The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change scores of 6-minute walk test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of schizophrenia according to the DSM-
- •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.
排除标准
- •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.
结局指标
主要结局
Change scores of 6-minute walk test
时间窗: Baseline, immediate after treatment, 4-week follow up
This test evaluates cardiovascular fitness and walking speed.
Change scores of 30-second chair stand test
时间窗: Baseline, immediate after treatment, 4-week follow up
This test evaluates muscular endurance of lower-extremities.
Change scores of Montreal cognitive assessment
时间窗: Baseline, immediate after treatment, 4-week follow up
This test evaluates global cognition.
Change scores of Timed up-and-go test
时间窗: Baseline, immediate after treatment, 4-week follow up
This test evaluates functional mobility, agility and balance
Change scores of Logical Memory
时间窗: Baseline, immediate after treatment, 4-week follow up
It is a subtest of the Wechsler Memory Scale. This test evaluates memory.
Change scores of Trail making test (part A and part B)
时间窗: Baseline, immediate after treatment, 4-week follow up
This test evaluates speed of processing, visual attention and cognitive flexibility.
次要结局
- Change scores of dual task Timed up-and-go test (cognitive)(Baseline, immediate after treatment, 4-week follow up)
- Change scores of Activities of Daily Living Rating Scale III(Baseline, immediate after treatment, 4-week follow up)
- Change scores of dual task Timed up-and-go test (manual)(Baseline, immediate after treatment, 4-week follow up)