NCT03574480已完成不适用
Effectiveness of the Combined Use of Smartphone and Smartband Technology in the Improvement of Lifestyles in the Adult Population Over 65 Years of Age. Randomized Clinical Trial. EVIDENT Age Study
Fundacion para la Investigacion y Formacion en Ciencias de la Salud2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
This is a randomized controlled clinical trial performed in urban primary care centers in Salamanca (Spain). Its objective is to evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age in the improvement of lifestyles, body composition, quality of life, cognitive performance and daily life activities.
详细描述
- Objective: To evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age.
- Design and setting: A randomized clinical trial of two parallel groups. Population: 140 participants over 65 years of age will be included, selected by consecutive sampling in primary care centers of Salamanca (Spain.
- Measurements and intervention: Lifestyles (physical activity, sedentarism and mediterranean diet), body composition, health-related quality of life, cognitive performance and daily life activities will be evaluated at 3 months. The advice on healthy diet and physical activity recommendations will be common to both groups. The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent signed
- •Age between 65 and 80 years
排除标准
- •Cardiovascular disease
- •Moderate or severe chronic obstructive pulmonary disease.
- •Musculoskeletal disease that limits ambulation.
- •Severe mental illness
- •Score in the Mini-mental <24 points.
- •Oncological disease in treatment.
结局指标
主要结局
Physical activity
时间窗: 3 months
Measurement by accelerometer (steps/day)
次要结局
- Cognitive performance(3 months)
- Body composition(3 months)
- Improve Quality of life(3 months)
- Adherence to the Mediterranean Diet(3 months)
- Daily life activities(3 months)
- Sedentarism(3 months)
研究者
研究点 (2)
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