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Single Exercise Bout in Parkinson's Disease (PD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
cycling exercise
Sponsored by
Pacific Parkinson's Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring exercise, EEG, EMG, Motor function, Mood, Cognition

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Parkinson's Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parkinson's disease

Control

Arm Description

Subjects with Parkinson's disease

Subjects without Parkinson's disease

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Motor function
Examine motor function with the Movement disorders society unified Parkinson's disease rating scale motor section (MDS-UPDRS III)
Motor function
Examine motor function with the finger tapping
Motor function
Examine motor function with the Purdue pegboard
Motor function
Examine motor function with the Timed-up-and-go (TUG)
Cognitive function
Examine cognitive function with Montreal cognitive assessment (MoCA)
Cognitive function
Examine cognitive function with Verbal fluency
Cognitive function
Examine cognitive function with trail making test (A and B) and reaction time
Mood function
Examine mood with the Positive and Negative Affect Schedule.
Mood function
Examine mood with the Starkein Apathy scale

Full Information

First Posted
February 18, 2017
Last Updated
March 2, 2020
Sponsor
Pacific Parkinson's Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03337464
Brief Title
Single Exercise Bout in Parkinson's Disease (PD)
Official Title
The Effects of a Single Bout of Exercise in Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2013 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Parkinson's Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
exercise, EEG, EMG, Motor function, Mood, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 PD group and 1 one age matched non-PD subjects
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to subject group and intervention.
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease
Arm Type
Experimental
Arm Description
Subjects with Parkinson's disease
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects without Parkinson's disease
Intervention Type
Other
Intervention Name(s)
cycling exercise
Intervention Description
5 x 3 minute bouts of cycling exercise separated by 3 minute rest periods
Primary Outcome Measure Information:
Title
EEG-EMG coherence
Description
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 Outcome Measure Information:
Title
Motor function
Description
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.
Title
Motor function
Description
Examine motor function with the finger tapping
Time Frame
Immediately before and after the single bout of exercise.
Title
Motor function
Description
Examine motor function with the Purdue pegboard
Time Frame
Immediately before and after the single bout of exercise.
Title
Motor function
Description
Examine motor function with the Timed-up-and-go (TUG)
Time Frame
Immediately before and after the single bout of exercise.
Title
Cognitive function
Description
Examine cognitive function with Montreal cognitive assessment (MoCA)
Time Frame
Immediately before, after and at 3 hours following the single bout of exercise.
Title
Cognitive function
Description
Examine cognitive function with Verbal fluency
Time Frame
Immediately before, after and at 3 hours following the single bout of exercise.
Title
Cognitive function
Description
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.
Title
Mood function
Description
Examine mood with the Positive and Negative Affect Schedule.
Time Frame
Immediately before, after and at 3 hours following the single bout of exercise.
Title
Mood function
Description
Examine mood with the Starkein Apathy scale
Time Frame
Immediately before, after and at 3 hours following the single bout of exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silke Cresswell, MD
Organizational Affiliation
Pacific Parkinson's Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Parkinson's Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Single Exercise Bout in Parkinson's Disease (PD)

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