Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia

Randomized Controlled Trial Clinical Trial

Official title:

Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027634
• Other study ID #: JIRB12-S-019
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2019
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction Low levels of physical activity and central obesity contribute to metabolic syndrome in patients with schizophrenia.

Aim This study was to examine the effectiveness of Baduanjin program on body mass index (BMI) and five metabolic parameters in participants with chronic schizophrenia.

Methods A randomized controlled trial was conducted in a psychiatric center in northern Taiwan. The eligibility criteria included BMI > 25 kg/m2, or with metabolic syndrome. Twenty-two participants were randomized to two groups using blocked randomization. The experimental group was provided with an 8-session Baduanjin program for 12 weeks (1 h, thrice times per week), while the control group received routine care.

Description:

This study was conducted in a large psychiatric center that has 10 residential rehabilitation units. Residents were allowed to walk for 20 min during 6−7 pm every day, and each unit could accommodate approximately 50 residents. In this study, patients on the schizophrenia spectrum were invited to receive screening for metabolic syndrome. A total of 108 patients agreed to undergo the screening, and forty-seven patients were confirmed to have metabolic syndrome. Patients with metabolic syndrome or BMIs > 25 kg/m2 were invited to participate in the research. In total, sixty-two patients satisfied the inclusion criteria, and 22 patients consented to participate in the experiment.

Each participant was assigned one number from 1 to 22 by the first author. The second author enrolled participants. They were randomized to either Baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 4 by the fourth author. Patients in the experimental group (EG) participated in the Baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 h after dinner between 6 and 7 pm; the entire program continued for 12 weeks. The control group (CG) received routine care and was required to walk during 6-7 pm. The outcome indicators for this intervention program involved the risk factors for metabolic syndrome, BW, and BMI.

When schizophrenia becomes chronic, patients experience lack of motivation. This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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. While these participants practiced the Baduanjin program, the CG participants walked for 15−20 min in their wards.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• People were diagnosed with schizophrenia at the age of 20-65 years.

• People had taken regular antipsychotic medication for more than 10 weeks

• People lacked regular exercise in the past 3 months.

• People consented to receive blood collection and complete a questionnaire.

• People satisfied the modified Adult Treatment Panel III criteria for Asians i.e., three abnormal results for metabolic syndrome or two abnormal results with BMI > 25)

Exclusion Criteria:

• People with organic mental disorders, alcohol dependence, and substance abuse.

• people who are not willing to sign the consent.

Related Conditions & MeSH terms

• Randomized Controlled Trial
• Schizophrenia

Intervention

Other:
• Baduanjin program
This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Change from Baseline Body weight (kilograms) at 3 months	3 months
Primary	body Mass Index (BMI).	BMI is defined as Body weight(kilograms) divided by height (meter) squared	3 months
Secondary	Fasting blood sugar	Change from Baseline Fasting blood sugar (mg/dl) at 3 months	3 months
Secondary	Waist circumference	Change from Baseline Waist circumference (inches) at 3 months	3 months
Secondary	triglyceride	Change from Baseline triglyceride (mg/dl) at 3 months	3 months
Secondary	Blood pressure	Change from Baseline Blood pressure (mmHg) at 3 months	3 months
Secondary	high-density lipoprotein	Change from Baseline high-density lipoprotein (mg/dl) at 3 months	3 months