Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High intensive antigravity locomotor exercise
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria (exercise arm):
- Idiopathic Parkinson's disease
- A stable condition the last 6 months
- Hoehn and Yahr 2 - 3
Inclusion Criteria (Deep Brain Stimulation arm):
- Patients referred to Deep Brain Stimulation
Exclusion Criteria:
- Cardiovascular disease
- Conditions that contraindicate physical exercise or the examination
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Deep Brain Stimulation
Locomotor Exercise
Arm Description
Outcomes
Primary Outcome Measures
Change in Isometric Tremor Approximate Entropy
Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained.
Secondary Outcome Measures
Full Information
NCT ID
NCT01446549
First Posted
September 29, 2011
Last Updated
September 22, 2013
Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital, Bispebjerg Hospital, Danish Parkinson Association
1. Study Identification
Unique Protocol Identification Number
NCT01446549
Brief Title
Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation
Official Title
Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital, Bispebjerg Hospital, Danish Parkinson Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is (1) to provide quantitative information of the motor manifestations of Parkinson's disease and (2) to quantify the effect of high intensive antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Title
Locomotor Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High intensive antigravity locomotor exercise
Intervention Description
High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation implantation
Primary Outcome Measure Information:
Title
Change in Isometric Tremor Approximate Entropy
Description
Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained.
Time Frame
Change from baseline up to 16 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (exercise arm):
Idiopathic Parkinson's disease
A stable condition the last 6 months
Hoehn and Yahr 2 - 3
Inclusion Criteria (Deep Brain Stimulation arm):
Patients referred to Deep Brain Stimulation
Exclusion Criteria:
Cardiovascular disease
Conditions that contraindicate physical exercise or the examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin H Rose, MSci
Organizational Affiliation
Department of Exercise and Sport Sciences, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bente R Jensen, MSci, PhD
Organizational Affiliation
Department of Exercise and Sport Sciences, University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stig Sonne-Holm, MD, DSc
Organizational Affiliation
Department of Orthopedic Surgery, Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annemette Løkkegaard, MD, PhD
Organizational Affiliation
Department of Neurology, Bispebjerg University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation
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