Parkinson DiseaseEBEPDNCT04426786
Exercise & Brain Energetics in PD
A study testing Active exercise and Passive exercise in people with Parkinson Disease, run by Pacific Parkinson's Research Centre at 1 site in Canada.
Trial summary
There is increasing evidence that the usage and delivery of energy to the brain, known as brain energetics, is altered in people with Parkinson's disease (PD). This project will explore whether exercise has a positive impact on brain energetics using functional Magnetic Resonance Imaging (fMRI) and Positron Emission… 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?
- Active exercise and Passive exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
- Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
- Currently exercise less than 120 minutes per week (PD non-exercisers)
- General exclusion criteria:
- atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- significant osteoporosis or arthritis;
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- history of cancer within 5 years of study participation;
- high dose of radiation from other procedures within the year;
- not able to tolerate being off PD medication for up to 24 hours;
- a female subject who is breast-feeding or pregnant;
- current or past substance use problems;
- serious head injury with loss of consciousness for ≥ 5 minutes;
- people with other chronic diseases such as diabetes, kidney problems, high blood pressure, other known neurological disorders, or heart diseases;
- people who report having a significant respiratory disorder (e.g. asthma, chronic obstructive pulmonary disease (COPD)) or using home oxygen will be excluded to avoid discomfort or breathing difficulties from respiratory manipulations.
- current or past neurological disorder (e.g. strokes, seizures, neurodegenerative disease other than Parkinson's disease);
- current or past psychiatric disorders (e.g. depression, anxiety disorders);
- severe claustrophobia (a fear of closed in spaces);
- weight of more than 158kg (347 lbs);
- inability to lay still for up to 90 minutes;
- are not medically cleared to exercise;
- certain medications or conditions may impact participant's ability to participate and these will be discussed on a case by case basis with the participant and the study team.
- MRI-specific exclusion criteria:
- Machinist or metalworkers;
- cardiac pacemakers, wires, or defibrillator;
- past injury where a piece of metal lodged in your eye or orbit;
- ferromagnetic aneurysm clip;
- artificial heart valve;
- electrical stimulator for nerves or bones;
- ear or eye implant;
- implanted drug infusion pump;
- coil, catheter, or filter in any blood vessel;
- orthopedic hardware (artificial joint, plate, screws);
- other metallic prostheses;
- shrapnel, bullets, or other metal fragments;
- dentures, braces, or retainer;
- surgery (brain or otherwise), tattoos, or injection into a joint in the last 6 weeks;
- pierced body parts (other than earrings) or tattooed eyeliner;
- non-MRI safe intrauterine device (IUD).
- Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:
- significant cognitive impairment or depression;
- significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening aerobic exercise test;
- failure to comply with the exercise intervention program by not completing at least 60 of the 72 exercise classes.
Who cannot join
None listed.
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 Effect of Exercise on Brain Energetics in Parkinson's Disease
There is increasing evidence that the usage and delivery of energy to the brain, known as brain energetics, is altered in people with Parkinson's disease (PD). This project will explore whether exercise has a positive impact on brain energetics using functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) brain scanning in PD subjects.
PD subjects will be scanned before and after a supervised exercise program to investigate the effect of exercise on brain energetics. In a separate study, the investigators will also scan healthy volunteers to compare brain energetics in the healthy brain with the brain energetics data in PD subjects acquired in this study.
Read the detailed description
Previous work has investigated the link between decreased brain energetics (through mitochondrial dysfunction), though an investigation in-vivo has never been feasible due to technology constraints. Furthermore, recent work has suggested exercise may help reduce the effect of mitochondrial dysfunction. There is thus compelling evidence to investigate brain energetics/mitochondrial function in-vivo, in health, at different stages of disease and the relationship to exercise. While such measurements are intrinsically difficult, a useful measure is expected to be derived from the ratio between the cerebral metabolic rate of oxygen (CMRO2) and the cerebral metabolic rate of glucose (CMRGlu), if they are measured simultaneously. The simultaneous aspect of the two measurements is extremely important as diurnal variations in CMRO2 can be as high as 20%, while those in CMRGlu as high as 38%. Fortunately, given recent advances in measurement technique and instrumentation development, such studies are now becoming possible: CMRO2 can be obtained using very advanced functional magnetic resonance imaging (fMRI) techniques with respiratory manipulations, while CMRGlu can be estimated by positron emission tomography (PET) using the tracer 18F-fluorodeoxyglucose (FDG-PET). A lower-than-normal ratio between CMRO2 and CMRGlu coupled with a decrease in CMRGlu in any brain area is taken to be indicative of locally impaired brain energetics, related to altered mitochondrial function.
