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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Healthy Volunteers; Mild Cognitive Impairment; Subjective Cognitive Impairment
• Intervention / Treatment: Dietary supplement: carnosine supplementation; Dietary supplement: supplementation with placebo; Behavioral: exercise; Behavioral: stretching

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 81369
    • University Hospital Bratislava, Comenius University
  • Bratislava, Slovakia, 84505
    • Biomedical Research Center, Slovak Academy of Sciences
• Taiwan
  • Tainan
    • Tainan City, Tainan, Taiwan, 701
      • Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise and carnosine supplementation; exercise: participants will be subjected to 4 months of supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily	Dietary supplement: carnosine supplementation; participants will be instructed to take carnosine 2 times daily; Behavioral: exercise; participants will be subjected to 4 months supervised exercise intervention
Experimental: exercise and supplementation with placebo; 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	Dietary supplement: supplementation with placebo; participants will be instructed to take placebo 2 times daily; Behavioral: exercise; participants will be subjected to 4 months supervised exercise intervention
Experimental: stretching controls and carnosine supplementation; 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; participants will be instructed to take carnosine 2 times daily; Behavioral: stretching; participants will be subjected to 4 months supervised stretching program
Experimental: stretching controls and supplementation with placebo; 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	Dietary supplement: supplementation with placebo; participants will be instructed to take placebo 2 times daily; Behavioral: stretching; participants will be subjected to 4 months supervised stretching program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose tolerance	changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)	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)	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)	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
habitual physical activity	Habitual physical activity will be determined with accelerometers	up to 36 months
physical fitness	Submaximal aerobic capacity will be determined with one mile (Rockport) walk test	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	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)	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.	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	24 months

Collaborators and Investigators

• Sponsor: Slovak Academy of Sciences
• Collaborators: National Cheng Kung University; Comenius University; University Hospital Bratislava
• Investigators: Principal Investigator: Peter Turčáni, Prof., MD, PhD, University Hospital Bratislava, Comenius University, Bratislava,; Principal Investigator: Peter Valkovič, Prof., MD, PhD, University Hospital Bratislava, Comenius University, Bratislava,; Principal Investigator: Barbara Ukropcová, Assoc. Prof., MD, PhD, Biomedical Research Center, Slovak Academy of Sciences,; Principal Investigator: Jozef Ukropec, DrSc, PhD, Biomedical Research Center, Slovak Academy of Sciences,

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: exercise training; Parkinson's disease; cognitive functions; motor functions
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Cognitive Dysfunction; Parkinson Disease; Neurodegenerative Diseases
• Other Study ID Numbers: 15-0253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No