Healthy Volunteers Clinical Trial
Official title:
Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Serious systemic cardiovascular, hepatic, renal disease, cancer - Lack of compliance |
Country | Name | City | State |
---|---|---|---|
Slovakia | Biomedical Research Center, Slovak Academy of Sciences | Bratislava | |
Slovakia | University Hospital Bratislava, Comenius University | Bratislava | |
Taiwan | Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University | Tainan City | Tainan |
Lead Sponsor | Collaborator |
---|---|
Slovak Academy of Sciences | Comenius University, National Cheng Kung University, University Hospital Bratislava |
Slovakia, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | glucose tolerance | changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l) | up to 36 months | |
Primary | learning/working memory | exercise related changes in learning/working memory will be determined with the aid of Addenbrook's cognitive test (maximum test score 100) | up to 36 months | |
Primary | motoric functions - Berg Balance Scale | exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56) | up to 36 months | |
Secondary | habitual physical activity | Habitual physical activity will be determined with accelerometers | up to 36 months | |
Secondary | physical fitness | Submaximal aerobic capacity will be determined with one mile walk test | up to 36 months |
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