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临床试验/NCT01421628
NCT01421628已完成不适用

The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People

Hanze University of Applied Sciences Groningen2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
2
主要终点
Nocturnal cramps

研究概览

简要总结

Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.

详细描述

The ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and ADL performance. This circle can be reversed by physical exercise to increase physical fitness.

The goal of this research is to establish the effects of a trainings program on ADL performance, physical fitness and nocturnal cramps. Furthermore the characteristics from participants who benefit from the program will be investigated by the research.

The study design is a randomized intervention study. Participants are elderly people, age 65 years and older, without cognitive impairment.

Intervention: The intervention is a physical trainings program. The intensity is moderate, the frequency is daily and the total duration is 6 weeks. The control group will be provided with an education program.

Main parameters are: physical fitness, nocturnal cramp severity and frequency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • For patients to be included in our study, they had to experience regular episodes of NLC and are in good mental health.
  • The participants had to agree to the study protocol and complete the program.
  • After eligibility was verified, written informed consent was obtained.

排除标准

  • Older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.

研究组 & 干预措施

exercise

Experimental

干预措施: Fitness exercise program (Other)

结局指标

主要结局

Nocturnal cramps

时间窗: Six weeks

Visual analogue scale (VAS)

Physical fitness

时间窗: six weeks

Strength, balance

ADL performance

时间窗: six weeks

Performance based ADL test

Well being

时间窗: six weeks

Questionnaires like SF-36

次要结局

  • Frequency nocturnal cramp(Six weeks)

研究者

发起方
Hanze University of Applied Sciences Groningen
申办方类型
Other

研究点 (2)

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