An interventional study of exercise and carnosine supplementation in Subjective Cognitive Impairment, Mild Cognitive Impairment and Parkinson Disease, sponsored by Slovak Academy of Sciences. Completed at 3 sites in 2 countries. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Basic science
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.
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.
Exclusion Criteria:
exercise: participants will be subjected to 4 months of supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily
Behavioral: exercise · Dietary Supplement: carnosine supplementation
exercise: participants will be subjected to 4 months of supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily
Behavioral: exercise · Dietary Supplement: supplementation with placebo
stretching controls: participants will be subjected to 4 months of supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily
Dietary Supplement: carnosine supplementation · Behavioral: stretching
stretching controls: participants will be subjected to 4 months of supervised stretching program supplementation with placebo: participants will be instructed to take placebo 2 times daily
Behavioral: stretching · Dietary Supplement: supplementation with placebo
participants will be subjected to 4 months supervised exercise intervention
participants will be instructed to take carnosine 2 times daily
participants will be subjected to 4 months supervised stretching program
participants will be instructed to take placebo 2 times daily
glucose tolerance
changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
Time frame: up to 36 months
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)
Time frame: up to 36 months
Balance parameter (Berg Balance Scale)
Exercise related changes in ballance will be examined with the Berg Balance Scale test (max score 56)
Time frame: up to 36 months
habitual physical activity
Habitual physical activity will be determined with accelerometers
Time frame: up to 36 months
physical fitness
Submaximal aerobic capacity will be determined with one mile (Rockport) walk test
Time frame: up to 36 months
Gait parameters (Walking speed)
Walking (gait) speed will be evaluated in a subset of PD individuals with the Azure Kinect depth camera (once the technology for gait analysis will be available to the study investigators). An average walking velocity will be computed as total distance divided by time of the test (m·s-¹); measured using Microsoft Kinect for Azure
Time frame: 24 months
Gait parameter (Stance time)
Stance time will be evaluated in a subset of PD individuals, (once the technology for gait analysis will be available to the study investigators). Stance time - duration within the gait cycle when the measured leg is in contact with the ground. Measured using Microsoft Kinect for Azure as the time from when ankle joint speed in the anterior-posterior direction drops below 10% of its peak to reaching 10% in the next gait cycle, unit measure (s)
Time frame: 24 months
Gait parameter (step length)
Step length - linear distance in the anterior-posterior direction between consecutive heel strikes of opposite feet (m); measured using Microsoft Kinect for Azure as the peak distance between left and right ankle points. In a subpopulation of PD patients after (Azure Kinect) technology is available.
Time frame: 24 months
Postural parameter (magnitude of CoP displacement)
Magnitude of centre of pressure (CoP) displacement - exercise-related changes in CoP magnitude in both anterior-posterior and medial-lateral directions reflecting the whole body sway will be determined with the aid of force platform (mm)
Time frame: 24 months
Postural parameter (Velocity CoP displacement)
Velocity of centre of pressure (CoP) displacement - exercise-related changes in CoP velocity in both anterior-posterior and medial-lateral directions reflecting the whole body sway will be determined with the aid of force platform (mm/s)
Time frame: 24 months
Postural Sway Area
Postural sway area - exercise-related changes in the overall centre of pressure (CoP) displacement over a period of time computed as the area enclosed by the CoP path per unit of time will be determined with the aid of force platform (mm-2.s-1)
Time frame: 24 months
Postural sway path length
Postural sway path length - exercise-related changes in the overall centre of pressure (CoP) displacement computed as the total distance the CoP travels will be determined with the aid of force platform (mm)
Time frame: 24 months
Postural sway frequency
Postural sway frequency - exercise-related changes in the rate of the centre of pressure (CoP) oscillations in both anterior-posterior and medial-lateral directions will be determined with the aid of force platform using time-domain and frequency domain analyses (Hz)
Time frame: 24 months
Acceleration of upper and lower trunk
Acceleration of upper and lower trunk - exercise-related changes in acceleration of upper and lower trunk in both anterior-posterior and medial-lateral directions reflecting the upper body sway will be determined with the aid of inertial sensors with inbuilt 3D accelerometers (m-2)
Time frame: 24 months
Upper and lower trunk sway area
Upper and lower trunk sway area - exercise-related changes in the overall acceleration of upper and lower trunk over a period of time computed as the area enclosed by the acceleration path per unit of time will be determined with the aid of inertial sensors with inbuilt 3D accelerometers (m-2.s-5)
Time frame: 24 months
Upper and lower trunk sway path
Upper and lower trunk sway path - exercise-related changes in the overall acceleration of upper and lower trunk computed as the total length of the acceleration path will be determined with the aid of inertial sensors with inbuilt 3D accelerometers (m.s-2)
Time frame: 24 months
Upper and lower trunk sway frequency
Upper and lower trunk sway frequency - exercise-related changes in the rate of upper and lower trunk acceleration in both anterior-posterior and medial-lateral directions will be determined with the aid of inertial sensors with inbuilt 3D accelerometers using time-domain and frequency domain analyses (Hz)
Time frame: 24 months
Upper and lower trunk sway jerkiness
Upper and lower trunk sway jerkiness - exercise-related changes in the jerk of upper and lower trunk computed as a time derivative of upper and lower trunk acceleration will be determined with the aid of inertial sensors with inbuilt 3D accelerometers (m-2.s-5)
Time frame: 24 months
Angular velocity of upper and lower trunk
Angular velocity of upper and lower trunk - exercise-related changes in angular velocity of upper and lower trunk in both anterior-posterior and medial-lateral directions will be determined with the aid of inertial sensors with inbuilt 3D gyroscopes (rad.s-1)
Time frame: 24 months
Plan to share: No
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Slovak Academy of Sciences