Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation

September 22, 2013 updated by: Martin Hoyer Rose, University of Copenhagen

Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep Brain Stimulation
Procedure: Deep Brain Stimulation
Deep Brain Stimulation implantation
Experimental: Locomotor Exercise
Other: High intensive antigravity locomotor exercise
High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Isometric Tremor Approximate Entropy
Time Frame: Change from baseline up to 16 weeks
Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained.
Change from baseline up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital
Bispebjerg Hospital
Danish Parkinson Association

Investigators

  • Principal Investigator: Martin H Rose, MSci, Department of Exercise and Sport Sciences, University of Copenhagen
  • Study Chair: Bente R Jensen, MSci, PhD, Department of Exercise and Sport Sciences, University of Copenhagen
  • Study Chair: Stig Sonne-Holm, MD, DSc, Department of Orthopedic Surgery, Hvidovre University Hospital
  • Study Chair: Annemette Løkkegaard, MD, PhD, Department of Neurology, Bispebjerg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 22, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2010-051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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