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临床试验/NCT03030547
NCT03030547已完成不适用

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Hacettepe University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2016年3月最近更新:
适应症

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
Energy expenditure on SenseWear Activity Monitor

研究概览

简要总结

To evaluate physical activity levels and factors associated with physical activity levels in adult patients with muscle diseases.

详细描述

The same protocol will be applied all of the patients and healthy subjects. Individuals will be informed in detail about the study and demographic and physical properties will recorded after receiving approval. Evaluation programme that consisting of pain, fatigue, falls, activity limitations, quality of life, muscle strength assessment and functional assessment will be applied. After the evaluation, individuals will be given detailed information on the use of SenseWear activity monitors. Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days. The data stored on the device will be recorded in computer using the software. Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity). Physical activity levels will be assessed by subjective aspects of physical activity questionnaire.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of muscle diseases
  • Adult patients with muscle diseases who are able to walk independently

排除标准

  • Clinical diagnosis of systemic problems
  • Any orthopedic problems that will affect the performance of the physical activity
  • Clinical diagnosis of neurological disease other than muscle disease
  • Clinical diagnosis of cognitive impairment
  • Individuals who underwent surgery in the last 6 month

结局指标

主要结局

Energy expenditure on SenseWear Activity Monitor

时间窗: 5 days

The SenseWear software calculates energy expenditure based on a proprietary algorithm that incorporates subject height, weight, age, and sex which are entered prior to data analysis as well as the various measurements (two-axis accelerometry, galvanic skin response, heat flux, skin and near-body temperature).

Number of steps on SenseWear Activity Monitor

时间窗: 5 days

The SenseWear software calculates number of steps based on a proprietary algorithm that incorporates subject height, weight, age, and sex which are entered prior to data analysis.

次要结局

  • International Physical Activity Scale (IPAQ)(10 minutes)
  • Fatigue Severity Scale(5 minutes)
  • Timed Up and Go Test(2 minutes)
  • Hand Held Dynamometry(20 minutes)
  • Visual Analog Scale(2 minutes)
  • ACTIVLIM questionaire(5 minutes)
  • Six Minutes Walk Test(10 minutes)
  • Medical Outcomes Short-Form Health Survey(10 minutes)

研究者

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

Fatma Ayvat

Principal Investigator, Research Assistant

Hacettepe University

研究点 (2)

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