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The ParkCycle Study: Aerobic Exercise in PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Exercise
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Neuroprotective, Intensive exercise

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    • 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

Sites / Locations

  • Cleveland clinic
  • UMC St Radboud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Twente patients will perform Aerobic exercise 3 times a week for at least 30 min

Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

UPDRS
Cognitive tests
MMSE and SCOPA-org
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
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.
maximal exercise test
to determine training load and subject fitness
feasibility parameters
Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate.
neuroplasticity
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. 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.

Full Information

First Posted
March 19, 2012
Last Updated
November 12, 2014
Sponsor
Radboud University Medical Center
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01562496
Brief Title
The ParkCycle Study: Aerobic Exercise in PD
Official Title
The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Neuroprotective, Intensive exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Twente patients will perform Aerobic exercise 3 times a week for at least 30 min
Arm Title
Control
Arm Type
No Intervention
Arm Description
Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Trails A and B task
Description
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.
Time Frame
every month for 6-7 months
Secondary Outcome Measure Information:
Title
UPDRS
Time Frame
baseline and after 6 months follow-up (FU)
Title
Cognitive tests
Description
MMSE and SCOPA-org
Time Frame
baseline and after 6 months FU
Title
Kinetics tests
Description
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
Time Frame
baseline and after 6 months FU
Title
questionaires
Description
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.
Time Frame
baseline and after 6 months FU
Title
maximal exercise test
Description
to determine training load and subject fitness
Time Frame
baseline and after 6 months FU
Title
feasibility parameters
Description
Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate.
Time Frame
after 6 months (termination of intervention)
Title
neuroplasticity
Description
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. 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.
Time Frame
baseline and after 6 months FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bas Bloem, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UMC St Radboud
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

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The ParkCycle Study: Aerobic Exercise in PD

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