Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Training Induced Plasticity of Motor Control Mechanisms in Parkinson's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753503
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
Wroclaw Medical University
University School of Physical Education, Krakow, Poland
Information provided by (Responsible Party):
Jaroslaw Marusiak, University School of Physical Education in Wroclaw

Brief Summary:

There are experimental evidences of the important role of exercise in the PD, 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 human experiment is to examine the effects of cycle of 8-week high-intensity interval training (HIIT) on: (i) neurophysiological function of cortical motor structures and skeletal muscle actvity, (ii) psychomotor behavior critically associated with dopamine dependent neural structures functioning and (iii) 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 8-weeks cycle of HIIT (PD-TR), and the other will not (PD-NTR). The investigators will recruit also 20 age-matched healthy controls (H-CO) as additional control group who will not perform the HIIT. All PD subjects will be examined during their medication "OFF-phase" pre HIIT and 1 week-, 1 month-POST cycle of HIIT. The subject from H-CO will be tested only once. To examine the assumed HIIT-induced changes in brain functioning the investigators will use: (i) EEG (recorded simultaneously with EMG) methods to assess an amplitude, location and directionality of brain electrical current of cortical regions and strength of intra-cortical network interactions during motor tasks performance. During the EEG experiments the subjects will perform (i) bimanual anti-phase DA level dependent motor tasks (during which the investigators will record EMG, force). The investigators will also assess motor and non-motor symptoms of PD and functional test of manual dexterity to evaluate a quality psychomotor behavior.

Using these methods the investigators will determine in detail the mechanisms of functioning of the CNS in PD patients, with emphasis on the cortical interactions that are dependent on synthesis and DA transmission. The results of the study will help to answer the fundamental questions about HIIT induced neuroplasticity in PD patients, as well as complement the lack in knowledge about the mechanisms of exercise-induced changes in PD, and as a consequence it could enrich the golden standard of treatment in PD from pharmacotherapy toward implementation of precise evidence based rehabilitation.


Condition or disease Intervention/treatment Phase
Parkinson Disease Physical Activity Behavioral: exercise Behavioral: conventional physical therapy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Training Induced Plasticity of Motor Control Mechanisms in Parkinson's Disease Patients
Actual Study Start Date : November 8, 2012
Actual Primary Completion Date : November 9, 2015
Actual Study Completion Date : November 9, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PD-TR

Intervention:

exercise, dose: 8-week HIIT program (three times a week) & conventional physical therapy

Behavioral: exercise
exercised three times a week in the 8-week HIIT program

Behavioral: conventional physical therapy
Active Comparator: PD-NTR
conventional physical therapy
Behavioral: conventional physical therapy
No Intervention: Healthy controls
healthy controls without any kind of therapy



Primary Outcome Measures :
  1. Electroencephalography (EEG) - electrical activity of brain cortex recorded from scalp using surface electrodes. [ Time Frame: Baseline ]
    To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 64-chanel system. The recordings will be conducted during bimanual motor tasks and at rest. The recordings will be expressed in microvolts [µV].

  2. Electroencephalography (EEG) - electrical activity of brain cortex recorded from scalp using surface electrodes. [ Time Frame: 1-week-post HIIT cycle ]
    To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 64-chanel system. The recordings will be conducted during bimanual motor tasks and at rest. The recordings will be expressed in microvolts [µV].

  3. Electroencephalography (EEG) - electrical activity of brain cortex recorded from scalp using surface electrodes. [ Time Frame: 1-month-post HIIT cycle ]
    To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 64-chanel system. The recordings will be conducted during bimanual motor tasks and at rest. The recordings will be expressed in microvolts [µV].

  4. Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes. [ Time Frame: Baseline ]
    To evaluate neurophysiological functions of muscles engaged in an activity (hand and forearm muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during bimanual motor tasks and at rest. The recordings will be expressed in milivolts [mV].

  5. Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes. [ Time Frame: 1-week-post HIIT cycle ]
    To evaluate neurophysiological functions of muscles engaged in an activity (hand and forearm muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during bimanual motor tasks and at rest. The recordings will be expressed in milivolts [mV].

  6. Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes. [ Time Frame: 1-month-post HIIT cycle ]
    To evaluate neurophysiological functions of muscles engaged in an activity (hand and forearm muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during bimanual motor tasks and at rest. The recordings will be expressed in milivolts [mV].

  7. BDNF - brain derived neurotrophic factor [ Time Frame: Baseline ]
    BDNF secretion level in blood expressed in [pg/mL]

  8. BDNF - brain derived neurotrophic factor [ Time Frame: 1-week-post HIIT cycle ]
    BDNF secretion level in blood expressed in [pg/mL]

  9. BDNF - brain derived neurotrophic factor [ Time Frame: 1-month-post HIIT cycle ]
    BDNF secretion level in blood expressed in [pg/mL]

  10. NGF - nerve growth factor [ Time Frame: Baseline ]
    NGF secretion level in blood expressed in [pg/mL]

  11. NGF - nerve growth factor [ Time Frame: 1-week-post HIIT cycle ]
    NGF secretion level in blood expressed in [pg/mL]

  12. NGF - nerve growth factor [ Time Frame: 1-month-post HIIT cycle ]
    NGF secretion level in blood expressed in [pg/mL]

  13. IGF 1 - insulin-like growth factor 1 [ Time Frame: Baseline ]
    IGF 1 secretion level in blood expressed in [pg/mL]

  14. IGF 1 - insulin-like growth factor 1 [ Time Frame: 1-week-post HIIT cycle ]
    IGF 1 secretion level in blood expressed in [pg/mL]

  15. IGF 1 - insulin-like growth factor 1 [ Time Frame: 1-month-post HIIT cycle ]
    IGF 1 secretion level in blood expressed in [pg/mL]

  16. Force measurements of both hands' index fingers motor control [ Time Frame: Baseline ]
    force development measurements of self initiated bimanual anti-phase index finger movements, using force transducers system. The force will be expressed in [N], the time of force development in [s] and the rate of force development in [N/s].

  17. Force measurements of both hands' index fingers motor control [ Time Frame: 1-week-post HIIT cycle ]
    force development measurements of self initiated bimanual anti-phase index finger movements, using force transducers system. The force will be expressed in [N], the time of force development in [s] and the rate of force development in [N/s].

  18. Force measurements of both hands' index fingers motor control [ Time Frame: 1-month-post HIIT cycle ]
    force development measurements of self initiated bimanual anti-phase index finger movements, using force transducers system. The force will be expressed in [N], the time of force development in [s] and the rate of force development in [N/s].

  19. Force measurements of bimanual dexterity function [ Time Frame: Baseline ]
    force development measurements of self initiated bimanual anti-phase hand grip-load function, using force transducers system. The force will be expressed in [N], the time of force development in [s] and the rate of force development in [N/s].

  20. Force measurements of bimanual dexterity function [ Time Frame: 1-week-post HIIT cycle ]
    force development measurements of self initiated bimanual anti-phase hand grip-load function, using force transducers system.The force will be expressed in [N], the time of force development in [s] and the rate of force development in [N/s].

  21. Force measurements of bimanual dexterity function [ Time Frame: 1-month-post HIIT cycle ]
    force development measurements of self initiated bimanual anti-phase hand grip-load function, using force transducers system. The force will be expressed in [N], the time of force development in [s] and the rate of force development in [N/s].

  22. TMT-A - trail making test, part A [ Time Frame: Baseline ]
    TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

  23. TMT-A - trail making test, part A [ Time Frame: 1-week-post HIIT cycle ]
    TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

  24. TMT-A - trail making test, part A [ Time Frame: 1-month-post HIIT cycle ]
    TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

  25. TMT-B - trail making test, part B [ Time Frame: Baseline ]
    TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

  26. TMT-B - trail making test, part B [ Time Frame: 1-week-post HIIT cycle ]
    TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

  27. TMT-B - trail making test, part B [ Time Frame: 1-month-post HIIT cycle ]
    TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

  28. ST-I - Stroop Test, part I [ Time Frame: Baseline ]
    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].

  29. ST-I - Stroop Test, part I [ Time Frame: 1-week-post HIIT cycle ]
    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].

  30. ST-I - Stroop Test, part I [ Time Frame: 1-month-post HIIT cycle ]
    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].

  31. ST-II - Stroop Test, part II [ Time Frame: Baseline ]
    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].

  32. ST-II - Stroop Test, part II [ Time Frame: 1-week-post HIIT cycle ]
    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].

  33. ST-II - Stroop Test, part II [ Time Frame: 1-month-post HIIT cycle ]
    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].


Secondary Outcome Measures :
  1. UPDRS - unified Parkinson's disease rating scale [ Time Frame: Baseline ]
    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).

  2. UPDRS - unified Parkinson's disease rating scale [ Time Frame: 1-week-post HIIT cycle ]
    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. UPDRS - unified Parkinson's disease rating scale [ Time Frame: 1-month-post HIIT cycle ]
    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).

  4. H&Y scale - Hoehn and Yahr scale [ Time Frame: Baseline ]
    Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

  5. H&Y scale - Hoehn and Yahr scale [ Time Frame: 1-week-post HIIT cycle ]
    Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

  6. H&Y scale - Hoehn and Yahr scale [ Time Frame: 1-month-post HIIT cycle ]
    Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

  7. S&E DLA scale - Schwab and England Daily Living Activity Scale [ Time Frame: Baseline ]
    S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score decribes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

  8. S&E DLA scale - Schwab and England Daily Living Activity Scale [ Time Frame: 1-week-post HIIT cycle ]
    S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score decribes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

  9. S&E DLA scale - Schwab and England Daily Living Activity Scale [ Time Frame: 1-month-post HIIT cycle ]
    S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score decribes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

  10. MMSE - Mini Mental State Examination [ Time Frame: Baseline ]
    MMSE will be used to to exclude the Parkinson's disease patients with cognitive impairment, expressed in [points]in the range from 0 to 30 points. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. A score of 23 or lower is indicative of cognitive impairment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • for PD patients: age 55-75 years-old; diagnosis of idiopathic PD; and modified Hoehn and Yahr stages between 1.5 and 3
  • for healthy controls: lack of neurological disorders

Exclusion Criteria:

  • for PD patients: (i) 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 physical activity except for physical therapy for PD
  • for healthy controls: presence of neurological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753503


Sponsors and Collaborators
University School of Physical Education in Wroclaw
Wroclaw Medical University
University School of Physical Education, Krakow, Poland
Investigators
Layout table for investigator information
Principal Investigator: Jarosław Marusiak, PhD University School of Physical Education in Wroclaw
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Jaroslaw Marusiak, Principal Investigator, University School of Physical Education in Wroclaw
ClinicalTrials.gov Identifier: NCT03753503    
Other Study ID Numbers: 0247/p01/2010/70
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaroslaw Marusiak, University School of Physical Education in Wroclaw:
Parkinson's disease
intensive interval training
motor function
executive function
neuroplasticity
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases