The Impacts of Yoga and Aerobic Exercise on Neuro-cognitive Function and Symptoms in Early Psychosis - A Single-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Working Memory
研究概览
简要总结
The current study aims to evaluate the impacts of yoga and aerobic exercise on neuro-cognitive function, symptoms and brain changes in early psychosis. A total of 120 female subjects who aging from 18-55 years old, and diagnosed with psychotic disorders within the past 5 years, will be randomized into 3 groups: 1) yoga therapy, 2) aerobic exercise, and 3) waitlist group as the control. All groups will try to be kept consistent with their medication with no more than 25% change in their entry level dosage for at least six weeks. The primary outcomes of the present study will be neuro-cognitive changes; the secondary outcomes will be changes of brain structure and function.
详细描述
STUDY OBJECTIVES AND PURPOSE
The present study aims to:
- Compare the effects of a 12-week integrated yoga therapy and 12-week aerobic exercise program (walking and cycling) on cognitive functions, brain structures and function in female psychosis patients.
- Compare the changes in physical fitness, clinical symptoms, body-perception, drug adherence, quality of life, and medicational side-effects.
Descriptive data acquired from this study will contribute to a better understanding of the research implications and clinical applications of yoga and aerobic exercise.
SUBJECTS This is a single-blinded, randomized, prospective study using psychopathological assessments, self-rating scales and imaging techniques. In this study, only female psychosis patients will be recruited from the Early Assessment Service for Young People with Psychosis Program (EASY) in Hong Kong, aiming to examine if there is any gender difference in comparison to the study by Pajonk et al. (2007), which selected only male subjects.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged from 18 to
- •Based on the Diagnostic and Statistical Manual (DSM-IV) diagnosed to have schizophrenia, schizoaffective disorder, schizophreniform Psychosis, brief psychotic disorders, psychosis not otherwise specified and delusional disorder. Duration of illness is less than 5 years (including 5 years).
- •Cantonese-speaking Chinese.
- •Ability to understand the nature of the study and to give an informed consent.
- •Fewer than 10 hours of yoga and vigorous aerobic exercise (equivalent to jogging at 10 km/hr) in the previous 3 months.
排除标准
- •Severe physical illness (myocardial infarction, hypertension, fracture, spinal problem), seizure disorders, mental retardation or comorbid substance dependence. Heart rate and blood pressure will be measured at the baseline to exclude the patients with abnormal cardiovascular activities.
- •Unstable psychotic symptoms.
- •Known pregnancy, or other contraindication to MRI.
- •A history of brain trauma or organic brain disease.
- •Known history of intellectual disability or special school attendance.
研究组 & 干预措施
Yoga therapy
Hatha yoga including breathing control (10 minutes), body posture(40-45minutes), and relaxation (5 minutes).
干预措施: Yoga therapy (Behavioral)
Aerobic exercise
Aerobic exercise includes walking on the treadmill for 15-20 minutes and stationary cycling for 25-30 minutes.
干预措施: Aerobic exercise (Behavioral)
Waitlist group
Patients in waiting list will be treated as usual and acted as control group.
结局指标
主要结局
Working Memory
时间窗: baseline and 12 weeks
measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.
Attention and Concentration
时间窗: baseline and 12 weeks
measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter "C" and "E" as quickly as possible. The time to completion, number of error and omission items were recorded. A "quality of search" index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome).
Verbal Retention
时间窗: baseline and 12 weeks
The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.
Verbal Acquisition
时间窗: baseline and 12 weeks
Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.
次要结局
- Severity of Symptoms(Baseline and 12 weeks)
研究者
Eric Y H Chen
Professor, Head
The University of Hong Kong