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

NCT ID: NCT04069988

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-10-31

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.

Conditions

Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Baduanjin program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Yang-Ming University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TSGHIRB2-105-05-005

Identifier Type: -

Identifier Source: org_study_id