Healthy Volunteers, Mild Cognitive Impairment, Parkinson Disease, Subjective Cognitive Impairment
Conditions
Keywords
Parkinson's disease, exercise training, motor functions, cognitive functions
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.
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
Sponsors
Comenius University
University Hospital Bratislava
National Cheng Kung University
Slovak Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
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
* Serious systemic cardiovascular, hepatic, renal disease, cancer * Lack of compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| habitual physical activity | up to 36 months | Habitual physical activity will be determined with accelerometers |
| 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) |
| 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) |
| physical fitness | up to 36 months | Submaximal aerobic capacity will be determined with one mile (Rockport) walk test |
| 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 |
Countries
Slovakia, Taiwan
Outcome results
None listed