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

Randomized Controlled Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069988
• Other study ID #: TSGHIRB2-105-05-005
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: July 2019
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Randomized Controlled Trial
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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