Parkinson DiseaseNCT04189887
Single Bout Exercise on Learning in PD
An observational study of Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Parkinson's disease (PD) is a neurodegenerative disorder associated with a loss of dopamine in the basal ganglia and is characterized by several cardinal motor signs. In addition to the commonly recognized motor symptoms, cognitive impairments are also often observed in people with PD. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- aerobic exercise (cycling) and Implicit sequence learning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2019to 31 Dec 2022
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants diagnosed of idiopathic PD and non-disabled age-matched controls will be recruited.
Who may be able to join
- 1) able to follow instructions to perform the tasks
- 2) without other neurological disorders in addition to PD
- 3) no surgery or injury of the upper extremities in recent 6 months
Who cannot join
- 1) deep brain stimulation or pacemaker implanted
- 2) a self-history of seizure
- 3) unstable medical conditions
- 4) a blood-relative with a history of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Single Bout of Aerobic Exercise on Implicit Sequence Learning in People With Parkinson's Disease
Parkinson's disease (PD) is a neurodegenerative disorder associated with a loss of dopamine in the basal ganglia and is characterized by several cardinal motor signs. In addition to the commonly recognized motor symptoms, cognitive impairments are also often observed in people with PD. Unlike motor deficits, cognitive impairments are not always responsive to dopaminergic treatment. While medication may ameliorate some cognitive dysfunctions (e.g., executive function), it may exacerbate others (e.g., motor learning). Therefore, it is crucial for clinicians to look for treatment approaches, other than medication, to enhance cognitive function. In this proposed study, the investigators are especially interested in determining a method to enhance motor learning ability in people with PD.
Motor learning deficits in people with PD have been well established through different tasks including motor adaptation task such as maintain balance on a stabilometer or motor sequence task such as performing a serial reaction time task (SRTT). Motor sequence learning is important in acquiring real-life motor skill such as tying shoes laces. Based on the past evidences, people with PD have impairments in motor sequence learning, particularly in implicit sequence learning. Since implicit motor sequence learning constitutes a critical part of everyday activities such as typing and changing clothes, establishing an approach to enhance implicit sequence learning is important.
In the literature conducted with non-disable adults, one of the most effective method to enhance motor learning is aerobic exercise. Only one study, to the best of knowledge, has investigated the effect of aerobic exercise on learning to maintain balance on a stabilometer in people with PD. To date, no study has investigated whether a single bout of aerobic exercise could improve implicit sequence learning in PD. Therefore, the goal of this proposed study is to investigate the effect of a single bout of aerobic exercise on implicit sequence learning and the associated neurophysiological changes in people with PD.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative disorder associated with loss of dopamine in the basal ganglia and is characterized by several cardinal motor signs, such as tremor, rigidity, bradykinesia, and postural instability. In addition to the commonly recognized motor symptoms, non-motor symptoms such as olfactory dysfunction, emotional issues, autonomic dysfunction and cognitive impairments are also often observed in people with PD. Among these non-motor symptoms, cognitive dysfunction is the most disturbing deficit and can hugely affect an individual's daily activity. Unlike motor deficits, these cognitive impairments are not always responsive to dopaminergic treatment. While medication may ameliorate some cognitive dysfunctions (e.g., executive function), it may exacerbate others (e.g., motor learning).Therefore, it is crucial for clinicians to look for treatment approaches, other than medication, to enhance cognitive function . In this proposed study, the investigators are especially interested in determining a method to enhance motor learning ability and reduce motor learning deficit in people with PD as motor learning is a crucial basis in learning new skills and optimizing activities of daily living.
Motor learning deficits in people with PD have been well established through different tasks including motor adaptation task such as maintain balance on a stabilometer or motor sequence task such as performing a serial reaction time task (SRTT). Motor sequence learning is important in acquiring real-life motor skill such as tying shoes laces and using chopsticks. There are two types of experiment paradigms to assess motor sequence learning, they are implicit sequence task and explicit sequence task. Compared with age-matched non-disable adults, people with PD demonstrated different level of impairments in learning those tasks. In this study, the investigators will especially focus on the impairment in motor sequence learning in people with PD. Based on the evidences, implicit sequence learning is more affected in people in PD compared to explicit sequence learning. Since implicit motor sequence learning constitutes a critical part of everyday activities such as typing and changing clothes, therefore the investigators are more interested in exploring implicit sequence learning in people with PD.
As previously reviewed, motor learning dysfunction could not be ameliorated by dopaminergic intake, thus several researchers aimed to find alternative method to improve motor learning ability. In the literature conducted with non-disable adults, one of the most effective method to enhance motor learning is aerobic exercise.7 Rhee et al. (2016) conducted a study and showed that a single bout of 20 minutes high intensity aerobic exercise can improve the performance of a finger sequence learning task in non-disable adults. Only one study, to the best of our knowledge, has investigated the effect of aerobic exercise on learning to maintain balance on a stabilometer in people with PD. The participants with PD were required to perform a single bout of 30-minute moderate intensity (60-70% VO2max) cycling exercise before practicing the stabilometer task. Their results found that compared to the non-aerobic condition, 30 minutes of aerobic exercise led to great improvements in motor performance at retention. However, there are some limitations of this study which may influence the result. First of all, 30 minutes of aerobic exercise before skill learning might be too fatiguing for people with PD, and might compromise subsequent practice of the stabilometer task. Furthermore, the authors found improvements in maintaining balance on a stabilometer but the related neurophysiological changes have not been determined. Therefore, the goal of this proposed study is to modify the above limitations and to conduct a study to investigate the effect of a single bout of aerobic exercise to implicit sequence learning and the related neurophysiological changes in people with PD. More importantly, the investigatorse would like to investigate whether corticomotor excitability will change along with motor learning improvement in people with PD.
The purpose of this proposed study is to explore whether a single-bout aerobic exercise could enhance implicit motor sequence learning in people with PD. Moreover, the neurophysiological changes associated with aerobic exercise and learning will be determined.
- Conditions
- Parkinson Disease
- Being tested
- aerobic exercise (cycling), Implicit sequence learning
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise (cycling)Behavioural
People who perform aerobic exercise will ride on a stationary bike for 20 minutes after motor skill learning
Implicit sequence learningBehavioural
Also called serial reaction time task (SRTT)
All participants will practice the serial reaction time task (SRTT) on the first day, and retention performance will be assessed immediately, on the 2nd day, and on the 7th day of study.
| Study group | Role | What they receive |
|---|---|---|
| PD+AEX | The group of people with PD which will perform aerobic exercise after motor skill acquisition Receives: Behavioral: aerobic exercise (cycling); Behavioral: Implicit sequence learning | |
| PD-AEX | The group of people with PD which will not perform aerobic exercise after motor skill acquisition Receives: Behavioral: Implicit sequence learning | |
| CON+AEX | The group of control participants which will perform aerobic exercise after motor skill acquisition Receives: Behavioral: aerobic exercise (cycling); Behavioral: Implicit sequence learning | |
| CON-AEX | The group of control participants which will not perform aerobic exercise after motor skill acquisition Receives: Behavioral: Implicit sequence learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the sequence learning task
A serial reaction time task (SRTT) will be used to determine the sequence learning ability. At the beginning of the SRTT, only one circle will be filled with color while others remain hollow. Once the participants hit the correct button, the next target will appear. Unknown to the participants, an 12-element sequence is embedded within the random sequences. The response time of the key presses of the embedded sequence will be recorded. The change score will be calculated between the 1st and 2nd sessions, and between the 1st and 7th sessions.
Measured: 30 minutes
Secondary outcomes (1)
Corticomotor excitability
Transcranial magnetic stimulation (TMS) will be used to evaluate corticomotor excitability. Corticomotor excitability outcomes will include motor evoke potential (MEP), cortical silent period (CSP) duration, short-interval intracortical inhibition (SICI), intracortical facilitation (ICF), and long-interval intracortical inhibition (LICI). The RMT could reflect the membrane excitability of the corticospinal neurons and the cortical interneurons. Peak-to-peak MEP amplitude is an indicator of the integrity and excitability of the corticospinal tract. The CSP is a period when EMG activity being suppressed for a few hundred milliseconds after the MEP, and has often been used as an indicator of the inhibitory mechanism occurs within the corticospinal tract. The SICI, ICF, and LICI have been identified to be good indicators of intracortical inhibition and facilitation.
