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

NCT ID: NCT01446549

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type PROCEDURE

Deep Brain Stimulation implantation

Locomotor Exercise

Group Type EXPERIMENTAL

High intensive antigravity locomotor exercise

Intervention Type OTHER

High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.

Interventions

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High intensive antigravity locomotor exercise

High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.

Intervention Type OTHER

Deep Brain Stimulation

Deep Brain Stimulation implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's disease
* A stable condition the last 6 months
* Hoehn and Yahr 2 - 3


* Patients referred to Deep Brain Stimulation

Exclusion Criteria

* Cardiovascular disease
* Conditions that contraindicate physical exercise or the examination
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Danish Parkinson Association

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Martin Hoyer Rose

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin H Rose, MSci

Role: PRINCIPAL_INVESTIGATOR

Department of Exercise and Sport Sciences, University of Copenhagen

Bente R Jensen, MSci, PhD

Role: STUDY_CHAIR

Department of Exercise and Sport Sciences, University of Copenhagen

Stig Sonne-Holm, MD, DSc

Role: STUDY_CHAIR

Department of Orthopedic Surgery, Hvidovre University Hospital

Annemette Løkkegaard, MD, PhD

Role: STUDY_CHAIR

Department of Neurology, Bispebjerg University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-3-2010-051

Identifier Type: -

Identifier Source: org_study_id