- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219231
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.
Referring to animal data, empirical studies, and pilot human trials, exercise should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with impaired glucose tolerance during a short term exercise program.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Berlin, Germany
- Department of Neurology, Charité Universitätsmedizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- subjects with impaired glucose tolerance
- 50-65 years old
- moderate to heavy weight (BMI 25-35)
- must be able to do exercise intervention
Exclusion Criteria:
- diabetes
- younger than 50 years
- BMI < 25
- psychiatric medication
- severe disease
- MMSE < 26
- severe cardiovascular disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
6 months of aerobic exercise
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Experimental: Exercise
|
6 months of aerobic exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Auditory Verbal Learning Task
Time Frame: Prior to intervention and after 6 months of intervention
|
Prior to intervention and after 6 months of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional/Structural brain changes
Time Frame: Prior to intervention and after 6 months of intervention
|
Prior to intervention and after 6 months of intervention
|
Plasma biomarkers
Time Frame: Prior to intervention and after 6 months of intervention
|
Prior to intervention and after 6 months of intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Agnes Flöel, MD, Prof., Charite University Berlin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Exercise_Neuromod
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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