Baduanjin on Patients With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Baduanjin exercise program
* Behavioral: Brisk walking program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baduanjin exercise group<br>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 | Behavioral: Baduanjin exercise program<br>* The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.<br>* Other names: Eight Silk Weaving;|
| Active Comparator: Control group<br>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 | Behavioral: Brisk walking program<br>* The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores of 6-minute walk test | This test evaluates cardiovascular fitness and walking speed. | Baseline, immediate after treatment, 4-week follow up | 
| Change scores of 30-second chair stand test | This test evaluates muscular endurance of lower-extremities. | Baseline, immediate after treatment, 4-week follow up | 
| Change scores of Timed up-and-go test | This test evaluates functional mobility, agility and balance | Baseline, immediate after treatment, 4-week follow up | 
| Change scores of Montreal cognitive assessment | This test evaluates global cognition. | Baseline, immediate after treatment, 4-week follow up | 
| Change scores of Trail making test (part A and part B) | This test evaluates speed of processing, visual attention and cognitive flexibility. | Baseline, immediate after treatment, 4-week follow up | 
| Change scores of Logical Memory | It is a subtest of the Wechsler Memory Scale. This test evaluates memory. | Baseline, immediate after treatment, 4-week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, immediate after treatment, 4-week follow up | 
| 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. | Baseline, immediate after treatment, 4-week follow up | 
| Change scores of Activities of Daily Living Rating Scale III | It is a self-administered, paper-and-pencil test that evaluates daily functions | Baseline, immediate after treatment, 4-week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, mind body intervention ,Baduanjin