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

NCT04069988 | Completed DMC

• 1 other identifier: TSGHIRB2-105-05-005
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Randomized Controlled Trial

Keywords

Baduanjin; body mass index; metabolic parameters; metabolic syndrome; schizophrenia

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Control group

NO INTERVENTION

The control group (CG) received routine care and was required to physical activity for thirty minutes

Baduanjin program

EXPERIMENTAL

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

Interventions

Baduanjin program BEHAVIORAL

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.

Baduanjin program

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients in acute phase requiring hospitalization;
• patients with severe and unstable

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

Metabolic Syndrome; Schizophrenia

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The data of the five metabolic indexes, height, and bodyweight 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: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 28, 2019

Record last verified: 2019-07

Locations

TW (1)