Parkinson Disease 10PETNCT01835652
The Effects of Exercise in Parkinson's Disease
A study testing Active Exercise and Passive Exercise in people with Parkinson Disease 10, run by Pacific Parkinson's Research Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease 10
- What is being tested?
- Active Exercise and Passive Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
- Ages 40-70
- Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
Who cannot join
- General exclusion criteria will include:
- 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;
Show all 32Show fewer
- 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.
- Exclusion criteria for MRI scanning and magnetic stimulation from rTMS scanning includes:
- artificial heart valve;
- brain aneurysm clip;
- electrical stimulator for nerves or bones;
- ear or eye implant;
- implanted drug infusion pump;
- coil, catheter, or filter in any blood vessel;
- orthopedic hardware (artificial joint, plate, screws);
- other metallic prostheses;
- shrapnel, bullets, or other metal fragments;
- surgery or tattoos (including tattooed eyeliner) in the last six weeks;
- have a cardiac pacemaker, wires or defibrillator;
- have had an injury where a piece of metal lodged in your eye or orbit;
- have a ferromagnetic aneurysm clip; and
- have a history of seizures.
- Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:
- significant cognitive impairment (Montreal Cognitive Assessment score < 24) or depression (Beck Depression Inventory score > 18);
- significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
- failure to comply with the exercise or yoga/stretching intervention program, including missing 5 sessions or missing three sessions in a row.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6T 2B5
About this study
Official title: 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.
Read the 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).
- Conditions
- Parkinson Disease 10
- Being tested
- Active Exercise, Passive Exercise
- Keywords
- Exercise, Parkinson's Disease, Positron Emission Tomography, fMRI
- Medical subject headings
- Parkinson Disease 10, Motor Activity, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ExerciseOther
Passive ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Active Exercise | Active comparator | Aerobic Exercise Intervention (stationary cycling) Receives: Other: Active Exercise |
| Passive Exercise | Other | Passive Exercise (stretching and balance based exercise) Receives: Other: Passive Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET
Dopamine release will be assessed using positron emission tomography (PET)
Measured: 3 months
Secondary outcomes (1)
fMRI
fMRI will be performed to record response to rewarding stimuli
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease 10Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Parkinson's Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Jon Stoessl, Pacific Parkinson's Research Centre
- Investigators
- Jessamyn McKenzie, Study director, Pacific Parkinson's Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835652
- Sponsor's protocol ID
- H13-00276
- Acronym
- PET
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2013
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38588457Ernst 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.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT01835652
- Acronym / sponsor ID
- PET / H13-00276
- Conditions
- Parkinson Disease 10
- Keywords
- Exercise, Parkinson's Disease, Positron Emission Tomography, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pacific Parkinson's Research CentreUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Exercise | Active comparator | Other: Active ExerciseAerobic Exercise Intervention (stationary cycling) |
| Passive Exercise | Other | Other: Passive ExercisePassive Exercise (stretching and balance based exercise) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic PD according to UK Brain Bank criteria (modified to permit inclusion of subjects with a family history)
- Ages 40-70
- Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
Key exclusion criteria (32 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Exercise | Other | Active Exercise |
| Passive Exercise | Other | Passive Exercise |
Primary outcome
PET
Time frame: 3 months
Dopamine release will be assessed using positron emission tomography (PET)
1 secondary outcome
fMRI
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36602886Ernst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessamyn McKenzie study director
Pacific Parkinson's Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Exercise and Passive Exercise in people with Parkinson Disease 10, run by Pacific Parkinson's Research Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01835652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.