The Effect of Physical Activity on the Brain

Aerobic Exercise Clinical Trial

Official title:

Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01475396
• Other study ID #: Exercise_Neuromod
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 7, 2011
• Last updated: June 18, 2012
• Start date: March 2006
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 50-80 years old

• healthy

• lesser activity

Exclusion Criteria:

• regular physical activity

• diabetes

• stroke

• heavy smoking, drinking,

• BMI < 20

• MMSE < 25

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aerobic Exercise
• Anaerobic Exercise
• Unchanged Condition

Intervention

Behavioral:
• exercise

Locations

Country	Name	City	State
Germany	University Hospital of Muenster	Muenster	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition		6 months	No
Primary	Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition		6 months	No
Primary	Change of performance in ms in a reaction time task after 6 months of intervention/control condition		6 months	No
Primary	Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition		6 months	No
Secondary	Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition		6 months	No
Secondary	Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition		6 months	No