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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01741584
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: stationary bike exercise Behavioral: aerobic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : December 2010
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. UPDRS motor score [ Time Frame: Prior to intervention and after 6 months of intervention ]

Secondary Outcome Measures :
  1. Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ]
  2. Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ]
  3. Cognitive Function based on neuropsychological test-performance [ Time Frame: Prior to intervention and after 6 months of intervention ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01741584

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Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Agnes Flöel, MD Charite University, Berlin, Germany
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Responsible Party: Agnes Flöel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, Germany Identifier: NCT01741584    
Other Study ID Numbers: PA_memory_01
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases