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Baduanjin on Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Baduanjin exercise program
Brisk walking program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, mind body intervention ,Baduanjin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having a diagnosis of schizophrenia according to the DSM-5.
  • Independent adult aged 40 years or older in the day-care center.
  • Having a stable mental status without shift in medication and keep in same dose for at least one month.

Exclusion Criteria:

  • Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.
  • Visual or auditory impairment that precludes completion of assessment.
  • Acute psychosis requiring hospitalization.
  • Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.
  • Participating in another clinical trial at the same time.

Sites / Locations

  • Chang Gung Memorial Hospital, Kaohsiung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baduanjin exercise group

Control group

Arm Description

The intervention group will practice Badunjin in a group which include 6-8 participants and one trained medical staff. The Baduanjin is an ancient Chinese mind-body exercise, which comprised of eight simple movements. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks

The control group will receive brisk walking activities. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks

Outcomes

Primary Outcome Measures

Change scores of 6-minute walk test
This test evaluates cardiovascular fitness and walking speed.
Change scores of 30-second chair stand test
This test evaluates muscular endurance of lower-extremities.
Change scores of Timed up-and-go test
This test evaluates functional mobility, agility and balance
Change scores of Montreal cognitive assessment
This test evaluates global cognition.
Change scores of Trail making test (part A and part B)
This test evaluates speed of processing, visual attention and cognitive flexibility.
Change scores of Logical Memory
It is a subtest of the Wechsler Memory Scale. This test evaluates memory.

Secondary Outcome Measures

Change scores of dual task Timed up-and-go test (manual)
This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance.
Change scores of dual task Timed up-and-go test (cognitive)
This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.
Change scores of Activities of Daily Living Rating Scale III
It is a self-administered, paper-and-pencil test that evaluates daily functions

Full Information

First Posted
June 3, 2020
Last Updated
July 28, 2021
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Taiwan University
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1. Study Identification

Unique Protocol Identification Number
NCT04430309
Brief Title
Baduanjin on Patients With Schizophrenia
Official Title
The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Taiwan University

4. Oversight

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

5. Study Description

Brief Summary
As an ancient, popular Chinese exercise, Baduanjin is characterized by symmetrical posture, deep breathing and meditation and easy to learn. Previous studies showed immediate effect of Baduanjin on cognition in patients with schizophrenia.The purpose of this study is to investigate the immediate effect and chronic effect of Baduanjin exercise on physical fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.
Detailed Description
A single-blind, 2-arm randomized controlled trial investigating the benefits of Baduanjin exercise on middle-aged and older patients with schizophrenia. A total of 48 participants will be assigned to either 12 weeks of 60-minute two sessions per week Baduanjin exercise group or a brisk walking group. Primary outcomes are physical fitness and cognition functions. Secondary outcomes are dual task performance and daily functions. Evaluation will be completed at baseline, immediately after treatment and 4-week follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, mind body intervention ,Baduanjin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin exercise group
Arm Type
Experimental
Arm Description
The intervention group will practice Badunjin in a group which include 6-8 participants and one trained medical staff. The Baduanjin is an ancient Chinese mind-body exercise, which comprised of eight simple movements. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive brisk walking activities. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin exercise program
Other Intervention Name(s)
Eight Silken Movements, Eight Silk Weaving
Intervention Description
The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
Intervention Type
Behavioral
Intervention Name(s)
Brisk walking program
Intervention Description
The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.
Primary Outcome Measure Information:
Title
Change scores of 6-minute walk test
Description
This test evaluates cardiovascular fitness and walking speed.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of 30-second chair stand test
Description
This test evaluates muscular endurance of lower-extremities.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of Timed up-and-go test
Description
This test evaluates functional mobility, agility and balance
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of Montreal cognitive assessment
Description
This test evaluates global cognition.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of Trail making test (part A and part B)
Description
This test evaluates speed of processing, visual attention and cognitive flexibility.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of Logical Memory
Description
It is a subtest of the Wechsler Memory Scale. This test evaluates memory.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Secondary Outcome Measure Information:
Title
Change scores of dual task Timed up-and-go test (manual)
Description
This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of dual task Timed up-and-go test (cognitive)
Description
This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.
Time Frame
Baseline, immediate after treatment, 4-week follow up
Title
Change scores of Activities of Daily Living Rating Scale III
Description
It is a self-administered, paper-and-pencil test that evaluates daily functions
Time Frame
Baseline, immediate after treatment, 4-week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a diagnosis of schizophrenia according to the DSM-5. Independent adult aged 40 years or older in the day-care center. Having a stable mental status without shift in medication and keep in same dose for at least one month. Exclusion Criteria: Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease. Visual or auditory impairment that precludes completion of assessment. Acute psychosis requiring hospitalization. Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions. Participating in another clinical trial at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chyi-Rong Chen, Master
Phone
+886-7-7317123
Ext
8755
Email
ccr776@cgmh.org.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Kaohsiung Medical Center
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chyi-Rong Chen
Phone
+886-7-7317123
Ext
8755
Email
ccr776@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Yee-Wen Lee
Phone
+886-7-7317123
Ext
8691
Email
hikare2000@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Baduanjin on Patients With Schizophrenia

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