PET: The Effects of Exercise in Parkinson's Disease

Sponsor
Pacific Parkinson's Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT01835652
Collaborator
(none)
18
1
2
23
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Active Exercise
  • Other: Passive Exercise
N/A

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).

Study Design

Study Type:
Interventional
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 :
Apr 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Exercise

Aerobic Exercise Intervention (stationary cycling)

Other: Active Exercise

Other: Passive Exercise

Passive Exercise (stretching and balance based exercise)

Other: Passive Exercise

Outcome Measures

Primary Outcome Measures

  1. PET [3 months]

    Dopamine release will be assessed using positron emission tomography (PET)

Secondary Outcome Measures

  1. fMRI [3 months]

    fMRI will be performed to record response to rewarding stimuli

Other Outcome Measures

  1. Clinical Measures [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pacific Parkinson's Research Centre Vancouver British Columbia Canada V6T 2B5

Sponsors and Collaborators

  • Pacific Parkinson's Research Centre

Investigators

  • Study Director: Jessamyn McKenzie, Pacific Parkinson's Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 19, 2013
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Keywords provided by A. Jon Stoessl, Director, Pacific Parkinson's Research Centre, Pacific Parkinson's Research Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2021