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

NCT03753503 | Completed

• 1 other identifier: 0247/p01/2010/70
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Physical Activity

Keywords

Parkinson's disease; intensive interval training; motor function; executive function; neuroplasticity

Outcome Measures

Primary Outcomes (33)

• Electroencephalography (EEG) - electrical activity 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 64-chanel system. The recordings will be conducted during bimanual motor tasks and at rest. The recordings will be expressed in microvolts \[µV\].

  Baseline

• Electroencephalography (EEG) - electrical activity 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 64-chanel system. The recordings will be conducted during bimanual motor tasks and at rest. The recordings will be expressed in microvolts \[µV\].

  1-week-post HIIT cycle

• Electroencephalography (EEG) - electrical activity 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 64-chanel system. The recordings will be conducted during bimanual motor tasks and at rest. The recordings will be expressed in microvolts \[µV\].

  1-month-post HIIT cycle

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

  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 \[mV\].

  Baseline

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

  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 \[mV\].

  1-week-post HIIT cycle

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

  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 \[mV\].

  1-month-post HIIT cycle

• BDNF - brain derived neurotrophic factor

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

  Baseline

• BDNF - brain derived neurotrophic factor

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

  1-week-post HIIT cycle

• BDNF - brain derived neurotrophic factor

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

  1-month-post HIIT cycle

• NGF - nerve growth factor

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

  Baseline

• NGF - nerve growth factor

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

  1-week-post HIIT cycle

• NGF - nerve growth factor

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

  1-month-post HIIT cycle

• IGF 1 - insulin-like growth factor 1

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

  Baseline

• IGF 1 - insulin-like growth factor 1

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

  1-week-post HIIT cycle

• IGF 1 - insulin-like growth factor 1

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

  1-month-post HIIT cycle

• Force measurements of both hands' index fingers motor control

  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 \[N/s\].

  Baseline

• Force measurements of both hands' index fingers motor control

  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 \[N/s\].

  1-week-post HIIT cycle

• Force measurements of both hands' index fingers motor control

  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 \[N/s\].

  1-month-post HIIT cycle

• Force measurements of bimanual dexterity function

  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 \[N/s\].

  Baseline

• Force measurements of bimanual dexterity function

  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 \[N/s\].

  1-week-post HIIT cycle

• Force measurements of bimanual dexterity function

  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 \[N/s\].

  1-month-post HIIT cycle

• 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 \[s\].

  Baseline

• 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 cycle

• 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-month-post HIIT cycle

• 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 \[s\].

  Baseline

• 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 cycle

• 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-month-post HIIT cycle

• 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 \[s\].

  Baseline

• 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 cycle

• 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-month-post HIIT cycle

• 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 \[s\].

  Baseline

• 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 cycle

• 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-month-post HIIT cycle

Secondary Outcomes (10)

• UPDRS - unified Parkinson's disease rating scale

  Baseline

• UPDRS - unified Parkinson's disease rating scale

  1-week-post HIIT cycle

• UPDRS - unified Parkinson's disease rating scale

  1-month-post HIIT cycle

• H&Y scale - Hoehn and Yahr scale

  Baseline

• H&Y scale - Hoehn and Yahr scale

  1-week-post HIIT cycle

Study Arms (3)

PD-TR

EXPERIMENTAL

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

Behavioral: exercise; 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

exercise BEHAVIORAL

exercised three times a week in the 8-week HIIT program

PD-TR

conventional physical therapy BEHAVIORAL

PD-NTR; PD-TR

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Wroclaw Medical University: collaborator
• University School of Physical Education, Krakow, Poland: collaborator

Related Publications (2)

• Marusiak J, Zeligowska E, Mencel J, Kisiel-Sajewicz K, Majerczak J, Zoladz JA, Jaskolski A, Jaskolska A. Interval training-induced alleviation of rigidity and hypertonia in patients with Parkinson's disease is accompanied by increased basal serum brain-derived neurotrophic factor. J Rehabil Med. 2015 Apr;47(4):372-5. doi: 10.2340/16501977-1931.

  PMID: 25510618 BACKGROUND

• Zoladz JA, Majerczak J, Zeligowska E, Mencel J, Jaskolski A, Jaskolska A, Marusiak J. Moderate-intensity interval training increases serum brain-derived neurotrophic factor level and decreases inflammation in Parkinson's disease patients. J Physiol Pharmacol. 2014 Jun;65(3):441-8.

  PMID: 24930517 RESULT

Related Links

• The New York Times article about our findings. Author: Jane E. Brody; Title: Why Your Workout Should Be High-Intensity, autorka: JANE E. BRODY

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jarosław Marusiak, PhD

  Wroclaw University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

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: November 15, 2018
• First Posted: November 27, 2018
• Study Start: November 8, 2012
• Primary Completion: November 9, 2015
• Study Completion: November 9, 2016
• Last Updated: December 3, 2018

Record last verified: 2018-11