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Completed

NCT Number: NCT03337464

Single Exercise Bout in Parkinson's Disease (PD)

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

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

Treatment and study plan

cycling exercise

Other

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

Primary outcomes

  1. EEG-EMG coherence

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

    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.

Secondary outcomes

  1. Motor function

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

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

  2. Motor function

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

    Examine motor function with the finger tapping

  3. Motor function

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

    Examine motor function with the Purdue pegboard

  4. Motor function

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

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

  5. Cognitive function

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

    Examine cognitive function with Montreal cognitive assessment (MoCA)

  6. Cognitive function

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

    Examine cognitive function with Verbal fluency

  7. Cognitive function

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

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

  8. Mood function

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

    Examine mood with the Positive and Negative Affect Schedule.

  9. Mood function

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

    Examine mood with the Starkein Apathy scale

Sponsors and collaborators

Lead sponsor

Pacific Parkinson's Research Centre

Other

Registry information

Official study title

The Effects of a Single Bout of Exercise in Parkinson's Disease.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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