Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- glucose tolerance
研究概览
简要总结
The purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (SCI) or mild (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease. The investigators assume the immediate intervention-associated health benefit for volunteers.
详细描述
Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in Biomedical Research Center, Slovak Academy of Sciences, University Hospital Bratislava and Comenius University, Bratislava will be employed. Gait and balance parameters will be examined and analysed at the Department of Behavioural Neuroscience, Centre of Experimental Medicine, Slovak Academy of Sciences, Bratislava, Slovakia Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Age 55 - 80 years
- •Presence of Subjective Cognitive Impairment (SCI), Mild Cognitive Impairment (MCI) or early stage of Parkinson's Disease (Hoehn-Yahr 1st-2nd stage), assessed by experienced neurologist
排除标准
- •Serious systemic cardiovascular, hepatic, renal disease, cancer
- •Lack of compliance
结局指标
主要结局
glucose tolerance
时间窗: up to 36 months
changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
learning/working memory
时间窗: up to 36 months
exercise related changes in learning/working memory will be determined with the aid of Addenbrook's cognitive test (maximum test score 100)
Balance parameter (Berg Balance Scale)
时间窗: up to 36 months
Exercise related changes in ballance will be examined with the Berg Balance Scale test (max score 56)
次要结局
- habitual physical activity(up to 36 months)
- physical fitness(up to 36 months)
- Gait parameters (Walking speed)(24 months)
- Gait parameter (Stance time)(24 months)
- Gait parameter (step length)(24 months)
- Postural parameter (magnitude of CoP displacement)(24 months)
- Postural parameter (Velocity CoP displacement)(24 months)
- Postural Sway Area(24 months)
- Postural sway path length(24 months)
- Postural sway frequency(24 months)
- Acceleration of upper and lower trunk(24 months)
- Upper and lower trunk sway area(24 months)
- Upper and lower trunk sway path(24 months)
- Upper and lower trunk sway frequency(24 months)
- Upper and lower trunk sway jerkiness(24 months)
- Angular velocity of upper and lower trunk(24 months)
研究者
Barbara Ukropcová, MD, PhD
Prof. MD, PhD
Slovak Academy of Sciences