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Trial record 1 of 1 for:    NCT01219231
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Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)

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ClinicalTrials.gov Identifier: NCT01219231
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE October 12, 2010
First Posted Date  ICMJE October 13, 2010
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE August 2010
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
Auditory Verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
  • Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ]
  • Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Official Title  ICMJE Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?
Brief Summary The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Impaired Glucose Tolerance
Intervention  ICMJE Behavioral: Exercise
6 months of aerobic exercise
Study Arms  ICMJE
  • Experimental: Exercise
    Intervention: Behavioral: Exercise
  • Placebo Comparator: Placebo
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 12, 2010)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01219231
Other Study ID Numbers  ICMJE exercise_neuromod
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Agnes Flöel, MD, Prof. Charité University Berlin
PRS Account Charite University, Berlin, Germany
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP