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

NCT04071444 | Completed

• 1 other identifier: 2-107-05-114
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Randomized Controlled Trial

Keywords

Baduanjin program; constipation; intestinal peristalsis; schizophrenia spectrum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Constipation Assessment Scale

  3 months and 6 months

• Change in Patient Assessment of Constipation Symptoms

  3 months and 6 months

Study Arms (2)

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.

Other: Baduanjin program

Control group

NO INTERVENTION

The control group (CG) received routine care.

Interventions

Baduanjin program OTHER

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.

Baduanjin program

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

National Yang-Ming University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chiu-Yueh Yang, PhD

  Yang Ming National University

  PRINCIPAL INVESTIGATOR

• Li-Ru Wang, MSN

  National Yang Ming Chiao Tung University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The data of Intestinal Peristalsis in four quadrants were collected by a research assistant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants were divided into experimental and control groups through block randomization.

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: October 8, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 9, 2020

Record last verified: 2018-03

Locations

TW (1)