CClinicalTrials.gg
CompletedNCT03330470Updated May 28, 2025

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Subjective Cognitive Impairment
  • Mild Cognitive Impairment
  • Parkinson Disease
  • Healthy Volunteers

Keywords

  • Parkinson's disease
  • exercise training
  • motor functions
  • cognitive functions
03

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Serious systemic cardiovascular, hepatic, renal disease, cancer
  • Lack of compliance
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • 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

    Behavioral: exercise · Dietary Supplement: carnosine supplementation

  • 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

    Behavioral: exercise · Dietary Supplement: supplementation with placebo

  • 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 · Behavioral: stretching

  • 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

    Behavioral: stretching · Dietary Supplement: supplementation with placebo

Interventions

  • Behavioralexercise

    participants will be subjected to 4 months supervised exercise intervention

  • Dietary supplementcarnosine supplementation

    participants will be instructed to take carnosine 2 times daily

  • Behavioralstretching

    participants will be subjected to 4 months supervised stretching program

  • Dietary supplementsupplementation with placebo

    participants will be instructed to take placebo 2 times daily

05

What researchers measure

Primary outcomes

  1. glucose tolerance

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

    Time frame: up to 36 months

  2. 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

  3. 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

Secondary outcomes

  1. habitual physical activity

    Habitual physical activity will be determined with accelerometers

    Time frame: up to 36 months

  2. physical fitness

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

    Time frame: up to 36 months

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

06

Study locations

3 sites
  • University Hospital Bratislava, Comenius University
    Bratislava, 81369, Slovakia
  • Biomedical Research Center, Slovak Academy of Sciences
    Bratislava, 84505, Slovakia
  • Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University
    Tainan City, Tainan 701, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03330470
Lead sponsor
Slovak Academy of Sciences
Collaborators
Comenius University, University Hospital Bratislava, National Cheng Kung University
Responsible party
Barbara Ukropcová, MD, PhD (Prof. MD, PhD, Slovak Academy of Sciences) — Principal investigator
First posted
Nov 6, 2017
Start date
Jan 1, 2017
Primary completion
Jun 30, 2023
Completion
Sep 30, 2023
Last update
May 28, 2025

Study contacts

Peter Turčáni, Prof., MD, PhD
principal investigator · University Hospital Bratislava, Comenius University, Bratislava,
Peter Valkovič, Prof., MD, PhD
principal investigator · University Hospital Bratislava, Comenius University, Bratislava,
Barbara Ukropcová, Assoc. Prof., MD, PhD
principal investigator · Biomedical Research Center, Slovak Academy of Sciences,
Jozef Ukropec, DrSc, PhD
principal investigator · Biomedical Research Center, Slovak Academy of Sciences,

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion