Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

Not Applicable

Completed

• Conditions: Subjective Cognitive Impairment; Mild Cognitive Impairment; Parkinson Disease; Healthy Volunteers

• Registration Number: NCT03330470
• Lead Sponsor: Slovak Academy of Sciences

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
glucose tolerance	up to 36 months	changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
learning/working memory	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)	up to 36 months	Exercise related changes in ballance will be examined with the Berg Balance Scale test (max score 56)

Secondary Outcome Measures

Name	Time	Method
Gait parameters (Walking speed)	24 months	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
Gait parameter (Stance time)	24 months	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)
Gait parameter (step length)	24 months	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.
Postural parameter (magnitude of CoP displacement)	24 months	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)
Postural parameter (Velocity CoP displacement)	24 months	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)
Postural Sway Area	24 months	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)
Postural sway path length	24 months	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)
Postural sway frequency	24 months	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)
Acceleration of upper and lower trunk	24 months	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)
Upper and lower trunk sway area	24 months	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)
Upper and lower trunk sway path	24 months	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)
Upper and lower trunk sway frequency	24 months	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)
Upper and lower trunk sway jerkiness	24 months	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)
Angular velocity of upper and lower trunk	24 months	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)
habitual physical activity	up to 36 months	Habitual physical activity will be determined with accelerometers
physical fitness	up to 36 months	Submaximal aerobic capacity will be determined with one mile (Rockport) walk test

Trial Locations

Locations (3)

University Hospital Bratislava, Comenius University; 🇸🇰 Bratislava, Slovakia

Biomedical Research Center, Slovak Academy of Sciences; 🇸🇰 Bratislava, Slovakia

Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University; 🇨🇳 Tainan City, Tainan, Taiwan