NCT03337464

Brief Summary

To assess 30 active people (15 with PD, 15 without) before and after 30 minutes of pedaling exercise using EEG-EMG, cognitive, mood and motor assessments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2013

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

Study Start

First participant enrolled

April 2, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

February 18, 2017

Last Update Submit

March 2, 2020

Conditions

Keywords

exerciseEEGEMGMotor functionMoodCognition

Outcome Measures

Primary Outcomes (1)

  • EEG-EMG coherence

    Coherence of the coupling between EEG and EMG from active leg muscles during cycling on a stationary bicycle both in subjects with PD and age and gender matched healthy controls.

    The change from immediately before, during, and immediatly after the single bout of exercise.

Secondary Outcomes (9)

  • Motor function

    Immediately before and after the single bout of exercise.

  • Motor function

    Immediately before and after the single bout of exercise.

  • Motor function

    Immediately before and after the single bout of exercise.

  • Motor function

    Immediately before and after the single bout of exercise.

  • Cognitive function

    Immediately before, after and at 3 hours following the single bout of exercise.

  • +4 more secondary outcomes

Study Arms (2)

Parkinson's disease

EXPERIMENTAL

Subjects with Parkinson's disease

Other: cycling exercise

Control

ACTIVE COMPARATOR

Subjects without Parkinson's disease

Other: cycling exercise

Interventions

5 x 3 minute bouts of cycling exercise separated by 3 minute rest periods

ControlParkinson's disease

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult between 40-80 years
  • Hoehn and Yahr stage I-III
  • Exercise on a regular basis (at least 100 minutes of aerobic exercise per week)
  • Montreal Cognitive Assessment score \>/= 24
  • Able to communicate with study personnel
  • Able to be informed of the nature of the study and willing to give written consent form

You may not qualify if:

  • Hoehn and Yahr stages IV-V
  • Significant cardiovascular disease
  • Previous stroke
  • Not exercising on a regular basis
  • Functional disabling dyskinesia
  • Functional disabling dystonia
  • Smoker
  • Significant neurological or psychiatric illness other than PD
  • Dementia
  • Severe depression
  • Significant musculoskeletal disorder (e.g. arthritis)
  • Significant metabolic disorder (e.g. diabetes)
  • Brain surgery in the past
  • Currently taking beta blocker medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Silke Cresswell, MD

    Pacific Parkinson's Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will be blinded to subject group and intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1 PD group and 1 one age matched non-PD subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of PET

Study Record Dates

First Submitted

February 18, 2017

First Posted

November 9, 2017

Study Start

April 2, 2013

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations