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临床试验/NCT04027634
NCT04027634已完成不适用

Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia: A Pilot Randomized Controlled Trial

National Yang Ming Chiao Tung University0 个研究点目标入组 22 人开始时间: 2014年9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
22
主要终点
Body weight

研究概览

简要总结

Introduction Low levels of physical activity and central obesity contribute to metabolic syndrome in patients with schizophrenia.

Aim This study was to examine the effectiveness of Baduanjin program on body mass index (BMI) and five metabolic parameters in participants with chronic schizophrenia.

Methods A randomized controlled trial was conducted in a psychiatric center in northern Taiwan. The eligibility criteria included BMI > 25 kg/m2, or with metabolic syndrome. Twenty-two participants were randomized to two groups using blocked randomization. The experimental group was provided with an 8-session Baduanjin program for 12 weeks (1 h, thrice times per week), while the control group received routine care.

详细描述

This study was conducted in a large psychiatric center that has 10 residential rehabilitation units. Residents were allowed to walk for 20 min during 6-7 pm every day, and each unit could accommodate approximately 50 residents. In this study, patients on the schizophrenia spectrum were invited to receive screening for metabolic syndrome. A total of 108 patients agreed to undergo the screening, and forty-seven patients were confirmed to have metabolic syndrome. Patients with metabolic syndrome or BMIs > 25 kg/m2 were invited to participate in the research. In total, sixty-two patients satisfied the inclusion criteria, and 22 patients consented to participate in the experiment.

Each participant was assigned one number from 1 to 22 by the first author. The second author enrolled participants. They were randomized to either Baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 4 by the fourth author. Patients in the experimental group (EG) participated in the Baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 h after dinner between 6 and 7 pm; the entire program continued for 12 weeks. The control group (CG) received routine care and was required to walk during 6-7 pm. The outcome indicators for this intervention program involved the risk factors for metabolic syndrome, BW, and BMI.

When schizophrenia becomes chronic, patients experience lack of motivation. This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program. While these participants practiced the Baduanjin program, the CG participants walked for 15-20 min in their wards.

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 BW 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

  • People were diagnosed with schizophrenia at the age of 20-65 years.
  • People had taken regular antipsychotic medication for more than 10 weeks
  • People lacked regular exercise in the past 3 months.
  • People consented to receive blood collection and complete a questionnaire.
  • People satisfied the modified Adult Treatment Panel III criteria for Asians i.e., three abnormal results for metabolic syndrome or two abnormal results with BMI > 25)

排除标准

  • People with organic mental disorders, alcohol dependence, and substance abuse.
  • people who are not willing to sign the consent.

研究组 & 干预措施

Control group

No Intervention

The control group (CG) received routine care and was required to walk during 6-7 pm.

Baduanjin program

Experimental

The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program.

干预措施: Baduanjin program (Other)

结局指标

主要结局

Body weight

时间窗: 3 months

Change from Baseline Body weight (kilograms) at 3 months

body Mass Index (BMI).

时间窗: 3 months

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

次要结局

  • Fasting blood sugar(3 months)
  • Waist circumference(3 months)
  • triglyceride(3 months)
  • high-density lipoprotein(3 months)
  • Blood pressure(3 months)

研究者

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

Chiu-Yueh Yang

Associate Professor

National Yang Ming Chiao Tung University

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