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Parkinson's DiseaseNCT01562496

The ParkCycle Study: Aerobic Exercise in PD

A study testing Exercise in people with Parkinson's Disease, run by Radboud University Medical Center at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesin 2 countries
Study dates
Jan 2012to Oct 2014
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of idiopathic Parkinson's disease according to the UK Queen Square Brain Bank Criteria
  • Hoehn \& Yahr disease stages I-II
  • Age between 30 and 75 years
  • Having insufficient physical activity according to the ACSM guideline for adults, 50-64 years old with a chronic condition
  • Untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations.

Who cannot join

  • Unclear diagnosis with Red Flags
  • Advanced problems in cognitive functioning: Mini Mental State Examination (MMSE)19 score < 24
  • Serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner
  • Pulmonary diseases; known by specialist or medical practitioner
  • Stroke
  • High risk of cardiovascular complications:
Show all 20Show fewer
  • Hypertension (systole >150 and diastole > 100)
  • Diabetes Mellitus; known by specialist or medical practitioner
  • Cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner
  • Cardiac rhythm disorder; known by specialist or medical practitioner
  • Heart failure; known by specialist or medical practitioner
  • Use of ß-blockers
  • Not able to complete American (for Cleveland site) or Dutch questionnaires (for the Nijmegen site)
  • Daily institutionalized care
  • Contra-indications for fMRI:
  • Pregnancy
  • Metallic implants or electronic devices
  • Previous seizure
  • Claustrophobia
  • Not able to keep the head still for longer period, i.e. due to severe head tremor

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Cleveland clinic

    Cleveland, Ohio, 44195

Other trials in United States

Netherlands1 site

  • UMC St Radboud

    Nijmegen, 6500HB

Other trials in Netherlands

About this study

Official title: The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease

The primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.

Read the detailed description

Neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical need in Parkinson's disease (PD). Animal studies have shown that 'intensive' exercise improves motor function and may have neuroprotective properties. The promising animal results have not been translated to patients with PD so far. This is a two-cluster randomised control trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention on a stationary virtual reality bike and twenty patients (10 at each site)will serve as controls.

Being tested
Exercise
Keywords
Parkinson's disease, Neuroprotective, Intensive exercise
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    six-months long exercise intervention on a stationary virtual reality bike, 3-5 times a week, each session lasting 30-45 minutes at a target heart rate (60-85% heart rate reserve).

Study groups in NCT01562496
Study groupRoleWhat they receive
ExerciseExperimentalTwente patients will perform Aerobic exercise 3 times a week for at least 30 min
Receives: Behavioral: Exercise
ControlNo interventionFifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trails A and B task

    this test requires subjects to connect numbers on a screen from 1 to 25 (part A) and to connect numbers to letters. This neuropsychological test has already been proven to be sensitive to frontal lobe damage (e.g. Boll 1981) and has been recognised as an outcome for executive function in PD21. This test is performed using an online system called i-COMET that allows subject to complete the task weekly at home. Subjects have to login at the i-COMET website (https://i-comet.com) with a username and password that is provided to them by the research team.

    Measured: every month for 6-7 months

Secondary outcomes (7)

  1. UPDRS

    Measured: baseline and after 6 months follow-up (FU)

  2. Cognitive tests

    MMSE and SCOPA-org

    Measured: baseline and after 6 months FU

  3. Kinetics tests

    Timed Up and Go Test (iTUG) and a postural sway test, , as an objective measure for balance and mobility Finger tap test as a measure for bradykinesia and a pegboard test as a measure for complex motor function

    Measured: baseline and after 6 months FU

  4. questionaires

    The PDQ-39 is a PD specific questionnaire including 39 items concerning quality of life. Other non-motor features such as mood and sleep are respectively measured using the HADS and SCOPA-Sleep.

    Measured: baseline and after 6 months FU

  5. maximal exercise test

    to determine training load and subject fitness

    Measured: baseline and after 6 months FU

  6. feasibility parameters

    Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate.

    Measured: after 6 months (termination of intervention)

  7. neuroplasticity

    1. Volumetric brain changes: cerebral grey and white matter will be analyzed using Vox-Based Morphometry, a validated and fully automated technique for computational analysis of differences in global and local grey and/or white matter volume.
    2. Resting state brain perfusion: functional coupling between strial subregions and the cerebral cortex will be analyzed using multiple regression analyses on resting state functional MRI data.

    Measured: baseline and after 6 months FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01562496
Sponsor's protocol ID
NL38116.091.11
Status last verified
Nov 2014
First submitted
19 Mar 2012
Last updated
13 Nov 2014
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 38588457

  • 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.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Parkinson's Disease, run by Radboud University Medical Center at 2 sites in 2 countries.

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 5 inclusion and 20 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Netherlands. 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?

Trails A and B task (time frame: every month for 6-7 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 NCT01562496, 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 13 Nov 2014.

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