Parkinson DiseaseNCT03337464
Single Exercise Bout in Parkinson's Disease (PD)
A study testing cycling exercise in people with Parkinson Disease, run by Pacific Parkinson's Research Centre at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- cycling exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2013to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hoehn and Yahr stages IV-V
- Significant cardiovascular disease
- Previous stroke
- Not exercising on a regular basis
- Functional disabling dyskinesia
- Functional disabling dystonia
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6T 2B5
About this study
Official title: The Effects of a Single Bout of Exercise in Parkinson's Disease.
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.
- Conditions
- Parkinson Disease
- Being tested
- cycling exercise
- Keywords
- exercise, EEG, EMG, Motor function, Mood, Cognition
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cycling exerciseOther
5 x 3 minute bouts of cycling exercise separated by 3 minute rest periods
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Experimental | Subjects with Parkinson's disease Receives: Other: cycling exercise |
| Control | Active comparator | Subjects without Parkinson's disease Receives: Other: cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The change from immediately before, during, and immediatly after the single bout of exercise.
Secondary outcomes (9)
Motor function
Examine motor function with the Movement disorders society unified Parkinson's disease rating scale motor section (MDS-UPDRS III)
Measured: Immediately before and after the single bout of exercise.
Motor function
Examine motor function with the finger tapping
Measured: Immediately before and after the single bout of exercise.
Motor function
Examine motor function with the Purdue pegboard
Measured: Immediately before and after the single bout of exercise.
Motor function
Examine motor function with the Timed-up-and-go (TUG)
Measured: Immediately before and after the single bout of exercise.
Cognitive function
Examine cognitive function with Montreal cognitive assessment (MoCA)
Measured: Immediately before, after and at 3 hours following the single bout of exercise.
Cognitive function
Examine cognitive function with Verbal fluency
Measured: Immediately before, after and at 3 hours following the single bout of exercise.
Cognitive function
Examine cognitive function with trail making test (A and B) and reaction time
Measured: Immediately before, after and at 3 hours following the single bout of exercise.
Mood function
Examine mood with the Positive and Negative Affect Schedule.
Measured: Immediately before, after and at 3 hours following the single bout of exercise.
Mood function
Examine mood with the Starkein Apathy scale
Measured: Immediately before, after and at 3 hours following the single bout of exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start2 Apr 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1 PD group and 1 one age matched non-PD subjects
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Parkinson's Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Jon Stoessl, Pacific Parkinson's Research Centre
- Investigators
- Silke Cresswell, MD, Principal investigator, Pacific Parkinson's Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337464
- Sponsor's protocol ID
- H13-00084
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Bout of Exercise in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03337464
- Acronym / sponsor ID
- H13-00084
- Conditions
- Parkinson Disease
- Keywords
- exercise, EEG, EMG, Motor function, Mood, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pacific Parkinson's Research CentreUniversity, hospital or other
- Study start
- 2 Apr 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1 PD group and 1 one age matched non-PD subjects
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | Experimental | Other: cycling exerciseSubjects with Parkinson's disease |
| Control | Active comparator | Other: cycling exerciseSubjects without Parkinson's disease |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Hoehn and Yahr stages IV-V
- Significant cardiovascular disease
- Previous stroke
- Not exercising on a regular basis
- Functional disabling dyskinesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cycling exercise5 x 3 minute bouts of cycling exercise separated by 3 minute rest periods | Other | Control, Parkinson's disease |
Primary outcome
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.
9 secondary outcomes
Motor function
Time frame: Immediately before and after the single bout of exercise.
Motor function
Time frame: Immediately before and after the single bout of exercise.
Motor function
Time frame: Immediately before and after the single bout of exercise.
Motor function
Time frame: Immediately before and after the single bout of exercise.
Cognitive function
Time frame: Immediately before, after and at 3 hours following the single bout of exercise.
Cognitive function
Time frame: Immediately before, after and at 3 hours following the single bout of exercise.
Cognitive function
Time frame: Immediately before, after and at 3 hours following the single bout of exercise.
Mood function
Time frame: Immediately before, after and at 3 hours following the single bout of exercise.
Mood function
Time frame: Immediately before, after and at 3 hours following the single bout of exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Cresswell, MD principal investigator
Pacific Parkinson's Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cycling exercise in people with Parkinson Disease, run by Pacific Parkinson's Research Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG-EMG coherence (time frame: The change from immediately before, during, and immediatly after the single bout of exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.