The investigators hypothesize that (i) brain energetics, measured as the ratio CMRO2/CMRGlu is altered early in Parkinson's disease (PD) compared to age-matched healthy controls (HC) and continues to be altered as disease progresses; and (ii) exercise will positively affect alterations in brain energetics in PD subjects.
The investigators will recruit up to 30 PD subjects who are not habitual exercisers and up to 10 PD subjects who are habitual exercises. The 30 non-exercisers will undergo a supervised six month exercise intervention in groups, with PET/MRI scans before and after. The 10 exercisers will only be scanned once (for observational comparisons with the non-exercisers at baseline) and will not undergo the exercise intervention. In a separate study, the investigators will recruit up to 30 HCs to compare to compare their brain energetics metrics with those of the PD subjects at baseline to test hypothesis (i). Of the 30 non-exercisers, half will be assigned to start the exercise intervention immediately after their baseline scan, and the other half will have a six month delayed start to the intervention. During the delay, subjects will perform passive exercise in groups, to control for social interaction and possible placebo effects. Longitudinal comparisons of the non-exercisers before and after the intervention will test hypothesis (ii).
The objectives of this study are twofold: to (i) investigate a disease-initiating mechanism (abnormal mitochondrial function and impaired cellular bioenergetics), which could constitute a novel therapeutic target; and to (ii) study the effects of the intervention: while this will be a pilot study, involving limited exercise regimens, any knowledge gained about the impact of exercise on brain energetics will have a tremendous impact on the design of neuroprotective therapies and personalized treatment.
- Conditions
- Parkinson Disease
- Being tested
- Active exercise, Passive exercise
- Keywords
- Parkinson's disease, Exercise, Brain energetics, Positron Emission Tomography, MRI, PET
- 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.
Active exerciseOther
Thrice-weekly supervised intense aerobic exercise classes on cycle ergometers, in groups, for six months. Percentage of VO2 max will be used to regulate exercise intensity, based on an initial aerobic exercise test.
Passive exerciseOther
Thrice-weekly supervised passive exercise classes consisting of stretching and/or yoga, in groups, for six months.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention start: active exercise | Active comparator | Immediately starts the six month intervention of active exercise following the baseline scan. Receives: Other: Active exercise |
| Delayed intervention start: passive exercise | Placebo comparator | Starts the six month intervention of active exercise six months after the baseline scan. During the six month delay, participants in this arm undergo passive exercise. Receives: Other: Active exercise; Other: Passive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/MRI
CMRO2 will be computed from MRI data and CMRGlu from PET data; their ratio will be used to assess brain energetics.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start26 Jan 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Parkinson's Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
- Investigators
- Vesna Sossi, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426786
- Sponsor's protocol ID
- H19-01839
- Acronym
- EBEPD
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2020
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Brain Energetics in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04426786
- Acronym / sponsor ID
- EBEPD / H19-01839
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Exercise, Brain energetics, Positron Emission Tomography, MRI, PET
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pacific Parkinson's Research CentreUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Jun 2020 (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.
There is increasing evidence that the usage and delivery of energy to the brain, known as brain energetics, is altered in people with Parkinson's disease (PD). This project will explore whether exercise has a positive impact on brain energetics using functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) brain scanning in PD subjects.
PD subjects will be scanned before and after a supervised exercise program to investigate the effect of exercise on brain energetics. In a separate study, the investigators will also scan healthy volunteers to compare brain energetics in the healthy brain with the brain energetics data in PD subjects acquired in this study.
