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The Effect of Physical Activity on the Brain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01475396
First received: November 7, 2011
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Aerobic Exercise
Anaerobic Exercise
Unchanged Condition
 Behavioral: exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change of performance in ms in a reaction time task after 6 months of intervention/control condition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2006
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Exercise Behavioral: exercise
Experimental: Anaerobic Exercise Behavioral: exercise
No Intervention: Unchanged condition

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01475396     History of Changes
Other Study ID Numbers: Exercise_Neuromod
Study First Received: November 7, 2011
Last Updated: June 18, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 23, 2013