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

Primary Purpose

Randomized Controlled Trial

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baduanjin program
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Randomized Controlled Trial focused on measuring Baduanjin program, body mass index, metabolic parameters, schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Baduanjin program

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 13, 2019
    Last Updated
    July 18, 2019
    Sponsor
    National Yang Ming University
    Collaborators
    Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04027634
    Brief Title
    Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia
    Official Title
    Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia: A Pilot Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Yang Ming University
    Collaborators
    Taipei Veterans General Hospital, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Randomized Controlled Trial
    Keywords
    Baduanjin program, body mass index, metabolic parameters, schizophrenia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants were divided into experimental and control groups through block randomization.
    Masking
    Participant
    Masking Description
    The data of the five metabolic indexes, height, and BW were collected by a research assistant.
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group (CG) received routine care and was required to walk during 6-7 pm.
    Arm Title
    Baduanjin program
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Baduanjin program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body weight
    Description
    Change from Baseline Body weight (kilograms) at 3 months
    Time Frame
    3 months
    Title
    body Mass Index (BMI).
    Description
    BMI is defined as Body weight(kilograms) divided by height (meter) squared
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Fasting blood sugar
    Description
    Change from Baseline Fasting blood sugar (mg/dl) at 3 months
    Time Frame
    3 months
    Title
    Waist circumference
    Description
    Change from Baseline Waist circumference (inches) at 3 months
    Time Frame
    3 months
    Title
    triglyceride
    Description
    Change from Baseline triglyceride (mg/dl) at 3 months
    Time Frame
    3 months
    Title
    Blood pressure
    Description
    Change from Baseline Blood pressure (mmHg) at 3 months
    Time Frame
    3 months
    Title
    high-density lipoprotein
    Description
    Change from Baseline high-density lipoprotein (mg/dl) at 3 months
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chiu-Yueh Yang
    Organizational Affiliation
    ICMJE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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