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start27 Nov 2019
- Primary completion26 Sep 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Yun Lee, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189887
- Sponsor's protocol ID
- 20190901RINC
- Status last verified
- Jul 2022
- First submitted
- 27 Nov 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan ST, Tai CH, Wang LY, Luh JJ, Lee YY. Influences of Aerobic Exercise on Motor Sequence Learning and Corticomotor Excitability in People With Parkinson's Disease. Neurorehabil Neural Repair. 2023 Jan;37(1):37-45. doi: 10.1177/15459683221147006. Epub 2023 Jan 12.
PubMed 36636767
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Bout of Aerobic Exercise on Implicit Sequence Learning in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04189887
- Acronym / sponsor ID
- 20190901RINC
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Dec 2019 (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.
Parkinson's disease (PD) is a neurodegenerative disorder associated with a loss of dopamine in the basal ganglia and is characterized by several cardinal motor signs. In addition to the commonly recognized motor symptoms, cognitive impairments are also often observed in people with PD. Unlike motor deficits, cognitive impairments are not always responsive to dopaminergic treatment. While medication may ameliorate some cognitive dysfunctions (e.g., executive function), it may exacerbate others (e.g., motor learning). Therefore, it is crucial for clinicians to look for treatment approaches, other than medication, to enhance cognitive function. In this proposed study, the investigators are especially interested in determining a method to enhance motor learning ability in people with PD.
Motor learning deficits in people with PD have been well established through different tasks including motor adaptation task such as maintain balance on a stabilometer or motor sequence task such as performing a serial reaction time task (SRTT). Motor sequence learning is important in acquiring real-life motor skill such as tying shoes laces. Based on the past evidences, people with PD have impairments in motor sequence learning, particularly in implicit sequence learning. Since implicit motor sequence learning constitutes a critical part of everyday activities such as typing and changing clothes, establishing an approach to enhance implicit sequence learning is important.
In the literature conducted with non-disable adults, one of the most effective method to enhance motor learning is aerobic exercise. Only one study, to the best of knowledge, has investigated the effect of aerobic exercise on learning to maintain balance on a stabilometer in people with PD. To date, no study has investigated whether a single bout of aerobic exercise could improve implicit sequence learning in PD. Therefore, the goal of this proposed study is to investigate the effect of a single bout of aerobic exercise on implicit sequence learning and the associated neurophysiological changes in people with PD.
Detailed description
Parkinson's disease (PD) is a neurodegenerative disorder associated with loss of dopamine in the basal ganglia and is characterized by several cardinal motor signs, such as tremor, rigidity, bradykinesia, and postural instability. In addition to the commonly recognized motor symptoms, non-motor symptoms such as olfactory dysfunction, emotional issues, autonomic dysfunction and cognitive impairments are also often observed in people with PD. Among these non-motor symptoms, cognitive dysfunction is the most disturbing deficit and can hugely affect an individual's daily activity. Unlike motor deficits, these cognitive impairments are not always responsive to dopaminergic treatment. While medication may ameliorate some cognitive dysfunctions (e.g., executive function), it may exacerbate others (e.g., motor learning).Therefore, it is crucial for clinicians to look for treatment approaches, other than medication, to enhance cognitive function . In this proposed study, the investigators are especially interested in determining a method to enhance motor learning ability and reduce motor learning deficit in people with PD as motor learning is a crucial basis in learning new skills and optimizing activities of daily living.
Motor learning deficits in people with PD have been well established through different tasks including motor adaptation task such as maintain balance on a stabilometer or motor sequence task such as performing a serial reaction time task (SRTT). Motor sequence learning is important in acquiring real-life motor skill such as tying shoes laces and using chopsticks. There are two types of experiment paradigms to assess motor sequence learning, they are implicit sequence task and explicit sequence task. Compared with age-matched non-disable adults, people with PD demonstrated different level of impairments in learning those tasks. In this study, the investigators will especially focus on the impairment in motor sequence learning in people with PD. Based on the evidences, implicit sequence learning is more affected in people in PD compared to explicit sequence learning. Since implicit motor sequence learning constitutes a critical part of everyday activities such as typing and changing clothes, therefore the investigators are more interested in exploring implicit sequence learning in people with PD.
