Back to resultsThe Effects of Exercise in Parkinson's Disease (PET)
Primary Purpose
Parkinson Disease 10
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active Exercise
Passive Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease 10 focused on measuring Exercise, Parkinson's Disease, Positron Emission Tomography, fMRI
Eligibility Criteria
Inclusion Criteria:
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
- Ages 40-70
- Mild to moderate Parkinsonism (Hoehn & Yahr stages I-III)
Exclusion Criteria:
General exclusion criteria will include:
- more than 120 minutes per week of activities >3 MET or a score exceeding 4 on the "Baseline Exercise Screening Tool" (Appendix, Fig. 1);
- atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- significant osteoporosis or arthritis;
- other neurological disease (e.g. myopathy);
- self-reports claustrophobia;
- history of cancer within 5 years of study participation;
- high dose of radiation from other procedures within the year;
- taking rasagiline or selegiline for PD therapy;
- diabetic;
- not able to tolerate being off PD medication for up to 24 hours;
- BMI of 35 or more; and
- a female subject who is breast-feeding or pregnant.
Exclusion criteria for MRI scanning and magnetic stimulation from rTMS scanning includes:
- artificial heart valve;
- brain aneurysm clip;
- 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;
- surgery or tattoos (including tattooed eyeliner) in the last six weeks;
- have a cardiac pacemaker, wires or defibrillator;
- have had an injury where a piece of metal lodged in your eye or orbit;
- have a ferromagnetic aneurysm clip; and
- have a history of seizures.
Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:
- significant cognitive impairment (Montreal Cognitive Assessment score < 24) or depression (Beck Depression Inventory score > 18);
- significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
- failure to comply with the exercise or yoga/stretching intervention program, including missing 5 sessions or missing three sessions in a row.
Sites / Locations
- Pacific Parkinson's Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Active Exercise
Passive Exercise
Arm Description
Aerobic Exercise Intervention (stationary cycling)
Passive Exercise (stretching and balance based exercise)
Outcomes
Primary Outcome Measures
PET
Dopamine release will be assessed using positron emission tomography (PET)
Secondary Outcome Measures
fMRI
fMRI will be performed to record response to rewarding stimuli
Full Information
NCT ID
NCT01835652
First Posted
April 16, 2013
Last Updated
March 15, 2021
Sponsor
Pacific Parkinson's Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT01835652
Brief Title
The Effects of Exercise in Parkinson's Disease
Acronym
PET
Official Title
The Effects of Exercise in Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Parkinson's Research Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Parkinson's disease is caused by a reduction of dopamine causing motor deficits. The investigators are studying how exercise can help PD patients by increasing dopamine release in an area of the brain that coordinates movement, the striatum. The investigators will enroll PD patients into two groups; one group will complete a 12-week aerobic exercise program and the other will complete a 12-week control program including yoga and stretching only. The investigators will measure changes in dopamine release before and after either 12-week intervention. Subjects will complete motor and cognitive questionnaires in addition to functional magnetic resonance imaging and positron emission tomography neuroimaging.
Detailed Description
The purpose of this study is to determine the basis for symptomatic and disease modifying benefits of exercise in Parkinson's disease (PD).
Although the benefits of exercise in PD have been purported for several decades, only recently have there been controlled reports of symptomatic benefits in Parkinson's disease in terms of bradykinesia, postural balance and quality of life. There have been unsubstantiated suggestions that exercise may improve cognition and mood in PD.
The mechanisms underlying such benefits are poorly understood. Exercise may induce dopamine release, thereby contributing to improved motor function in the dorsal striatum, and to enhanced mood and reduced apathy in the ventral striatum.
We will test the hypotheses that exercise results in altered synaptic plasticity in the form of altered connectivity in response to aerobic exercise and reward-induced dopamine release. We will assess networks of functional connectivity using functional magnetic resonance imaging and measure dopamine release with positron emission tomography (PET).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease 10
Keywords
Exercise, Parkinson's Disease, Positron Emission Tomography, fMRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Exercise
Arm Type
Active Comparator
Arm Description
Aerobic Exercise Intervention (stationary cycling)
Arm Title
Passive Exercise
Arm Type
Other
Arm Description
Passive Exercise (stretching and balance based exercise)
Intervention Type
Other
Intervention Name(s)
Active Exercise
Intervention Type
Other
Intervention Name(s)
Passive Exercise
Primary Outcome Measure Information:
Title
PET
Description
Dopamine release will be assessed using positron emission tomography (PET)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
fMRI
Description
fMRI will be performed to record response to rewarding stimuli
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Clinical Measures
Description
Motor function will be assessed using the MDS-Unified Parkinson's Disease Rating Scale, finger tapping and Purdue Pegboard. Cognitive function will be assessed using the Montreal Cognitive Assessment, Wisconsin Card-Sorting Task, Trail-Making B Test and a computerized reaction time test. Mood and apathy will be assessed using the Beck Depression Inventory and Starkstein Apathy Scale.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
Ages 40-70
Mild to moderate Parkinsonism (Hoehn & Yahr stages I-III)
Exclusion Criteria:
General exclusion criteria will include:
more than 120 minutes per week of activities >3 MET or a score exceeding 4 on the "Baseline Exercise Screening Tool" (Appendix, Fig. 1);
atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
significant osteoporosis or arthritis;
other neurological disease (e.g. myopathy);
self-reports claustrophobia;
history of cancer within 5 years of study participation;
high dose of radiation from other procedures within the year;
taking rasagiline or selegiline for PD therapy;
diabetic;
not able to tolerate being off PD medication for up to 24 hours;
BMI of 35 or more; and
a female subject who is breast-feeding or pregnant.
Exclusion criteria for MRI scanning and magnetic stimulation from rTMS scanning includes:
artificial heart valve;
brain aneurysm clip;
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;
surgery or tattoos (including tattooed eyeliner) in the last six weeks;
have a cardiac pacemaker, wires or defibrillator;
have had an injury where a piece of metal lodged in your eye or orbit;
have a ferromagnetic aneurysm clip; and
have a history of seizures.
Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:
significant cognitive impairment (Montreal Cognitive Assessment score < 24) or depression (Beck Depression Inventory score > 18);
significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
failure to comply with the exercise or yoga/stretching intervention program, including missing 5 sessions or missing three sessions in a row.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessamyn McKenzie
Organizational Affiliation
Pacific Parkinson's Research Centre
Official's Role
Study Director
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
Learn more about this trial
The Effects of Exercise in Parkinson's Disease
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