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

This study has been completed.
Sponsor:
Collaborators:
Hvidovre University Hospital
Bispebjerg Hospital
Danish Parkinson Association
Information provided by (Responsible Party):
Martin Hoyer Rose, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01446549
First received: September 29, 2011
Last updated: September 22, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Parkinson's Disease
Other: High intensive antigravity locomotor exercise
Procedure: Deep Brain Stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Change in Isometric Tremor Approximate Entropy [ Time Frame: Change from baseline up to 16 weeks ] [ Designated as safety issue: No ]
    Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained.


Enrollment: 40
Study Start Date: July 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446549

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
University of Copenhagen
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
  More Information

No publications provided

Responsible Party: Martin Hoyer Rose, Principal Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01446549     History of Changes
Other Study ID Numbers: H-3-2010-051
Study First Received: September 29, 2011
Last Updated: September 22, 2013
Health Authority: Denmark: The Danish Data Protection Agency

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 31, 2014