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

Not Applicable

Completed

• Conditions: Randomized Controlled Trial
• Interventions: Behavioral: Baduanjin program

• Registration Number: NCT04069988
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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.

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 Timeline

• Study Start: 2016-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2019-07
• Study First Submitted: 2019-08-25
• Study First Submitted QC: 2019-08-25
• Last Update Submitted: 2019-08-25
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baduanjin program	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei City, Taiwan