Aerobic Exercise for the Improvement of Cognition and Enhancement of Recovery in Post-acute Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- all-cause discontinuation
研究概览
简要总结
The study investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia.
详细描述
This multi-center, two-arm, parallel-group, randomized placebo-controlled add-on clinical trial investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia. The aim is the enhancement of recovery with the use of 26 weeks of continuos endurance training (aerobic exercise) with stationary bicycles or a balance and tone program consisting of exercises for flexibility, core strength, balance and relaxation. Followed by a follow-up period of 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent given by the subject; DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90); age 18 to 65 years, male or female; PANSS at baseline: total score ≤ 75, proper contraception in female patients of childbearing potential; treatment with one or two antipsychotics in a stable dose of at least two weeks, body mass index between 18 and 40.
排除标准
- •Lack of accountability; positive urine drug-screening for illicit drugs at screening (except benzodiazepines); serious suicidal risk at screening visit; other relevant interferences of axis 1 according to diagnostic evaluation (MINI); other relevant neurological or other medical disorders; pregnancy or lactation.
结局指标
主要结局
all-cause discontinuation
时间窗: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
Reason of study discontinuation will be identified. The all-cause-discontinuation questionnaire will be called up 9 times from baseline up to 12 months (compare time frame) including 26 weeks of intervention and 26 weeks follow up period. Reasons are defined as (1) relevant worsening of clinical symptoms (PANSS total score above 75 on cancerous visits for more than 14 days. (2) failure to take the prescribed medication for more than 14 days. (3) Failure to comply scheduled study or diagnostic appointments for more than 6 weeks (4) Patient unavailability despite extensive efforts of the treatment team (5) Withdrawal of patient consent (6) Clinician discontinuation.
次要结局
- improvement in neurocognition (VLMT)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in neurocognition (TMT)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in social and occupational functioning (PSP)(12 months (at baseline, day 98, day 182 and day 365))
- change of connectivity analysis (MRI of the brain)(12 months (at baseline, day 98, day 182 and day 365))
- change of volumes of brain regions (MRI)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in neurocognition (DSST)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in psychopathology (PANSS)(12 months (At baseline, day 98, 182 and day 365))
- improvement in neurocognition (MASC)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in psychopathology (CGI)(12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365))
- change of medication and attitude of the study participants to therapy (SES)(12 months (at baseline, day 98, day 182 and day 365))
- gene expression(baseline)
- change of genome-wide epigenetics(12 months (at baseline, day 98, day 182 and day 365))
- improvement in neurocognition (B-CATS)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in psychopathology (GAF)(12 months (At baseline, day 98, 182 and day 365))
- improvement in psychopathology (CDSS)(12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365))
- improvement in social and occupational functioning (UPSA-B)(12 months (at baseline, day 98, day 182 and day 365))
- improvement of endurance capacity(12 months (at baseline, day 98, day 182 and day 365))
- improvement in metabolic parameters(12 months (at baseline, day 98, day 182 and day 365))
- improvement in psychopathology (SOFAS)(12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365))
- improvement in quality of life(12 months (at baseline, day 182 and day 365))
- change of brain function (MRI)(12 months (at baseline, day 98, day 182 and day 365))
- change of proteomics(12 months (at baseline, day 98, day 182 and day 365))
- improvement in psychopathology (BSI-53)(12 months (At baseline, day 98, 182 and day 365))
- improvement in social and occupational functioning (FROGS)(12 months (at baseline, day 98, day 182 and day 365))
- improvement in body mass index (BMI)(12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365))
- change of medication and attitude of the study participants to therapy (DAI)(12 months (at baseline, day 98, day 182 and day 365))
- urine (testing pregnancy and drug abuse)(baseline)
- change of BDNF level(12 months (at baseline, day 98, day 182 and day 365))
研究者
Prof. Peter Falkai
Prof. Dr. med.
Ludwig-Maximilians - University of Munich