Subjective Cognitive ImpairmentNCT03330470
Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
A study testing exercise, carnosine supplementation and stretching in people with Subjective Cognitive Impairment and Mild Cognitive Impairment, run by Slovak Academy of Sciences at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Impairment, Mild Cognitive Impairment, Parkinson Disease
- What is being tested?
- exercise, carnosine supplementation and stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jan 2017to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious systemic cardiovascular, hepatic, renal disease, cancer
- Lack of compliance
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Slovakia2 sites
University Hospital Bratislava, Comenius University
Bratislava, 81369
Biomedical Research Center, Slovak Academy of Sciences
Bratislava, 84505
Taiwan1 site
Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University
Tainan, Tainan, 701
About this study
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.
- Conditions
- Subjective Cognitive Impairment, Mild Cognitive Impairment, Parkinson Disease, Healthy Volunteers
- Being tested
- exercise, carnosine supplementation, stretching, supplementation with placebo
- Keywords
- Parkinson's disease, exercise training, motor functions, cognitive functions
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
participants will be subjected to 4 months supervised exercise intervention
carnosine supplementationDietary supplement
participants will be instructed to take carnosine 2 times daily
stretchingBehavioural
participants will be subjected to 4 months supervised stretching program
supplementation with placeboDietary supplement
participants will be instructed to take placebo 2 times daily
| Study group | Role | What they receive |
|---|---|---|
| exercise and carnosine supplementation | Experimental | exercise: participants will be subjected to 4 months of supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily Receives: Behavioral: exercise; Dietary Supplement: carnosine supplementation |
| exercise and supplementation with placebo | Experimental | 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 Receives: Behavioral: exercise; Dietary Supplement: supplementation with placebo |
| stretching controls and carnosine supplementation | Experimental | 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 Receives: Dietary Supplement: carnosine supplementation; Behavioral: stretching |
| stretching controls and supplementation with placebo | Experimental | 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 Receives: Behavioral: stretching; Dietary Supplement: supplementation with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose tolerance
changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
Measured: 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)
Measured: 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)
Measured: up to 36 months
Secondary outcomes (16)
habitual physical activity
Habitual physical activity will be determined with accelerometers
Measured: up to 36 months
physical fitness
Submaximal aerobic capacity will be determined with one mile (Rockport) walk test
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jan 2017
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Comenius University, University Hospital Bratislava, National Cheng Kung University
- Responsible party
- Principal investigator, Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences
- Investigators
- 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,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330470
- Sponsor's protocol ID
- 15-0253
- Status last verified
- May 2025
- First submitted
- 17 Oct 2017
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT03330470
- Acronym / sponsor ID
- 15-0253
- Conditions
- Subjective Cognitive Impairment, Mild Cognitive Impairment, Parkinson Disease, Healthy Volunteers
- Keywords
- Parkinson's disease, exercise training, motor functions, cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- Comenius University, University Hospital Bratislava, National Cheng Kung University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| exercise and carnosine supplementation | Experimental | Behavioral: exercise, Dietary Supplement: carnosine supplementationexercise: participants will be subjected to 4 months of supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily |
| exercise and supplementation with placebo | Experimental | Behavioral: exercise, Dietary Supplement: supplementation with placeboexercise: participants will be subjected to 4 months of supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily |
| stretching controls and carnosine supplementation | Experimental | Dietary Supplement: carnosine supplementation, Behavioral: stretchingstretching controls: participants will be subjected to 4 months of supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily |
| stretching controls and supplementation with placebo | Experimental | Behavioral: stretching, Dietary Supplement: supplementation with placebostretching 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 |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Serious systemic cardiovascular, hepatic, renal disease, cancer
- Lack of compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseparticipants will be subjected to 4 months supervised exercise intervention | Behavioural | exercise and carnosine supplementation, exercise and supplementation with placebo |
| carnosine supplementationparticipants will be instructed to take carnosine 2 times daily | Dietary supplement | exercise and carnosine supplementation, stretching controls and carnosine supplementation |
| stretchingparticipants will be subjected to 4 months supervised stretching program | Behavioural | stretching controls and carnosine supplementation, stretching controls and supplementation with placebo |
| supplementation with placeboparticipants will be instructed to take placebo 2 times daily | Dietary supplement | exercise and supplementation with placebo, stretching controls and supplementation with placebo |
Primary outcome
glucose tolerance
Time frame: up to 36 months
changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
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)
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)
16 secondary outcomes
habitual physical activity
Time frame: up to 36 months
physical fitness
Time frame: up to 36 months
Gait parameters (Walking speed)
Time frame: 24 months
Gait parameter (Stance time)
Time frame: 24 months
Gait parameter (step length)
Time frame: 24 months
Postural parameter (magnitude of CoP displacement)
Time frame: 24 months
Postural parameter (Velocity CoP displacement)
Time frame: 24 months
Postural Sway Area
Time frame: 24 months
Postural sway path length
Time frame: 24 months
Postural sway frequency
Time frame: 24 months
Acceleration of upper and lower trunk
Time frame: 24 months
Upper and lower trunk sway area
Time frame: 24 months
Upper and lower trunk sway path
Time frame: 24 months
Upper and lower trunk sway frequency
Time frame: 24 months
Upper and lower trunk sway jerkiness
Time frame: 24 months
Angular velocity of upper and lower trunk
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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,
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise, carnosine supplementation and stretching in people with Subjective Cognitive Impairment and Mild Cognitive Impairment, run by Slovak Academy of Sciences at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovakia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose tolerance (time frame: up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.