Skip to main content
OpenTrials
Completed

NCT Number: NCT03330470

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subjective Cognitive Impairment Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Healthy Volunteers Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

participants will be subjected to 4 months supervised exercise intervention

carnosine supplementation

Dietary Supplement

participants will be instructed to take carnosine 2 times daily

Stretching

Behavioral

participants will be subjected to 4 months supervised stretching program

supplementation with placebo

Dietary Supplement

participants will be instructed to take placebo 2 times daily

Primary outcomes

  1. glucose tolerance

    Time frame: up to 36 months

    changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)

  2. learning/working memory

    Time frame: 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)

  3. Balance parameter (Berg Balance Scale)

    Time frame: up to 36 months

    Exercise related changes in ballance will be examined with the Berg Balance Scale test (max score 56)

Secondary outcomes

  1. habitual physical activity

    Time frame: up to 36 months

    Habitual physical activity will be determined with accelerometers

  2. physical fitness

    Time frame: up to 36 months

    Submaximal aerobic capacity will be determined with one mile (Rockport) walk test

  3. Gait parameters (Walking speed)

    Time frame: 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

  4. Gait parameter (Stance time)

    Time frame: 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)

  5. Gait parameter (step length)

    Time frame: 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.

  6. Postural parameter (magnitude of CoP displacement)

    Time frame: 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)

  7. Postural parameter (Velocity CoP displacement)

    Time frame: 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)

  8. Postural Sway Area

    Time frame: 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)

  9. Postural sway path length

    Time frame: 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)

  10. Postural sway frequency

    Time frame: 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)

  11. Acceleration of upper and lower trunk

    Time frame: 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)

  12. Upper and lower trunk sway area

    Time frame: 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)

  13. Upper and lower trunk sway path

    Time frame: 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)

  14. Upper and lower trunk sway frequency

    Time frame: 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)

  15. Upper and lower trunk sway jerkiness

    Time frame: 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)

  16. Angular velocity of upper and lower trunk

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Slovak Academy of Sciences

Other Gov

Collaborators

  • Comenius University
  • National Cheng Kung University
  • University Hospital Bratislava

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2017
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.