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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069988
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by (Responsible Party):
National Yang Ming 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.


Condition or disease Intervention/treatment Phase
Randomized Controlled Trial Behavioral: Baduanjin program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants were divided into experimental and control groups through block randomization.
Masking: Single (Participant)
Masking Description: The data of the five metabolic indexes, height, and bodyweight were collected by a research assistant.
Primary Purpose: Other
Official Title: Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia: A Randomized Controlled Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
No Intervention: Control group
The control group (CG) received routine care and was required to physical activity for thirty minutes
Experimental: 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.
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.




Primary Outcome Measures :
  1. body Mass Index [ Time Frame: 6 months ]
    BMI is defined as Body weight(kilograms) divided by height (meter) squared

  2. Fasting blood sugar [ Time Frame: 6 months ]
    Change from Baseline Fasting blood sugar (mg/dl) at 3 months and 6 months

  3. Waist circumference [ Time Frame: 6 months ]
    Change from Baseline Waist circumference (inches) at 3 months and 6 months

  4. triglyceride [ Time Frame: 6 months ]
    Change from Baseline triglyceride (mg/dl) at 3 months and 6 months

  5. Blood pressure [ Time Frame: 6 months ]
    Change from Baseline Blood pressure (mmHg) at 3 months and 6 months

  6. high-density lipoprotein [ Time Frame: 6 months ]
    Change from Baseline high-density lipoprotein (mg/dl) at 3 months and 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069988


Locations
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Taiwan
National Yang-Ming University
Taipei City, Taiwan
Sponsors and Collaborators
National Yang Ming University
Tri-Service General Hospital
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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT04069988    
Other Study ID Numbers: TSGHIRB2-105-05-005
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Yang Ming University:
Baduanjin
body mass index
metabolic parameters
metabolic syndrome
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders