跳至主要内容
临床试验/NCT01693536
NCT01693536已完成不适用

Effective Change of Behaviour of the Elderly in Normal General Practice

Health HQ2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2008年10月1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
85
试验地点
2
主要终点
the change in morning urine sodium/potassium ratio

研究概览

简要总结

A randomised controlled trial to test if offering three visits to a dietician + two visits to a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from Oct 2008 to July 2009.

详细描述

There is evidence that both sedentary lifestyle and high sodium diets contribute to cardiovascular disease and possibly dementia among the elderly. There is a need to show that minimal intervention can reduce sodium intake and increase fitness in the elderly. Finland has shown that five dietician visits/year could change diet in respect to fat and fibre. In Australia the National Health Insurer (Medicare) funds five allied health visits/year for those with chronic disease, hence our use of this model. This is consistent with WHO guidelines for a national approach using existing health infrastructure. The elderly (75-95yrs) were chosen as this group is thought most difficult to change behaviour and has a higher incidence of dementia.

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
None

入排标准

年龄范围
75 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Living independently
  • Must be able to walk for six minutes

排除标准

  • Dementia as defined by Standardised Mini-Mental State Examination score <25/30
  • All patients of HealthHQ-Southport General Practice

结局指标

主要结局

the change in morning urine sodium/potassium ratio

时间窗: between enrollment and six months

this measure is to reflect sodium intake. A 24hr urinary sodium cannot be readily validated as an accurate collection and even in the Trials of Hypertension Prevention study was changed to 8hrs to assist compliance. A spot morning ratio is a useful marker of sodium intake for group evaluation.

the increased distance in a six minute walk test

时间窗: between enrollment and six months

to measure objectively an increase in fitness the increase in the six minute walk test was used

次要结局

  • change in systolic BP(between enrollment and six months)
  • change in doses/day of antihypertensive medication(between enrollment and six months)
  • change in waist measurement(between enrollment and six months)
  • change in weight & BMI(between enrollment and six months)
  • change in cognition measurement(between enrollment and six months)

研究者

发起方
Health HQ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Norman Hohl

Medical Director

Health HQ

研究点 (2)

Loading locations...

相似试验