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临床试验/NCT04071444
NCT04071444已完成不适用

Exploring the Predictors of Constipation and the Effects of a Baduanjin Program on the Symptoms of Constipation in Adults With Chronic Schizophrenia

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年10月8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
入组人数
112
试验地点
1
主要终点
Changes in Intestinal Peristalsis

研究概览

简要总结

Patients with schizophrenia spectrum have been suffering from constipation due to long-term use of psychotropic medications and changes in physical activity and eating habits caused by diseases.

Aim this study was to examine the effectiveness of Baduanjin program in improving the symptoms of intestinal peristalsis and constipation in patients with psychosis.

Method:A randomized controlled trial was conducted in tow psychiatric centers in northern Taiwan.The experimental group was provided with an 8- session Baduanjin program for 24 weeks (1 hour, thrice times per week), while the control group received routine care.

详细描述

This study was conducted in two psychiatric center. Residents in one of psychiatric center were allowed to walk for 20 min after dinner every day, and each unit residents rare active. In this study, patients on the schizophrenia spectrum were invited to receive screening for constipation syndrome. A total of 275 patients agreed to undergo the screening. In total of 112 patients satisfied the inclusion criteria, and 58 patients consented to participate in the experiment.

Each participant was assigned one number from 1 to 112 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 3. 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 hour after dinner between 6 and 7 pm; the entire program continued for 24 weeks. The control group (CG) received routine care. The outcome indicators for this intervention program involved the risk factors for constipation, constipation symptoms, and Intestinal Peristalsis.

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 Intestinal Peristalsis in four quadrants were collected by a research assistant.

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Comply with the diagnosis of the spectrum.
  • •Have the willingness to participate in the study and could read, communicate and cooperate with the completion of the consent form and questionnaire.
  • •The age is 20 to 64 years old.
  • •No need for any assistance in walking, and the gait is stable.
  • •Appeared more than 2 times in the past month for more than 3 consecutive days without resolving or routine use of laxatives

排除标准

  • •Diagnosis is organic brain disease, alcohol and substance abuse.
  • •There have been problems with gastrointestinal bleeding or lesions.
  • •Have a history of extensive abdominal surgery or gastrointestinal surgery.
  • •There are medical considerations and medical expenses reduction activities.

研究组 & 干预措施

Baduanjin program

Experimental

The entire program continued for 6 months (December, 2018 to July, 2019), 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)

Control group

No Intervention

The control group (CG) received routine care.

结局指标

主要结局

Changes in Intestinal Peristalsis

时间窗: 3 months and 6 months

Change from Baseline bowel movement of four quadrants of abdomen at 3 months and 6 months

次要结局

  • Changes in Constipation Assessment Scale(3 months and 6 months)
  • Change in Patient Assessment of Constipation Symptoms(3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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