Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia

Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia: A Randomized Controlled Trial

Baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia.

Aim This study was to explore the effect of Baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia.

Methods We recruited 92 participants from 3 chronic wards and nursing homes in eastern and northern Taiwan. Participants were assigned by blocked randomization into experimental group and control group. Those in the experimental group received 60 minutes, three times a week for 12 weeks of Baduanjin program training, while those in the control group received physical activity for thirty minutes. We collected the blood pressure, fasting blood sugar, triglyceride, high density cholesterol, waist circumference, and body mass index three times: before the intervention, end of the intervention immediately and 3-month follow up. Chi-squared and independent samples t test were used to compare the groups differences in the demographic characteristics and outcome indicators at the baseline for male and female separately. Demographic variables were controlled. Generalized Estimating Equations (GEE) were used to examine the effects of groups, time, group and time interaction by sex.

Study Overview

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

Detailed Description

This study explored the effect of Baduanjin on metabolic parameters and body mass index in people with schizophrenia. We recruited 92 participants from 3 rehabilitation units in Taiwan. Participants were assigned by blocked randomization into an experimental group or control group. Those in the experimental group received 60 minutes of Baduanjin three times a week for 12-weeks, while those in the control group received physical activity for thirty minutes. We assessed five metabolic parameters and body mass index at three timepoints: baseline, posttest and 3-month follow up.

• Study Type: Interventional
• Enrollment (Actual): 92
• 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 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. diagnosis of schizophrenia
2. between 20-65 years of age
3. BMI ≥ 24 kg/m2 or at least one metabolic parameter abnormality
4. ability to listen, speak and write Chinese
5. no additional exercise beyond normal exercise.

Exclusion Criteria:

1. patients in acute phase requiring hospitalization;
2. patients with severe and unstable

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
No Intervention: Control group; The control group (CG) received routine care and was required to physical activity for thirty minutes
Experimental: Baduanjin program; The entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks ; 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.	Behavioral: Baduanjin program; This exercise program aimed to increase patient participation and control their metabolic parameters and body mass index through Baduanjin program. The entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks; 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 warmup, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body Mass Index	BMI is defined as Body weight(kilograms) divided by height (meter) squared	6 months
Fasting blood sugar	Change from Baseline Fasting blood sugar (mg/dl) at 3 months and 6 months	6 months
Waist circumference	Change from Baseline Waist circumference (inches) at 3 months and 6 months	6 months
triglyceride	Change from Baseline triglyceride (mg/dl) at 3 months and 6 months	6 months
Blood pressure	Change from Baseline Blood pressure (mmHg) at 3 months and 6 months	6 months
high-density lipoprotein	Change from Baseline high-density lipoprotein (mg/dl) at 3 months and 6 months	6 months

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: body mass index; schizophrenia; metabolic syndrome; metabolic parameters; Baduanjin
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: TSGHIRB2-105-05-005

Drug and device information, study documents

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