Nutrition Intervention and Physical Training in Malnourished, Frail, Community-dwelling, Elderly Subjects Carried Out by Trained Lay "Buddies"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
研究概览
简要总结
Background: In elderly subjects frailty and malnutrition are very common and can lead to serious health hazards, increase mortality, morbidity, dependency, institutionalization and a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system. Physical training and adequate nutrition can invert it.
Methods/Design: In this randomized, controlled trial 80 malnourished, frail, community-dwelling patients (≥ 65 years) are recruited. Additionally, 80 lay volunteers (≥ 50 years) named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in three standardized training sessions. These buddies visit the malnourished, frail subjects at home twice a week for about one hour during an initial period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct intervention to improve their fluid intake, their protein and energy intake, perform strength training and try to increase their baseline activities, the control group (n=40) only gets home visits without any special intervention. After 10-12 weeks, both, the intervention and the control group, receive the nutrition intervention and the physical training. Health, nutrition and frailty status, physical fitness and body composition and chronic inflammation of buddies and frails are recorded before the intervention, after 10-12 weeks, and after 6 and 12 months.
Discussion: To the investigators knowledge this trial is the first of its kind to provide nutrition and physical activity intervention to malnourished, frail, community-dwelling subjects by trained lay buddies, in which the health status of buddies is also expected to improve. This study assesses the effectiveness of such an intervention. If successful, the intervention offers new perspectives for the management of frailty and malnutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes from baseline in handgrip at 10-12 weeks and at 6 and 12 months
时间窗: Before the intervention, after 10-12 weeks and after 6 and 12 months
次要结局
- Changes from baseline in balance and mobility components at 10-12 weeks and at 6 months(Before the intervenion, after 10-12 weeks and after 6 months)
- Changes from baseline in qualitative and quantitative contents of refrigerator at 10-12 weeks and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in quality of the whole diet at 10-12 week and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Measures of drop-out after 10-12 weeks(Afer 10-12 weeks)
- Measures of adherence after 10 -12 weeks(after 10 -12 weeks)
- Appraisal of the participant after 10-12 weeks(after 10-12 weeks)
- Documentation of any undesirable event during the intervention after 6 months(after 6 months)
- Change from baseline in nutritional status at 10-12 weeks and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Change from baseline is frailty status at 10-12 weeks and at 6 and 12 months(Before the intervention, after 10 -12 weeks and after 6 and 12 months)
- Change from baseline in quality of life at 10-12 weeks and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in social support at 10-12 weeks and at 6 months(before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in sings of malnutrition and frailty at 10-12 weeks and at 6 months(Before the intervention, after 10-12 weeks, and after 6 months)
- Changes from baseline in cognitiv function at 10-12 weeks and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in muscle strength after 10-12 weeks and 6 months(Before the intervention, after 10 -12 weeks and after 6 months)
- Changes from baseline in the amount of physical activity at 10-12 weeks and 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in frequency of hospitalization at 10-12 weeks and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in frequency of falls at 10-12 weeks and 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Changes from baseline in fear of fallings at 10-12 week and at 6 months(Before the intervention, after 10-12 weeks and after 6 months)
- Measures of drop-out after 6 months(Afer 6 months)
- Measures of adherence after 6 months(after 6 months)
- Expectations of the participant before the intervention(Before the intervention)
- Appraisal of the participant after 6 months(after 6 months)
- Documentation of any undesirable event during the intervention after 10-12 weeks(after 10 -12 weeks)
研究者
Priv. Doz. Thomas E. Dorner
Priv. Doz
Medical University of Vienna