NCT01835652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

April 16, 2013

Last Update Submit

March 15, 2021

Conditions

Parkinson Disease 10

Keywords

ExerciseParkinson's DiseasePositron Emission TomographyfMRI

Outcome Measures

Primary Outcomes (1)

  • PET

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

    3 months

Secondary Outcomes (1)

  • fMRI

    3 months

Other Outcomes (1)

  • Clinical Measures

    3 months

Study Arms (2)

Active Exercise

ACTIVE COMPARATOR

Aerobic Exercise Intervention (stationary cycling)

Other: Active Exercise

Passive Exercise

OTHER

Passive Exercise (stretching and balance based exercise)

Other: Passive Exercise

Interventions

Active ExerciseOTHER
Active Exercise
Passive ExerciseOTHER
Passive Exercise

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 40-70
  • Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)

You may not qualify if:

  • 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.
  • artificial heart valve;
  • brain aneurysm clip;
  • electrical stimulator for nerves or bones;
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

Location

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease 10Motor ActivityParkinson Disease

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

BehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jessamyn McKenzie

    Pacific Parkinson's Research Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pacific Parkinson's Research Centre

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

CA(1)