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The Effect of Physical Activity on the Brain

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ClinicalTrials.gov Identifier: NCT01475396
Recruitment Status : Unknown
Verified June 2012 by University Hospital Muenster.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2011
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:
Physical activity is thought to increase overall body functions and to decrease cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80 years old healthy subjects take part in a prospective study with regular sports activity during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome measures, further investigations include MRT of the head, lactat- and other physical measures as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested to predict better cognitive performance.

Condition or disease Intervention/treatment Phase
Aerobic Exercise Anaerobic Exercise Unchanged Condition Behavioral: exercise Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly
Study Start Date : March 2006
Actual Primary Completion Date : March 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aerobic Exercise Behavioral: exercise
Experimental: Anaerobic Exercise Behavioral: exercise
No Intervention: Unchanged condition



Primary Outcome Measures :
  1. Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition [ Time Frame: 6 months ]
  2. Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition [ Time Frame: 6 months ]
  3. Change of performance in ms in a reaction time task after 6 months of intervention/control condition [ Time Frame: 6 months ]
  4. Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition [ Time Frame: 6 months ]
  2. Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition [ Time Frame: 6 months ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50-80 years old
  • healthy
  • lesser activity

Exclusion Criteria:

  • regular physical activity
  • diabetes
  • stroke
  • heavy smoking, drinking,
  • BMI < 20
  • MMSE < 25

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 ClinicalTrials.gov identifier (NCT number): NCT01475396


Locations
Germany
University Hospital of Muenster
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Agnes Flooel, MD University Hospital of Muenster
Study Director: Stefan Knecht, MD University Hospital of Muenster

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01475396     History of Changes
Other Study ID Numbers: Exercise_Neuromod
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by University Hospital Muenster:
exercise
physical activity
cognition
brain
aging
BDNF