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

NCT04027634 | Completed DMC

• 1 other identifier: JIRB12-S-019
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Randomized Controlled Trial

Keywords

Baduanjin program; body mass index; metabolic parameters; schizophrenia

Outcome Measures

Primary Outcomes (2)

• Body weight

  Change from Baseline Body weight (kilograms) at 3 months

  3 months

• body Mass Index (BMI).

  BMI is defined as Body weight(kilograms) divided by height (meter) squared

  3 months

Secondary Outcomes (5)

• Fasting blood sugar

  3 months

• Waist circumference

  3 months

• triglyceride

  3 months

• Blood pressure

  3 months

• high-density lipoprotein

  3 months

Study Arms (2)

Control group

NO INTERVENTION

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

Baduanjin program

EXPERIMENTAL

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

Interventions

Baduanjin program OTHER

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.

Baduanjin program

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• People with organic mental disorders, alcohol dependence, and substance abuse.
• people who are not willing to sign the consent.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Chiu-Yueh Yang

  ICMJE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The data of the five metabolic indexes, height, and BW were collected by a research assistant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants were divided into experimental and control groups through block randomization.

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 22, 2019
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 22, 2019

Record last verified: 2019-07