- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475396
The Effect of Physical Activity on the Brain
June 18, 2012 updated by: University Hospital Muenster
Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
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
-
-
NRW
-
Muenster, NRW, Germany, 48149
- University Hospital of Muenster
-
-
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
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 50-80 years old
- healthy
- lesser activity
Exclusion Criteria:
- regular physical activity
- diabetes
- stroke
- heavy smoking, drinking,
- BMI < 20
- MMSE < 25
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: Aerobic Exercise
|
|
|
Experimental: Anaerobic Exercise
|
|
|
No Intervention: Unchanged condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition
Time Frame: 6 months
|
6 months
|
|
Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition
Time Frame: 6 months
|
6 months
|
|
Change of performance in ms in a reaction time task after 6 months of intervention/control condition
Time Frame: 6 months
|
6 months
|
|
Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition
Time Frame: 6 months
|
6 months
|
|
Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Agnes Flooel, MD, University Hospital of Muenster
- Study Director: Stefan Knecht, MD, University Hospital of Muenster
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
March 1, 2006
Primary Completion (Actual)
March 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
November 7, 2011
First Submitted That Met QC Criteria
November 16, 2011
First Posted (Estimate)
November 21, 2011
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
June 18, 2012
Last Verified
June 1, 2012
More Information
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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