The Effect of Physical Activity on the Brain

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01475396
• Collaborator: German Federal Ministry of Education and Research (Other)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 81.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2006
• Actual Primary Completion Date: Mar 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition [6 months]

2. Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition [6 months]

3. Change of performance in ms in a reaction time task after 6 months of intervention/control condition [6 months]

4. Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition [6 months]

Secondary Outcome Measures

1. Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition [6 months]

2. Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Muenster
• ClinicalTrials.gov Identifier: NCT01475396
• Other Study ID Numbers: Exercise_Neuromod
• First Posted: Nov 21, 2011
• Last Update Posted: Jun 19, 2012
• Last Verified: Jun 1, 2012

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

Study Results

No Results Posted as of Jun 19, 2012