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

The Effects of Exercise in Parkinson's Disease.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease 10
• Intervention / Treatment: Other: Active Exercise; Other: Passive Exercise

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Pacific Parkinson's Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET	Dopamine release will be assessed using positron emission tomography (PET)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI	fMRI will be performed to record response to rewarding stimuli	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Parkinson's Disease; Positron Emission Tomography; fMRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: H13-00276