Effect of High Intensity Interval Training on Mechanisms of Neuroplasticity in Parkinson's Disease Patients

NCT04204551 | Unknown

• 1 other identifier: 2017/25/B/NZ7/02795
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There are experimental evidences of the important role of high intensity physical exercise in Parkinson's disease (PD) treatment, that induces similar effects to pharmacotherapy. So far, the mechanisms of the impact of these changes on the brain subcortical and cortical regions functioning, motor activities and cognitive functions are still not clear. The aim of this longitudinal (prospective) human experiment is to examine the effects of two cycles of 12-weeks high-intensity interval training (HIIT) on: (i) the level of dopamine (DA) in putamen in striatum, (ii) neurophysiological function of subcortical and cortical motor structures and skeletal muscle activity, (iii) psychomotor behaviors critically associated with dopamine dependent neural structures functioning and (iv) neurotrophic factors' secretion level in blood. The investigators will recruit 40 PD individuals, who will be divided into two groups: one of them will perform two 12-weeks cycles of HIIT (PD-TR), and the other will not be trained (PD-NTR) with HIIT. The investigators will also recruit 20 age-matched healthy controls (H-CO) as additional control group who will not perform the HIIT. The PD-TR group will perform the two 12-weeks cycles of the HIIT, that induces beneficial, neuroplastic changes and alleviates the PD symptoms, what was found in earlier studies. All PD subjects (PD-TR and PD-NTR) will be examined during their medication "OFF-phase" (it means after dopaminergic drugs withdrawal) before (Pre) and after (Post) training cycles (first training cycle - HIIT 1; second training cycle - HIIT 2), and namely: Pre HIIT 1, 1 week-, 1.5 month- and 3 months-Post HIIT 1; and then similarly 1 week-, 1.5 month- and 3 months-Post HIIT 2. The subject from H-CO will be tested only once. To examine the assumed HIIT-induced changes in brain functioning the investigators will apply: (i) the positron emission tomography (PET), (ii) the functional magnetic resonance imaging (fMRI), (iii) electroencephalography (EEG) and (iv) an analysis of neurotrophic factors secretion level in blood. The investigators will also assess motor and non-motor symptoms of PD and psychomotor behaviors based on neuropsychological tests of cognitive functions and manual dexterity. The results of this project will help to answer the fundamental questions about HIIT induced mechanisms of neuroplasticity in PD patients, what is important from scientific and treatment-strategy point of view.

Conditions

Parkinson's Disease; Physical Activity; Neurorehabilitation; Neuroplasticity

Keywords

Parkinson's Disease; Physical Activity; Neurorehabilitation; Neuroplasticity; Motor Function; Cognitive Function; Neuroimaging

Outcome Measures

Primary Outcomes (98)

• Positron Emission Tomography (PET) with 18F-dopa - PET imaging with [18F]fluorodopa uptake.

  To examine presynaptic striatal DA availability (in dorsal putamen) using PET imaging method with the 18F-dopa - \[18F\]fluorodopa uptake. The recordings will be expressed in Ki ref values \[Ki ref\] and Standard Uptake Values \[SUV\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• Positron Emission Tomography (PET) with 18F-dopa - PET imaging with [18F]fluorodopa uptake.

  To examine presynaptic striatal DA availability (in dorsal putamen) using PET imaging method with the 18F-dopa - \[18F\]fluorodopa uptake. The recordings will be expressed in Ki ref values \[Ki ref\] and Standard Uptake Values \[SUV\].

  1-week Post-HIIT 1

• Positron Emission Tomography (PET) with 18F-dopa - PET imaging with [18F]fluorodopa uptake.

  To examine presynaptic striatal DA availability (in dorsal putamen) using PET imaging method with the 18F-dopa - \[18F\]fluorodopa uptake. The recordings will be expressed in Ki ref values \[Ki ref\] and Standard Uptake Values \[SUV\].

  3-months Post-HIIT 2

• functional Magnetic Resonance Imaging (fMRI) - metabolic activity of brain recorded with MRI scanner.

  To evaluate neurophysiological functions of brain subcortical and cortical structures using MRI scanner. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The image recordings will express metabolic brain activity as expressed in fMRI response \[% BOLD signal\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• functional Magnetic Resonance Imaging (fMRI) - metabolic activity of brain recorded with MRI scanner.

