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Effects of Physical Activity on the Brain in Parkinson's Disease (PD)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
stationary bike exercise
aerobic
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson's Disease

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • UPDRS <15
  • L-DOPA responsive
  • <5 yrs since diagnosis

Exclusion Criteria:

  • severe other diseases
  • MMSE < 26
  • treatment with psychiatric medication

Sites / Locations

  • Department of Neurology, Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

stationary bike exercise

aerobic

Arm Description

6 months of exercise (60% of anaerobic threshold)

6 months of exercise <30% anaerobic threshold

Outcomes

Primary Outcome Measures

UPDRS motor score

Secondary Outcome Measures

Functional/Structural brain changes
Plasma biomarkers
Cognitive Function based on neuropsychological test-performance

Full Information

First Posted
December 3, 2012
Last Updated
March 15, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01741584
Brief Title
Effects of Physical Activity on the Brain in Parkinson's Disease (PD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate whether exercise improves cognitive and motor functions in Parkinson's disease. To test this hypothesis, the researchers study general brain functions in subjects with PD during a 6-months exercise program.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stationary bike exercise
Arm Type
Experimental
Arm Description
6 months of exercise (60% of anaerobic threshold)
Arm Title
aerobic
Arm Type
Placebo Comparator
Arm Description
6 months of exercise <30% anaerobic threshold
Intervention Type
Behavioral
Intervention Name(s)
stationary bike exercise
Intervention Type
Behavioral
Intervention Name(s)
aerobic
Primary Outcome Measure Information:
Title
UPDRS motor score
Time Frame
Prior to intervention and after 6 months of intervention
Secondary Outcome Measure Information:
Title
Functional/Structural brain changes
Time Frame
Prior to intervention and after 6 months of intervention
Title
Plasma biomarkers
Time Frame
Prior to intervention and after 6 months of intervention
Title
Cognitive Function based on neuropsychological test-performance
Time Frame
Prior to intervention and after 6 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: UPDRS <15 L-DOPA responsive <5 yrs since diagnosis Exclusion Criteria: severe other diseases MMSE < 26 treatment with psychiatric medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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Effects of Physical Activity on the Brain in Parkinson's Disease (PD)

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