Parkinson Disease 10 Clinical Trial
— PETOfficial title:
The Effects of Exercise in Parkinson's Disease.
NCT number | NCT01835652 |
Other study ID # | H13-00276 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | March 2015 |
Verified date | March 2021 |
Source | Pacific Parkinson's Research Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Pacific Parkinson's Research Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Pacific Parkinson's Research Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Measures | 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. | 3 months | |
Primary | PET | Dopamine release will be assessed using positron emission tomography (PET) | 3 months | |
Secondary | fMRI | fMRI will be performed to record response to rewarding stimuli | 3 months |
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