Exercise & Brain Energetics in PD (EBEPD)

November 4, 2024 updated by: Pacific Parkinson's Research Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Recruiting
        • Pacific Parkinson's Research Centre
        • Contact:
          • Jess McKenzie
          • Phone Number: 604-822-7764
        • Principal Investigator:
          • Vesna Sossi, PhD
        • Sub-Investigator:
          • A. Jon Stoessl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
  2. Mild to moderate Parkinsonism (Hoehn & Yahr stages I-III)
  3. Currently exercise less than 120 minutes per week (PD non-exercisers)

General exclusion criteria:

  1. atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
  2. significant osteoporosis or arthritis;
  3. history of cancer within 5 years of study participation;
  4. high dose of radiation from other procedures within the year;
  5. not able to tolerate being off PD medication for up to 24 hours;
  6. a female subject who is breast-feeding or pregnant;
  7. current or past substance use problems;
  8. serious head injury with loss of consciousness for ≥ 5 minutes;
  9. people with other chronic diseases such as diabetes, kidney problems, high blood pressure, other known neurological disorders, or heart diseases;
  10. 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.
  11. current or past neurological disorder (e.g. strokes, seizures, neurodegenerative disease other than Parkinson's disease);
  12. current or past psychiatric disorders (e.g. depression, anxiety disorders);
  13. severe claustrophobia (a fear of closed in spaces);
  14. weight of more than 158kg (347 lbs);
  15. inability to lay still for up to 90 minutes;
  16. are not medically cleared to exercise;
  17. 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:

  1. Machinist or metalworkers;
  2. cardiac pacemakers, wires, or defibrillator;
  3. past injury where a piece of metal lodged in your eye or orbit;
  4. ferromagnetic aneurysm clip;
  5. artificial heart valve;
  6. electrical stimulator for nerves or bones;
  7. ear or eye implant;
  8. implanted drug infusion pump;
  9. coil, catheter, or filter in any blood vessel;
  10. orthopedic hardware (artificial joint, plate, screws);
  11. other metallic prostheses;
  12. shrapnel, bullets, or other metal fragments;
  13. dentures, braces, or retainer;
  14. surgery (brain or otherwise), tattoos, or injection into a joint in the last 6 weeks;
  15. pierced body parts (other than earrings) or tattooed eyeliner;
  16. non-MRI safe intrauterine device (IUD).

Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:

  1. significant cognitive impairment or depression;
  2. significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening aerobic exercise test;
  3. failure to comply with the exercise intervention program by not completing at least 60 of the 72 exercise classes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Immediate intervention start: active exercise
Immediately starts the six month intervention of active exercise following the baseline scan.
Other: Active exercise
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.
Placebo Comparator: Delayed intervention start: passive exercise
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.
Other: Active exercise
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.
Other: Passive exercise
Thrice-weekly supervised passive exercise classes consisting of stretching and/or yoga, in groups, for six months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Six months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical measure: motor function
Time Frame: Six months
Motor function will be assessed using the MDS-Unified Parkinson's Disease Rating Scale (part III). The scale consists of 18 questions with each assigned a value in the range 0-4. Higher values indicate increasingly severe motor complications.
Six months
Clinical measure: cognitive function
Time Frame: Six months
Cognitive function will be assessed using the Montreal Cognitive Assessment. The assessment produces a score out of 30. Lower scores indicate increasingly impaired cognitive function.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacific Parkinson's Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Natural Sciences and Engineering Research Council, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vesna Sossi, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H19-01839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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