Clinical trial NCT04069988: 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
Overall status: COMPLETED
Phase: NA
Conditions: Randomized Controlled Trial
Keywords: Baduanjin
body mass index
metabolic parameters
metabolic syndrome
schizophrenia
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2019-08-28
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were divided into experimental and control groups through block randomization.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: body Mass Index
timeFrame: 6 months
measure: Fasting blood sugar
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
measure: triglyceride
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: high-density lipoprotein
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Yang-Ming University
Study officials:
References: