(Baseline, 4 months, 6 months)
  • change in The Hospital Anxiety and Depression Scale (HADS)(Baseline, 4 months, 6 months)
  • change in blood pressure(Baseline, 4 months, 6 months)
  • Change in weight in kg(Baseline, 4 months, 6 months)
  • Change in plasma lipid profile(Baseline, 4 months, 6 months)
  • Change in heart rate(Baseline, 4 months, 6 months)
  • Change in walking time(Baseline, 4 months, 6 months)
  • Change in walking intensity(Baseline, 4 months, 6 months)
  • liver function (ALT, AST, GGT)(Baseline, 4 months, 6 months)
  • Change in C-reactive protein level (CRP, a marker of inflammation)(Baseline, 4 months, 6 months)
  • Change in HBA1c(Baseline, 4 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Lorna Paul

Reader in Rehabilitation

University of Glasgow

研究点 (4)

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