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

Sponsor

National Yang Ming University (Other)

Overall Status

Completed

CT.gov ID

NCT04027634

Collaborator

Taipei Veterans General Hospital, Taiwan (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Randomized Controlled Trial	Other: Baduanjin program	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The participants were divided into experimental and control groups through block randomization.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 BW were collected by a research assistant.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group The control group (CG) received routine care and was required to walk during 6-7 pm.
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: Control group

The control group (CG) received routine care and was required to walk during 6-7 pm.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Body weight [3 months]
Change from Baseline Body weight (kilograms) at 3 months
body Mass Index (BMI). [3 months]
BMI is defined as Body weight(kilograms) divided by height (meter) squared

Secondary Outcome Measures

Fasting blood sugar [3 months]
Change from Baseline Fasting blood sugar (mg/dl) at 3 months
Waist circumference [3 months]
Change from Baseline Waist circumference (inches) at 3 months
triglyceride [3 months]
Change from Baseline triglyceride (mg/dl) at 3 months
Blood pressure [3 months]
Change from Baseline Blood pressure (mmHg) at 3 months
high-density lipoprotein [3 months]
Change from Baseline high-density lipoprotein (mg/dl) at 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Yang Ming University
Taipei Veterans General Hospital, Taiwan

Investigators

Principal Investigator: Chiu-Yueh Yang, ICMJE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chiu-Yueh Yang, Associate Professor, National Yang Ming University

ClinicalTrials.gov Identifier:

NCT04027634

Other Study ID Numbers:

JIRB12-S-019

First Posted:

Jul 22, 2019

Last Update Posted:

Jul 22, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chiu-Yueh Yang, Associate Professor, National Yang Ming University

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Jul 22, 2019