Detailed description
Previous work has investigated the link between decreased brain energetics (through mitochondrial dysfunction), though an investigation in-vivo has never been feasible due to technology constraints. Furthermore, recent work has suggested exercise may help reduce the effect of mitochondrial dysfunction. There is thus compelling evidence to investigate brain energetics/mitochondrial function in-vivo, in health, at different stages of disease and the relationship to exercise. While such measurements are intrinsically difficult, a useful measure is expected to be derived from the ratio between the cerebral metabolic rate of oxygen (CMRO2) and the cerebral metabolic rate of glucose (CMRGlu), if they are measured simultaneously. The simultaneous aspect of the two measurements is extremely important as diurnal variations in CMRO2 can be as high as 20%, while those in CMRGlu as high as 38%. Fortunately, given recent advances in measurement technique and instrumentation development, such studies are now becoming possible: CMRO2 can be obtained using very advanced functional magnetic resonance imaging (fMRI) techniques with respiratory manipulations, while CMRGlu can be estimated by positron emission tomography (PET) using the tracer 18F-fluorodeoxyglucose (FDG-PET). A lower-than-normal ratio between CMRO2 and CMRGlu coupled with a decrease in CMRGlu in any brain area is taken to be indicative of locally impaired brain energetics, related to altered mitochondrial function.
The investigators hypothesize that (i) brain energetics, measured as the ratio CMRO2/CMRGlu is altered early in Parkinson's disease (PD) compared to age-matched healthy controls (HC) and continues to be altered as disease progresses; and (ii) exercise will positively affect alterations in brain energetics in PD subjects.
The investigators will recruit up to 30 PD subjects who are not habitual exercisers and up to 10 PD subjects who are habitual exercises. The 30 non-exercisers will undergo a supervised six month exercise intervention in groups, with PET/MRI scans before and after. The 10 exercisers will only be scanned once (for observational comparisons with the non-exercisers at baseline) and will not undergo the exercise intervention. In a separate study, the investigators will recruit up to 30 HCs to compare to compare their brain energetics metrics with those of the PD subjects at baseline to test hypothesis (i). Of the 30 non-exercisers, half will be assigned to start the exercise intervention immediately after their baseline scan, and the other half will have a six month delayed start to the intervention. During the delay, subjects will perform passive exercise in groups, to control for social interaction and possible placebo effects. Longitudinal comparisons of the non-exercisers before and after the intervention will test hypothesis (ii).
The objectives of this study are twofold: to (i) investigate a disease-initiating mechanism (abnormal mitochondrial function and impaired cellular bioenergetics), which could constitute a novel therapeutic target; and to (ii) study the effects of the intervention: while this will be a pilot study, involving limited exercise regimens, any knowledge gained about the impact of exercise on brain energetics will have a tremendous impact on the design of neuroprotective therapies and personalized treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention start: active exercise | Active comparator | Other: Active exerciseImmediately starts the six month intervention of active exercise following the baseline scan. |
| Delayed intervention start: passive exercise | Placebo comparator | Other: Active exercise, Other: Passive exerciseStarts the six month intervention of active exercise six months after the baseline scan. During the six month delay, participants in this arm undergo passive exercise. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
- Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
- Currently exercise less than 120 minutes per week (PD non-exercisers)
- atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- significant osteoporosis or arthritis;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Active exerciseThrice-weekly supervised intense aerobic exercise classes on cycle ergometers, in groups, for six months. Percentage of VO2 max will be used to regulate exercise intensity, based on an initial aerobic exercise test. | Other | Delayed intervention start: passive exercise, Immediate intervention start: active exercise |
| Passive exerciseThrice-weekly supervised passive exercise classes consisting of stretching and/or yoga, in groups, for six months. | Other | Delayed intervention start: passive exercise |
Primary outcome
PET/MRI
Time frame: Six months
CMRO2 will be computed from MRI data and CMRGlu from PET data; their ratio will be used to assess brain energetics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- 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.
Vesna Sossi principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active exercise and Passive 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 42 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
PET/MRI (time frame: Six months). 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 2 Sep 2026.