  To evaluate neurophysiological functions of brain subcortical and cortical structures using MRI scanner. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The image recordings will express metabolic brain activity as expressed in fMRI response \[% BOLD signal\].

  1-week Post-HIIT 1

• functional Magnetic Resonance Imaging (fMRI) - metabolic activity of brain recorded with MRI scanner.

  To evaluate neurophysiological functions of brain subcortical and cortical structures using MRI scanner. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The image recordings will express metabolic brain activity as expressed in fMRI response \[% BOLD signal\].

  3-months Post-HIIT 2

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  1-week Post-HIIT 1

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  1.5-month Post-HIIT 1

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  3-months Post-HIIT 1

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  1-week Post-HIIT 2

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  1.5-month Post-HIIT 2

• Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts \[µV\].

  3-months Post-HIIT 2

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  1-week Post-HIIT 1

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  1.5-month Post-HIIT 1

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  3-months Post-HIIT 1

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  1-week Post-HIIT 2

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  1.5-month Post-HIIT 2

• Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds \[ms\].

  3-months Post-HIIT 2

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  1-week Post-HIIT 1

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  1.5-month Post-HIIT 1

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  3-months Post-HIIT 1

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  1-week Post-HIIT 2

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  1.5-month Post-HIIT 2

• Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

  To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels \[dB\].

  3-months Post-HIIT 2

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  1-week Post-HIIT 1

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  1.5-month Post-HIIT 1

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  3-months Post-HIIT 1

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  1-week Post-HIIT 2

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  1.5-month Post-HIIT 2

• Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

  To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts \[mV\].

  3-months Post-HIIT 2

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  1-week Post-HIIT 1

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  1.5-month Post-HIIT 1

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  3-months Post-HIIT 1

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  1-week Post-HIIT 2

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  1.5-month Post-HIIT 2

• Purdue Pegboard Test (PPT) - neuropsychological test

  To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets \[number of pins or sets\].

  3-months Post-HIIT 2

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 1

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 1

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 1

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 2

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 2

• TMT-A - trail making test, part A

  TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 2

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 1

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 1

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 1

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 2

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 2

• TMT-B - trail making test, part B

  TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 2

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 1

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 1

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 1

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 2

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 2

• ST-I - Stroop Test, part I

  ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 2

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 1

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 1

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 1

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1-week Post-HIIT 2

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  1.5-month Post-HIIT 2

• ST-II - Stroop Test, part II

  ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in \[s\].

  3-months Post-HIIT 2

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  1-week Post-HIIT 1

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  1.5-month Post-HIIT 1

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  3-months Post-HIIT 1

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  1-week Post-HIIT 2

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  1.5-month Post-HIIT 2

• UPDRS - unified Parkinson's disease rating scale

  Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in \[points\] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

  3-months Post-HIIT 2

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  1-week Post-HIIT 1

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  1.5-month Post-HIIT 1

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  3-months Post-HIIT 1

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  1-week Post-HIIT 2

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  1.5-month Post-HIIT 2

• BDNF - brain derived neurotrophic factor

  BDNF secretion level in blood expressed in \[pg/mL\]

  3-months Post-HIIT 2

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  1-week Post-HIIT 1

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  1.5-month Post-HIIT 1

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  3-months Post-HIIT 1

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  1-week Post-HIIT 2

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  1.5-month Post-HIIT 2

• NGF - nerve growth factor

  NGF secretion level in blood expressed in \[pg/mL\]

  3-months Post-HIIT 2

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  1-week Post-HIIT 1

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  1.5-month Post-HIIT 1

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  3-months Post-HIIT 1

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  1-week Post-HIIT 2

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  1.5-month Post-HIIT 2

• IGF 1 - insulin-like growth factor 1

  IGF 1 secretion level in blood expressed in \[pg/mL\]

  3-months Post-HIIT 2

• Val66Met polymorphism of BDNF - genotyping of BDNF polymorphism

  The single nucleotide polymorphism (SNP) BDNF Val66Met variant (rs 6265) will be genotyped by using the TaqMan SNP genotyping assay. Thermal cycling and end-point PCR (polymerase chain reaction) analysis will be performed on the Rotor-Gene Q 5plex real-time PCR Cycler and will be analyzed by Q-Rex-software. Genotype of BDNF polymorphism will be expressed in percentge values \[% of genotype\].

