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临床试验/NCT02582138
NCT02582138Unknown不适用

Sarcopenia and Physical fRailty IN Older People: Multi-componenT Treatment Strategies (SPRINTT)

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
2
主要终点
Incident of major mobility disability

研究概览

简要总结

The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme (physical activity, nutritional counselling/dietary intervention, and information and communications technology intervention) compared with a healthy aging lifestyle education programme on mobility disability, in non-disabled older people with physical frailty and sarcopenia.

详细描述

As the life expectancy in European countries continues to increase, the maintenance of physical independence in older persons has become a major public health priority. The ability to ambulate without assistance is crucial for independent living and it is often the first ability to be lost in the process leading to disability. Older people who have impaired walking function need more assistance and are more likely to be placed in nursing homes, have a higher risk of morbidity, mortality and hospitalisation, and experience a reduced quality of life. The ultimate goals of the Sarcopenia and Physical fRailty IN older people: multicomponenT Treatment strategies (SPRINTT) project are to offer efficient treatment options, based on a multicomponent intervention including physical activity, nutrition and information and communications technology, to physically frail, sarcopenic older persons and to improve their quality of life. The result will directly contribute to the long-term sustainability and efficiency of health- and social-care systems. The conceptualisation of physical frailty and sarcopenia (PF&S) as proposed in SPRINTT will promote significant advancements over the traditional approaches by enabling the precise operationalisation of the condition, a clear identification of the affected population and the rapid translation of findings to the clinical arena.

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
Single (Outcomes Assessor)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incident of major mobility disability

时间窗: 36 months

Incident inability to complete the 400-metre walk test (incidence of major mobility disability)

次要结局

  • Changes in body mass index(36 months)
  • Changes in mid-arm circumference(36 months)
  • Changes in hip circumference(36 months)
  • Changes in mood(36 months)
  • Changes in lower extremity physical performance(36 months)
  • Persistent mobility disability(36 months)
  • Changes in nutritional status(36 months)
  • Incidence of injurious falls(36 months)
  • All-cause mortality(36 months)
  • Changes in crude appendicular lean mass(36 months)
  • Changes in upper extremity muscle strength(36 months)
  • Changes in functional status (instrumental activities of daily living)(36 months)
  • Changes in waist circumference(36 months)
  • Changes in calf circumference(36 months)
  • Changes in body mass index-adjusted appendicular lean mass(36 months)
  • Changes in cognitive function(36 months)
  • Changes in functional status (activities of daily living)(36 months)
  • Changes in body weight(36 months)
  • Incidence of self-reported falls(36 months)
  • Changes in quality of life(36 months)
  • Changes in the use of healthcare services(36 months)
  • Cost effectiveness(36 months)

研究者

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

Roberto Bernabei

Professor of Geriatrics

Catholic University of the Sacred Heart

研究点 (2)

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