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The Effects of Exercise in Parkinson's Disease (PET)

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ClinicalTrials.gov Identifier: NCT01835652
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
A. Jon Stoessl, Pacific Parkinson's Research Centre

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease 10 Other: Active Exercise Other: Passive Exercise Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Exercise in Parkinson's Disease.
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Exercise
Aerobic Exercise Intervention (stationary cycling)
Other: Active Exercise
Passive Exercise
Passive Exercise (stretching and balance based exercise)
Other: Passive Exercise



Primary Outcome Measures :
  1. PET [ Time Frame: 3 months ]
    Dopamine release will be assessed using positron emission tomography (PET)


Secondary Outcome Measures :
  1. fMRI [ Time Frame: 3 months ]
    fMRI will be performed to record response to rewarding stimuli


Other Outcome Measures:
  1. Clinical Measures [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
  2. Ages 40-70
  3. Mild to moderate Parkinsonism (Hoehn & Yahr stages I-III)

Exclusion Criteria:

General exclusion criteria will include:

  1. more than 120 minutes per week of activities >3 MET or a score exceeding 4 on the "Baseline Exercise Screening Tool" (Appendix, Fig. 1);
  2. atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
  3. significant osteoporosis or arthritis;
  4. other neurological disease (e.g. myopathy);
  5. self-reports claustrophobia;
  6. history of cancer within 5 years of study participation;
  7. high dose of radiation from other procedures within the year;
  8. taking rasagiline or selegiline for PD therapy;
  9. diabetic;
  10. not able to tolerate being off PD medication for up to 24 hours;
  11. BMI of 35 or more; and
  12. a female subject who is breast-feeding or pregnant.

Exclusion criteria for MRI scanning and magnetic stimulation from rTMS scanning includes:

  1. artificial heart valve;
  2. brain aneurysm clip;
  3. electrical stimulator for nerves or bones;
  4. ear or eye implant;
  5. implanted drug infusion pump;
  6. coil, catheter, or filter in any blood vessel;
  7. orthopedic hardware (artificial joint, plate, screws);
  8. other metallic prostheses;
  9. shrapnel, bullets, or other metal fragments;
  10. surgery or tattoos (including tattooed eyeliner) in the last six weeks;
  11. have a cardiac pacemaker, wires or defibrillator;
  12. have had an injury where a piece of metal lodged in your eye or orbit;
  13. have a ferromagnetic aneurysm clip; and
  14. have a history of seizures.

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

  1. significant cognitive impairment (Montreal Cognitive Assessment score < 24) or depression (Beck Depression Inventory score > 18);
  2. significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
  3. failure to comply with the exercise or yoga/stretching intervention program, including missing 5 sessions or missing three sessions in a row.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835652


Locations
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Canada, British Columbia
Pacific Parkinson's Research Centre
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
Pacific Parkinson's Research Centre
Investigators
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Study Director: Jessamyn McKenzie Pacific Parkinson's Research Centre
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Responsible Party: A. Jon Stoessl, Director, Pacific Parkinson's Research Centre, Pacific Parkinson's Research Centre
ClinicalTrials.gov Identifier: NCT01835652    
Other Study ID Numbers: H13-00276
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by A. Jon Stoessl, Pacific Parkinson's Research Centre:
Exercise
Parkinson's Disease
Positron Emission Tomography
fMRI
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases