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临床试验/NCT01609608
NCT01609608已完成不适用

Whole-Body Vibration for Functional Constipation: A Single-Center, Single-Blinded, Randomized, Controlled Trial

Changhua Christian Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2009年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
change from baseline in constipation severity instrument (CSI) at 2 weeks

研究概览

简要总结

  1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced via a non-invasive oscillation platform could improve symptoms and health-related quality of life (HRQOL) in patients with chronic functional constipation.
  2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III diagnostic criteria were included and randomized to either the WBV treatment or no treatment (control) group. The treatment group received six 15-minute sessions of WBV therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a frequency of 12 Hz. The primary outcome was assessed by the constipation severity instrument (CSI). The secondary outcome was improvements in HRQOL.

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • met the Rome III criteria of constipation

排除标准

  • cardiovascular disease
  • cerebrovascular disease
  • recently undergone major surgery
  • hypothyroidism
  • depressive disorder.

研究组 & 干预措施

vibration

Experimental

干预措施: whole body vibration (Procedure)

placebo

Placebo Comparator

干预措施: whole body vibration (Procedure)

结局指标

主要结局

change from baseline in constipation severity instrument (CSI) at 2 weeks

时间窗: baseline (day 1), the completion of the trial (day 14)

次要结局

  • change from baseline in health-related quality of life (HRQOL) at 2 weeks(baseline (day 1), the completion of the trial (day 14))

研究者

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

Tsung Ju Wu

Medical doctor

Changhua Christian Hospital

研究点 (2)

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