NCT04189887

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 28, 2023

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

November 27, 2019

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 minutes

Secondary Outcomes (1)

  • Corticomotor excitability

    50 minutes

Other Outcomes (5)

  • Montreal Cognitive Assessment

    10 minutes

  • Stroop test

    5 minutes

  • The Trail Making test

    5 minutes

  • +2 more other outcomes

Study Arms (4)

PD+AEX

The group of people with PD which will perform aerobic exercise after motor skill acquisition

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

Behavioral: Implicit sequence learning

CON+AEX

The group of control participants which will perform aerobic exercise after motor skill acquisition

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

Behavioral: Implicit sequence learning

Interventions

People who perform aerobic exercise will ride on a stationary bike for 20 minutes after motor skill learning

CON+AEXPD+AEX

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.

Also known as: serial reaction time task (SRTT)
CON+AEXCON-AEXPD+AEXPD-AEX

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed of idiopathic PD and non-disabled age-matched controls will be recruited.

You may qualify if:

  • \) able to follow instructions to perform the tasks
  • \) without other neurological disorders in addition to PD
  • \) no surgery or injury of the upper extremities in recent 6 months

You may not qualify if:

  • \) deep brain stimulation or pacemaker implanted
  • \) a self-history of seizure
  • \) unstable medical conditions
  • \) a blood-relative with a history of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongcheng, 100, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ya-Yun Lee

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 6, 2019

Study Start

November 27, 2019

Primary Completion

September 26, 2020

Study Completion

December 31, 2022

Last Updated

March 28, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations