Clinical trial NCT04071444: 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
Overall status: COMPLETED
Phase: NA
Conditions: Randomized Controlled Trial
Keywords: Baduanjin program
constipation
intestinal peristalsis
schizophrenia spectrum
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2019-08-28
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were divided into experimental and control groups through block randomization.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in Intestinal Peristalsis
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Changes in Constipation Assessment Scale
timeFrame: 3 months and 6 months
measure: Change in Patient Assessment of Constipation Symptoms
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: Yang Ming National University
name: Chiu-Yueh Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Yang Ming Chiao Tung University
name: Li-Ru Wang, MSN
role: STUDY_DIRECTOR
References: