A Randomized, Controlled Pilot Study of a Home-based Self-management Exercise Program for Sedentary Individuals With Mild Disability After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline physical activity level at 3 months and 6 months
研究概览
简要总结
Practising physical activity after a stroke is essential for the secondary prevention of stroke. However, the major individuals after stroke are sedentary. Individuals after stroke with mild disabilities could have fewer barriers to this practice. Thus, finding ways to promote physical activity after stroke in these individuals is important for them and public health. Interventions that consider behaviour change strategies are a good way to change a habit and could improve physical activity levels. Self-management interventions have been used to promote behaviour change in the stroke population.
The aim of this pilot trial will be to determine the efficacy of a self-management program to increase physical activity levels in stroke survivors with mild disability through 6 home-based sessions of self-management exercise over 3 and 6 months in a low-income country. Our secondary aims are to evaluate the effect of a self-management program on walking, exercise self-efficacy, participation, quality of life, depression and cardiovascular risks after 3 and 6 months.
详细描述
One-quarter of stroke events in the world are recurrent. Stroke secondary prevention is essential for this population and health politics. The practice of a physical activity is a good option to reduce the chance to develop a second stroke. Self-management interventions have been used in the stroke population to increase physical activity. However, a review showed that the efficacy of this intervention to improve physical activity is inconclusive. Recently, a study of feasibility made in Brazil about the self-management approach showed positive results in this intervention to increase physical activity after stroke survivors with mild impairment. In addition, the results can be more beneficial for sedentary individuals. The aim of this study will be to test the efficacy of a home-based self-management exercise intervention to improve physical activity levels in sedentary individuals with a mild disability after stroke. The specific questions are:
In sedentary individuals with a mild disability after stroke,
- Is a home-based self-management exercise effective in improving physical activity effective at increasing the number of steps taken per day?
- Does any improvement in physical activity carry over to improvements in cardiovascular risk, walking ability, depressive symptoms, exercise self-efficacy, social participation and quality of life?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •time since stroke less than 6 months;
- •≥18 years of age;
- •be able to walk 10 meters independently at a speed ≥ 0.8 m/s without any walk devices;
- •had no cognitive impairments (determined by the cut-off scores on the Brazilian version of the Mini-Mental State Examination);
- •be sedentary (steps counts less than 5000 steps/day).
排除标准
- •have other neurological diseases (e.g. Parkinson, Multiple Sclerosis);
- •had comprehensive aphasia (evaluated by simple motor command: "lift your good arm and raise your hand");
- •have any other conditions that would prevent participation.
结局指标
主要结局
Change from baseline physical activity level at 3 months and 6 months
时间窗: 3 months, and 6 months
We will measure the level of physical activity through steps taken per day using the Actigraph wGT3X-BT. The participants will be informed to use the device during the waking hours, except during water activities.
次要结局
- Body mass index(3 months, and 6 months)
- Waist circumference(3 months, and 6 months)
- Walking speed(3 months, and 6 months)
- Social participation(3 months, and 6 months)
- Blood pressure(3 months, and 6 months)
- Self-Efficacy for exercise(3 months, and 6 months)
- Walking capacity(3 months, and 6 months)
- Depression(3 months, and 6 months)
- Perception of quality of life(3 months, and 6 months)
研究者
Aline Alvim Scianni
Associate Professor in Physical Therapy Department
Federal University of Minas Gerais