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

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

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.

Study Overview

• Status: Completed
• Conditions: Randomized Controlled Trial
• Intervention / Treatment: Other: Baduanjin program

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baduanjin program; 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.	Other: Baduanjin program; 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.
No Intervention: Control group; The control group (CG) received routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intestinal Peristalsis	Change from Baseline bowel movement of four quadrants of abdomen at 3 months and 6 months	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months and 6 months
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.	3 months and 6 months

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Tri-Service General Hospital
• Investigators: Principal Investigator: Chiu-Yueh Yang, PhD, Yang Ming National University; Study Director: Li-Ru Wang, MSN, National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: August 25, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: constipation; Baduanjin program; schizophrenia spectrum; intestinal peristalsis
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Constipation
• Other Study ID Numbers: 2-107-05-114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No