Aerobic Exercise for Cognition in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
研究概览
简要总结
This study will evaluate the ability of aerobic exercise (AE) to improve cognition in people with schizophrenia. Participants will be randomly assigned to one of two interventions: (1) aerobic exercise class (stationary bicycle, or "spin" class) for up to 45 minutes three times per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times per week for 12 weeks.
详细描述
Schizophrenia (SCZ) is a severe, chronic, and disabling psychotic illness that affects approximately 87,000 Veterans. Previous studies have reported improved short-term memory with AE, but there in a lack of information on cognitive effects of AE in SCZ. The investigators want to determine if twelve weeks of AE training improves cognitive function in Veterans with SCZ.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder
- •maintained on stable doses of outpatient psychiatric medications for at least 30 days
- •compliant with outpatient follow-up
- •have a stable place to live
- •access to transportation to the hospital
- •doing less than 20 minutes per week of regular physical activity in the past month
排除标准
- •Bipolar disorder;
- •active substance dependence within the prior 30 days
- •more than 2 psychiatric admissions within the prior six months
- •known HIV infection or AIDS
- •history of traumatic brain injury
- •current seizure disorder
- •Alzheimer's disease or other dementia
- •clinical history of mild cognitive impairment
- •Parkinson's disease
- •other current clinically significant neurological disease
- •unstable medical condition that would be expected to interfere with fitness training
- •significant hearing or visual impairment
研究组 & 干预措施
Aerobic Exercise
Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
干预措施: Aerobic Exercise (Behavioral)
Balance and Stretching
Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
干预措施: Balance and Stretching (Behavioral)
结局指标
主要结局
Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
时间窗: Baseline, 12 weeks
Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.
次要结局
- Change in Functional Ability(Baseline, 12 weeks)
- Change in MCCB Scores(Baseline, 20 weeks)
- Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)(Baseline, 20 weeks)