The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from Baseline in Daily Functioning Assessments at 12 weeks
研究概览
简要总结
The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and neurocognitive functioning including memory, attention, the ability to plan activities, and learn new information. Participants will be assigned by chance to receive regular care or exercise sessions in addition to regular care. This study will allow determining the potential positive influence of AE on cognitive and daily functioning in individuals with schizophrenia.
详细描述
Individuals with schizophrenia often display cognitive difficulties. Studies among non-clinical populations suggest that Aerobic Exercise (AE) training is effective in increasing both aerobic fitness and cognitive functioning. However, these associations have not been studied among individuals with schizophrenia, despite the presence of highly sedentary lifestyle in this population To elucidate this putative link, the present study will evaluate the influence of AE on cognitive functioning and daily functioning in individuals with schizophrenia using a single-blind, randomized clinical trial. Outpatient individuals with schizophrenia receiving treatment will be randomly assigned to AE training or Treatment As Usual (TAU). Participants in the AE training will undergo a 12-week, 3 times per week, 1-hour AE sessions. All participants will continue their regular psychiatric and medical care. Assessments of neurocognitive and daily functioning abilities, along with symptom severity, and physiological and behavioral measures of aerobic fitness will be completed before and after the 12-week program.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between ages 18-
- •Have capacity to give informed consent.
- •English speaking.
- •Have a DSM-IV diagnosis of schizophrenia.
- •Taking antipsychotic medication for at least 8 weeks and on current doses for 4 weeks, and/or injectable depot antipsychotics with no change in last 3 months.
- •Medically cleared to exercise.
排除标准
- •Lacks capacity to give informed consent.
- •Have used street drugs within the past 4 weeks.
- •Have history of of hypertension of cardiac conditions.
- •Have history of active suicidal ideation or serious self-destructive behavior.
- •Have history of violence or aggressive behavior.
- •Have history of neurological or medical conditions known to seriously affect the brain.
- •Pregnant or nursing.
- •Completing more than 2 hours of moderate or higher levels of aerobic exercise per week.
- •Participation in a study of cognition during the previous 2 months.
结局指标
主要结局
Change from Baseline in Daily Functioning Assessments at 12 weeks
时间窗: Baseline and after 12 weeks
Measures include: The Specific Levels of Functioning Scale (SLOF), Quality of Life Scale (QLS), and Quality of Life Scale (QoL-16).
Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks
时间窗: Baseline and after 12 weeks
The VO2Max (maximal oxygen consumption) test measures maximum ability to consume oxygen and is a key indicator of aerobic fitness.
Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks
时间窗: Baseline and after 12 weeks.
Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks
时间窗: Baseline and after 12 weeks
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
次要结局
- Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks(Baseline and after 12 weeks)