Overview

This trial is active, not recruiting.

Conditions aerobic exercise, anaerobic exercise, unchanged condition
Treatment exercise
Phase phase 3
Sponsor University Hospital Muenster
Collaborator German Federal Ministry of Education and Research
Start date March 2006
End date March 2012
Trial size 120 participants
Trial identifier NCT01475396, Exercise_Neuromod

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
exercise
(Experimental)
exercise
(No Intervention)

Primary Outcomes

Measure
Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition
time frame: 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
Change of performance in ms in a reaction time task after 6 months of intervention/control condition
time frame: 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

Secondary Outcomes

Measure
Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition
time frame: 6 months
Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition
time frame: 6 months

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

Inclusion Criteria: - 50-80 years old - healthy - lesser activity Exclusion Criteria: - regular physical activity - diabetes - stroke - heavy smoking, drinking, - BMI < 20 - MMSE < 25

Additional Information

Official title Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly
Principal investigator Agnes Flooel, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by University Hospital Muenster.