ClinicalTrials.gg
CompletedNCT03337464Updated Mar 4, 2020

Single Exercise Bout in Parkinson's Disease (PD)

An interventional study of cycling exercise in Parkinson Disease, sponsored by Pacific Parkinson's Research Centre. Completed at 1 site in Canada. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Pacific Parkinson's Research Centre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Apr 2013, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 253 studies in Parkinson Disease with a site in Canada — 43 open to participants now, 62 under way, 3 of them phase 3. Parkinson Disease · Canada.

Enrollment
162nd of 212
23 · median 60
Started
2013
with 9 others
No phase
95 of 253
24 open now
Registered
122nd of 253
by date
Lead sponsor
7 of 253
Pacific Parkinson's Research Centre

Among the 253 studies in Parkinson Disease with a site in Canada, this one is the 162nd largest by enrollment of the 212 interventional ones that give a count, is one of 10 that started in 2013, is one of 95 with no phase, and was the 122nd registered.

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

43 of the 253 studies in Parkinson Disease with a site in Canada are open now. Recruiting first, the newest first:

38 more — sign in →

All 43 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

Purpose: To assess 15 subjects with PD and 15 healthy controls, who exercise on a regular basis, before, during and after 30 minutes of pedaling exercise intervention. The investigators will assess subjects for alterations in motor cortex assessment, cognition and mood as measured by EMG/EEG, motor assessment and several batteries of questionnaires. Findings from this study will lay the foundation for long-term studies.

Hypotheses: The investigators anticipate to observe an altered involvement of motor cortex during steady pedaling in individuals suffering from PD. In healthy control subjects it is anticipated that changes in cognition will be observable.

Justification: Hindered movement initiation and continuing locomotion is a common syndrome in PD with profound impact on the patient's mobility and quality of life. So far, the underlying pathophysiology is not completely understood. Since the observation that cortical activity contributes to the muscle activity during locomotion-like tasks underpins the importance of corticospinal function in humans, it is of importance to examine whether this cortical involvement is altered and displays abnormalities in patients with PD. Thus, the approach of corticomuscular coupling during a locomotion-like task would allow for better understanding of the pathophysiology of PD, a prerequisite to develop therapies. Findings of this study will lay the foundation for future long-term studies.

Additionally, by examining the oscillatory EEG patterns during the exercise intervention, the investigator will be able to read out the dose response curve in real time, which will provide information on the optimum intensity and duration of exercise. Findings will help to design future studies and to develop efficient exercise therapy interventions for people with PD.

People living with PD often suffer from cognitive decline, depression, and fatigue. By assessing cognitive function before and after the exercise intervention, there will be laid a foundation for future studies investigating the effect of exercise on cognition. The collected pilot data will be relevant to learn more about the effects of exercise on mood and fatigue as well as concomitant obstacles and facilitators during exercise interventions in patients with PD.

Objectives: The primary objective of this study is to investigate if activity that arises in the motor cortex and contributes to the muscle activity during moderate pedaling is altered in patients with PD compared to healthy gender- and age-matched controls. Thus, to better understand the role of the motor cortex and its contribution in simple automated repetitive tasks in patients with PD there will be analysis of the 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.

03

Conditions studied

  • Parkinson Disease

Keywords

  • exercise
  • EEG
  • EMG
  • Motor function
  • Mood
  • Cognition
04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Parkinson's disease

    Subjects with Parkinson's disease

    Other: cycling exercise

  • Active comparator
    Control

    Subjects without Parkinson's disease

    Other: cycling exercise

Interventions

  • Othercycling exercise

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Motor function

    Examine motor function with the Movement disorders society unified Parkinson's disease rating scale motor section (MDS-UPDRS III)

    Time frame: Immediately before and after the single bout of exercise.

  2. Motor function

    Examine motor function with the finger tapping

    Time frame: Immediately before and after the single bout of exercise.

  3. Motor function

    Examine motor function with the Purdue pegboard

    Time frame: Immediately before and after the single bout of exercise.

  4. Motor function

    Examine motor function with the Timed-up-and-go (TUG)

    Time frame: Immediately before and after the single bout of exercise.

  5. Cognitive function

    Examine cognitive function with Montreal cognitive assessment (MoCA)

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

  6. Cognitive function

    Examine cognitive function with Verbal fluency

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

  7. Cognitive function

    Examine cognitive function with trail making test (A and B) and reaction time

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

  8. Mood function

    Examine mood with the Positive and Negative Affect Schedule.

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

  9. Mood function

    Examine mood with the Starkein Apathy scale

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

07

Study locations

1 site
  • Pacific Parkinson's Research Centre
    Vancouver, British Columbia V6T 2B5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2013 to primary completion in Dec 2014, 20 months.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 20 months is below that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2017
First posted
Nov 9, 2017
StartActual
Apr 2, 2013
Primary completionActual
Dec 31, 2014
CompletionActual
Dec 31, 2014
Last update
Mar 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03337464
Lead sponsor
Pacific Parkinson's Research Centre
Responsible party
A. Jon Stoessl (Clinical Director of PET, Pacific Parkinson's Research Centre) — Principal investigator
First posted
Nov 9, 2017
Start date
Apr 2, 2013
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014
Last update
Mar 4, 2020

Study contacts

Silke Cresswell, MD
principal investigator · Pacific Parkinson's Research Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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