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

March 15, 2016 updated by: Agnes Flöel, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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

  • Germany
      • Berlin, Germany, 10117
        • Department of Neurology, Charité Universitätsmedizin Berlin

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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stationary bike exercise
6 months of exercise (60% of anaerobic threshold)
Behavioral: stationary bike exercise
Placebo Comparator: aerobic
6 months of exercise <30% anaerobic threshold
Behavioral: aerobic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UPDRS motor score
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional/Structural brain changes
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention
Plasma biomarkers
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention
Cognitive Function based on neuropsychological test-performance
Time Frame: Prior to intervention and after 6 months of intervention
Prior to intervention and after 6 months of intervention

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Agnes Flöel, MD, Charite University, Berlin, Germany

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

December 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA_memory_01

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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