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临床试验/NCT04069988
NCT04069988已完成不适用

Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia: A Randomized Controlled Trial

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 92 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
92
试验地点
2
主要终点
body Mass Index

研究概览

简要总结

Baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia.

Aim This study was to explore the effect of Baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia.

Methods We recruited 92 participants from 3 chronic wards and nursing homes in eastern and northern Taiwan. Participants were assigned by blocked randomization into experimental group and control group. Those in the experimental group received 60 minutes, three times a week for 12 weeks of Baduanjin program training, while those in the control group received physical activity for thirty minutes. We collected the blood pressure, fasting blood sugar, triglyceride, high density cholesterol, waist circumference, and body mass index three times: before the intervention, end of the intervention immediately and 3-month follow up. Chi-squared and independent samples t test were used to compare the groups differences in the demographic characteristics and outcome indicators at the baseline for male and female separately. Demographic variables were controlled. Generalized Estimating Equations (GEE) were used to examine the effects of groups, time, group and time interaction by sex.

详细描述

This study explored the effect of Baduanjin on metabolic parameters and body mass index in people with schizophrenia. We recruited 92 participants from 3 rehabilitation units in Taiwan. Participants were assigned by blocked randomization into an experimental group or control group. Those in the experimental group received 60 minutes of Baduanjin three times a week for 12-weeks, while those in the control group received physical activity for thirty minutes. We assessed five metabolic parameters and body mass index at three timepoints: baseline, posttest and 3-month follow up.

研究设计

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

盲法说明

The data of the five metabolic indexes, height, and bodyweight were collected by a research assistant.

入排标准

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

入选标准

  • diagnosis of schizophrenia
  • between 20-65 years of age
  • BMI ≥ 24 kg/m2 or at least one metabolic parameter abnormality
  • ability to listen, speak and write Chinese
  • no additional exercise beyond normal exercise.

排除标准

  • patients in acute phase requiring hospitalization;
  • patients with severe and unstable

结局指标

主要结局

body Mass Index

时间窗: 6 months

BMI is defined as Body weight(kilograms) divided by height (meter) squared

Waist circumference

时间窗: 6 months

Change from Baseline Waist circumference (inches) at 3 months and 6 months

high-density lipoprotein

时间窗: 6 months

Change from Baseline high-density lipoprotein (mg/dl) at 3 months and 6 months

Fasting blood sugar

时间窗: 6 months

Change from Baseline Fasting blood sugar (mg/dl) at 3 months and 6 months

Blood pressure

时间窗: 6 months

Change from Baseline Blood pressure (mmHg) at 3 months and 6 months

triglyceride

时间窗: 6 months

Change from Baseline triglyceride (mg/dl) at 3 months and 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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