As previously reviewed, motor learning dysfunction could not be ameliorated by dopaminergic intake, thus several researchers aimed to find alternative method to improve motor learning ability. In the literature conducted with non-disable adults, one of the most effective method to enhance motor learning is aerobic exercise.7 Rhee et al. (2016) conducted a study and showed that a single bout of 20 minutes high intensity aerobic exercise can improve the performance of a finger sequence learning task in non-disable adults. Only one study, to the best of our knowledge, has investigated the effect of aerobic exercise on learning to maintain balance on a stabilometer in people with PD. The participants with PD were required to perform a single bout of 30-minute moderate intensity (60-70% VO2max) cycling exercise before practicing the stabilometer task. Their results found that compared to the non-aerobic condition, 30 minutes of aerobic exercise led to great improvements in motor performance at retention. However, there are some limitations of this study which may influence the result. First of all, 30 minutes of aerobic exercise before skill learning might be too fatiguing for people with PD, and might compromise subsequent practice of the stabilometer task. Furthermore, the authors found improvements in maintaining balance on a stabilometer but the related neurophysiological changes have not been determined. Therefore, the goal of this proposed study is to modify the above limitations and to conduct a study to investigate the effect of a single bout of aerobic exercise to implicit sequence learning and the related neurophysiological changes in people with PD. More importantly, the investigatorse would like to investigate whether corticomotor excitability will change along with motor learning improvement in people with PD.
The purpose of this proposed study is to explore whether a single-bout aerobic exercise could enhance implicit motor sequence learning in people with PD. Moreover, the neurophysiological changes associated with aerobic exercise and learning will be determined.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD+AEX | – | Behavioral: aerobic exercise (cycling), Behavioral: Implicit sequence learningThe group of people with PD which will perform aerobic exercise after motor skill acquisition |
| PD-AEX | – | Behavioral: Implicit sequence learningThe group of people with PD which will not perform aerobic exercise after motor skill acquisition |
| CON+AEX | – | Behavioral: aerobic exercise (cycling), Behavioral: Implicit sequence learningThe group of control participants which will perform aerobic exercise after motor skill acquisition |
| CON-AEX | – | Behavioral: Implicit sequence learningThe group of control participants which will not perform aerobic exercise after motor skill acquisition |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed of idiopathic PD and non-disabled age-matched controls will be recruited.
Key inclusion criteria (3 listed)
- 1) able to follow instructions to perform the tasks
- 2) without other neurological disorders in addition to PD
- 3) no surgery or injury of the upper extremities in recent 6 months
Key exclusion criteria (4 listed)
- 1) deep brain stimulation or pacemaker implanted
- 2) a self-history of seizure
- 3) unstable medical conditions
- 4) a blood-relative with a history of epilepsy
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 |
|---|---|---|
| aerobic exercise (cycling)People who perform aerobic exercise will ride on a stationary bike for 20 minutes after motor skill learning | Behavioural | CON+AEX, PD+AEX |
| Implicit sequence learningAlso: serial reaction time task (SRTT)All participants will practice the serial reaction time task (SRTT) on the first day, and retention performance will be assessed immediately, on the 2nd day, and on the 7th day of study. | Behavioural | CON+AEX, CON-AEX, PD+AEX, PD-AEX |
Primary outcome
Performance of the sequence learning task
Time frame: 30 minutes
A serial reaction time task (SRTT) will be used to determine the sequence learning ability. At the beginning of the SRTT, only one circle will be filled with color while others remain hollow. Once the participants hit the correct button, the next target will appear. Unknown to the participants, an 12-element sequence is embedded within the random sequences. The response time of the key presses of the embedded sequence will be recorded. The change score will be calculated between the 1st and 2nd sessions, and between the 1st and 7th sessions.
1 secondary outcome
Corticomotor excitability
Time frame: 50 minutes
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 Mar 2023.
- Derived from this study: PubMed 36636767Chan ST, Tai CH, Wang LY, Luh JJ, Lee YY. Influences of Aerobic Exercise on Motor Sequence Learning and Corticomotor Excitability in People With Parkinson's Disease. Neurorehabil Neural Repair. 2023 Jan;37(1):37-45. doi: 10.1177/15459683221147006. Epub 2023 Jan 12.
- 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.
Ya-Yun Lee principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Performance of the sequence learning task (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189887, which also lists 1 linked publication.
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 Mar 2023.