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Completed

NCT Number: NCT04069988

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

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.

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Key information

Conditions

Randomized Controlled Trial Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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