Clinical trial NCT03330470: Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
Official title: Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Impairment
Mild Cognitive Impairment
Parkinson Disease
Healthy Volunteers
Keywords: Parkinson's disease
exercise training
motor functions
cognitive functions
Lead sponsor: Slovak Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Comenius University
name: University Hospital Bratislava
name: National Cheng Kung University
First posted: 2017-11-06
Enrollment: 26
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: glucose tolerance
timeFrame: up to 36 months
measure: learning/working memory
timeFrame: up to 36 months
measure: Balance parameter (Berg Balance Scale)
timeFrame: up to 36 months
Secondary outcomes:
measure: habitual physical activity
timeFrame: up to 36 months
measure: physical fitness
timeFrame: up to 36 months
measure: Gait parameters (Walking speed)
timeFrame: 24 months
measure: Gait parameter (Stance time)
timeFrame: 24 months
measure: Gait parameter (step length)
timeFrame: 24 months
measure: Postural parameter (magnitude of CoP displacement)
timeFrame: 24 months
measure: Postural parameter (Velocity CoP displacement)
timeFrame: 24 months
measure: Postural Sway Area
timeFrame: 24 months
measure: Postural sway path length
timeFrame: 24 months
measure: Postural sway frequency
timeFrame: 24 months
measure: Acceleration of upper and lower trunk
timeFrame: 24 months
measure: Upper and lower trunk sway area
timeFrame: 24 months
measure: Upper and lower trunk sway path
timeFrame: 24 months
measure: Upper and lower trunk sway frequency
timeFrame: 24 months
measure: Upper and lower trunk sway jerkiness
timeFrame: 24 months
measure: Angular velocity of upper and lower trunk
timeFrame: 24 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava, Comenius University
city: Bratislava
country: Slovakia
facility: Biomedical Research Center, Slovak Academy of Sciences
city: Tainan City
country: Taiwan
facility: Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University
state: Tainan
Study officials:
affiliation: University Hospital Bratislava, Comenius University, Bratislava,
name: Peter Turčáni, Prof., MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bratislava, Comenius University, Bratislava,
name: Peter Valkovič, Prof., MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Research Center, Slovak Academy of Sciences,
name: Barbara Ukropcová, Assoc. Prof., MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Research Center, Slovak Academy of Sciences,
name: Jozef Ukropec, DrSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: