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

Primary Purpose

Randomized Controlled Trial

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Baduanjin program
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Randomized Controlled Trial focused on measuring Baduanjin, body mass index, metabolic parameters, metabolic syndrome, schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Baduanjin program

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2019
Last Updated
August 25, 2019
Sponsor
National Yang Ming University
Collaborators
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04069988
Brief Title
Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia
Official Title
Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Randomized Controlled Trial
Keywords
Baduanjin, body mass index, metabolic parameters, metabolic syndrome, schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were divided into experimental and control groups through block randomization.
Masking
Participant
Masking Description
The data of the five metabolic indexes, height, and bodyweight were collected by a research assistant.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group (CG) received routine care and was required to physical activity for thirty minutes
Arm Title
Baduanjin program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin program
Intervention Description
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.
Primary Outcome Measure Information:
Title
body Mass Index
Description
BMI is defined as Body weight(kilograms) divided by height (meter) squared
Time Frame
6 months
Title
Fasting blood sugar
Description
Change from Baseline Fasting blood sugar (mg/dl) at 3 months and 6 months
Time Frame
6 months
Title
Waist circumference
Description
Change from Baseline Waist circumference (inches) at 3 months and 6 months
Time Frame
6 months
Title
triglyceride
Description
Change from Baseline triglyceride (mg/dl) at 3 months and 6 months
Time Frame
6 months
Title
Blood pressure
Description
Change from Baseline Blood pressure (mmHg) at 3 months and 6 months
Time Frame
6 months
Title
high-density lipoprotein
Description
Change from Baseline high-density lipoprotein (mg/dl) at 3 months and 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: patients in acute phase requiring hospitalization; patients with severe and unstable
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

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

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