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Secondary Outcomes (15)

• H&Y scale - Hoehn and Yahr scale

  Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

• H&Y scale - Hoehn and Yahr scale

  1-week Post-HIIT 1

• H&Y scale - Hoehn and Yahr scale

  1.5-month Post-HIIT 1

• H&Y scale - Hoehn and Yahr scale

  3-months Post-HIIT 1

• H&Y scale - Hoehn and Yahr scale

  1-week Post-HIIT 2

Study Arms (3)

PD-TR

EXPERIMENTAL

Intervention exercise, dose: two cycles of 12-week HIIT program (three times a week) separated with 3 months break \& conventional physical therapy

Behavioral: high-intensity interval training (HIIT); Behavioral: conventional physical therapy

PD-NTR

ACTIVE COMPARATOR

conventional physical therapy

Behavioral: conventional physical therapy

Healthy Controls

NO INTERVENTION

healthy controls without any kind of therapy

Interventions

high-intensity interval training (HIIT) BEHAVIORAL

Two 12-week HIIT cycles will be divided with 3 months of break. Each HIIT cycle will consist of three 1-hour training sessions weekly. Each 1-hour training session will consist of 10-minutes warm-up (at slow voluntary speed), 40-minutes of interval exercise and 10-minutes cool-down phase. The interval exercise part will consist of 10 sets of 4 minutes interval including 2-minutes cycling at ≥ 60 \[rpm\], but preferably at 80-90 \[rpm\] (fast phase of interval) and 2-minutes cycling at ≤ 60 \[rpm\] (slow phase of interval). The training will be performed on a stationary cycle ergometer (MONARK, Ergomedic 874E, Sweden). The heart rate (HR, \[bpm\]) will be measured by Polar system (Polar, Finland). The patients will pedal on the cycloergometer at 60%-80% of their individualized HRmax.

PD-TR

conventional physical therapy BEHAVIORAL

Conventional physical therapy as prescribed and provided by the National Health Fund of Poland, which includes activities for improving motor control, but without any kind of moderate or high intensity aerobic interval or continuous physical training (example: cycle ergometer, treadmill, or Nordic walking training)

PD-NTR; PD-TR

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for PD patients: age 45-65 years-old; diagnosis of idiopathic PD; and modified Hoehn and Yahr stages between 1.5 and 3
• for healthy controls: age-matched to PD patients, lack of neurological disorders
• all participants will also satisfy the following eligibility criteria: (i) proficient in Polish; (ii) no significant cognitive impairments (dementia), as assessed by the MMSE test (Folstein et al., 1975) score ≥ 27; (iii) no prior history of neurological, psychiatric, or other disorders that may influence CNS structure and function; (iv) no current medication to affect cognitive psychomotor functioning (opioid analgesics, anxiolytics or antidepressants) and (v) signed informed consent.

You may not qualify if:

• for PD patients: (1) presence of other neurological disorders, (2) any cardiovascular and respiratory system restrictions and/or motor deficits that could limit performance in high-speed pedaling on a cycle ergometer or in the conventional physical therapy and (3) practicing any regular intensive physical activity except for physical therapy for PD
• for healthy controls: presence of neurological disorders

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Józef Piłsudski University of Physical Education: collaborator
• Medical University of Warsaw: collaborator
• Polish Academy of Sciences: collaborator
• Wroclaw Medical University: collaborator
• Military Institute od Medicine National Research Institute: collaborator

Study Sites (1)

University School of Physical Education in Wroclaw

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jaroslaw Marusiak, PhD

  University School of Physical Education in Wroclaw, Wroclaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Rokita, PhD

CONTACT

713473101; rektor@awf.wroc.pl

Zofia Tarnowska, MSc

CONTACT

713473214; zofia.tarnowska@awf.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 19, 2019
• Study Start: February 15, 2018
• Primary Completion: September 25, 2020
• Study Completion: December 18, 2020
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)