- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06226779
Baduanjin Versus Brisk Walking for Cognition in Schizophrenia
Mindful Exercise Baduanjin Versus Brisk Walking for Cognitive Function in Patients With Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cognitive function deficits are core features in patients with schizophrenia. These deficits need active intervention to prevent functional decline. Baduanjin and brisk walking show promise as interventions in patients with schizophrenia. This study investigated the effects of Baduanjin exercise versus brisk walking in patients with schizophrenia.
This study will be a single-blind, 3-arm, parallel, randomized controlled trial.
A total of 72 patients with schizophrenia will be enrolled and randomly assigned to the Baduanjin group, brisk walking group or control group. The intervention group will practice Badunjin exercise. While participants in brisk walking group will receive brisk walking at the same duration. The controls will watch videos that are not aimed at improving physical exertion. Maintenance programs will also be conducted for participants to encourage practicing in exercise after intervention. All group will undergo evaluation at three time points: baseline, immediately after intervention and 4-week follow up after intervention. The primary outcome will be cognitive function and physical function. Secondary outcomes will include mood, sleep quality, and quality of live.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaohsiung, Taiwan, 833
- Chang Gung Memorial Hospital, Kaohsiung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a diagnosis of schizophrenia according to the DSM-5.
- Who will be above 20-65 years of age .
- Having a stable mental status without shift in medication and keep in same dose for at least one month.
- Being able to walk independently for 50 meters.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Baduanjin
Parcipants will practice baduanjin exercise.
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The Baduanjin exercise consists of 8 postures, with emphasis on different body parts.
The exercise is commonly practiced as follows: (1) 2 hands holding up the heavens, (2) drawing the bow to shoot the eagle, (3) separating the heaven and earth, (4) wise owl gazing backwards, (5) swaying the head and shaking the tail, (6) 2 hands holding the feet to strengthen the waist, (7) clenching the fists and glaring fiercely, and (8) bouncing on the toes.
Other Names:
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Active Comparator: Brisk walking
Parcipants will perform brisk walking activities.
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The brisk walking will be gradually increased physical exertion from light to moderate of intensity.
During the training period, the heart rate of participants will be monitored.
Other Names:
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Other: health education
Parcipants will receive health education classes and watch sport related videos.
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Health education will include lecture classes.
Video watching will watch videos which were not aim at improving physical exertion, such as sports games or sports related variety shows
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change scores of 6-minute walk test
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates cardiovascular fitness and walking speed.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of 30-second chair stand test
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates muscular endurance of lower-extremities.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of Timed up-and-go test
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates functional mobility, agility and balance
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Baseline, immediate after treatment, 4-week follow up
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Change scores of dual task Timed up-and-go test (manual)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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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.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of dual task Timed up-and-go test (cognitive)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test combine serial three counting and Timed up-and-go test simultaneously.
It evaluates dual task performance.
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Baseline, immediate after treatment, 4-week follow up
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Change score of the Brief Assessment of Cognition in Schizophrenia (BACS)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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BACS is a battery of cognition tests that measure verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function.The BACS is comprised of seven subtests: (1) the List Learning Test, (2) Digit Sequencing Test, (3) Token Motor Test, (4) Category Instance Test, (5) Controlled Oral Word Association Test, (6) Symbol Coding, and (7) Tower of London Test.
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Baseline, immediate after treatment, 4-week follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change score of Depression, Anxiety Stress Scales-21 (DASS-21)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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DASS-21 is a self-report questionnaire that measure symptoms of depression, anxiety, and stress.
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Baseline, immediate after treatment, 4-week follow up
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Change score of Pittsburg Sleep Quality Index
Time Frame: Baseline, immediate after treatment, 4-week follow up
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PSQI is a self-report assessment which contains 19 items to measure sleep quality
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Baseline, immediate after treatment, 4-week follow up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chen Chyi-Rong, Master, Chang Gung Memorial Hospital, Kaohsiung Branch
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202400006B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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