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Exploring the Effects of a Baduanjin Program on the Symptoms of Constipation in Patients With Schizophrenia Spectrum

Primary Purpose

Randomized Controlled Trial

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Baduanjin program
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Randomized Controlled Trial focused on measuring Baduanjin program, constipation, intestinal peristalsis, schizophrenia spectrum

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Baduanjin program

Control group

Arm Description

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.

The control group (CG) received routine care.

Outcomes

Primary Outcome Measures

Changes in Intestinal Peristalsis
Change from Baseline bowel movement of four quadrants of abdomen at 3 months and 6 months

Secondary Outcome Measures

Changes in Constipation Assessment Scale
Change from Baseline Constipation Assessment Scale at 3 months and 6 months. The nine symptoms evaluated included: bloating, increased gas delivery in the rectum, decreased / increase frequency of bowel movements, oozing water, rectal obstruction or pressure, bowel movements combined with rectal pain, low bowel movements, and inability to defecate. 3 points scoring method (0-2), 0 is no problem, 1 is a bit problem, 2 is a serious problem. The maximum total score is 18.
Change in Patient Assessment of Constipation Symptoms
Change from Baseline Patient Assessment of Constipation Symptoms at 3 months and 6 months. The 12 items are divided into 3 subscales: 4 items for abdominal symptoms, 3 items for rectal symptoms, and 5 items for fecal symptoms. Patient Assessment of Constipation Symptoms Scale items are rated on a 5-point scale ranging from 0 to 4 based on severity of each item. The maximum total score is 48.

Full Information

First Posted
August 25, 2019
Last Updated
September 7, 2020
Sponsor
National Yang Ming University
Collaborators
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04071444
Brief Title
Exploring the Effects of a Baduanjin Program on the Symptoms of Constipation in Patients With Schizophrenia Spectrum
Official Title
Exploring the Predictors of Constipation and the Effects of a Baduanjin Program on the Symptoms of Constipation in Adults With Chronic Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Randomized Controlled Trial
Keywords
Baduanjin program, constipation, intestinal peristalsis, schizophrenia spectrum

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were divided into experimental and control groups through block randomization.
Masking
Participant
Masking Description
The data of Intestinal Peristalsis in four quadrants were collected by a research assistant.
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group (CG) received routine care.
Intervention Type
Other
Intervention Name(s)
Baduanjin program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Intestinal Peristalsis
Description
Change from Baseline bowel movement of four quadrants of abdomen at 3 months and 6 months
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
Changes in Constipation Assessment Scale
Description
Change from Baseline Constipation Assessment Scale at 3 months and 6 months. The nine symptoms evaluated included: bloating, increased gas delivery in the rectum, decreased / increase frequency of bowel movements, oozing water, rectal obstruction or pressure, bowel movements combined with rectal pain, low bowel movements, and inability to defecate. 3 points scoring method (0-2), 0 is no problem, 1 is a bit problem, 2 is a serious problem. The maximum total score is 18.
Time Frame
3 months and 6 months
Title
Change in Patient Assessment of Constipation Symptoms
Description
Change from Baseline Patient Assessment of Constipation Symptoms at 3 months and 6 months. The 12 items are divided into 3 subscales: 4 items for abdominal symptoms, 3 items for rectal symptoms, and 5 items for fecal symptoms. Patient Assessment of Constipation Symptoms Scale items are rated on a 5-point scale ranging from 0 to 4 based on severity of each item. The maximum total score is 48.
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Yueh Yang, PhD
Organizational Affiliation
Yang Ming National University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li-Ru Wang, MSN
Organizational Affiliation
National Yang Ming University
Official's Role
Study Director
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

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Exploring the Effects of a Baduanjin Program on the Symptoms of Constipation in Patients With Schizophrenia Spectrum

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