Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Aerobic Exercise to Improve Executive Language Function In Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00979069
First received: September 15, 2009
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: September 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aging
Intervention: Behavioral: Aerobic group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aerobic Group

12 weeks of aerobic exercise 3 times a week

Aerobic group: 12 weeks of aerobic exercise 3 times a week

Control Group No contact control

Participant Flow:   Overall Study
    Aerobic Group     Control Group  
STARTED     10     10  
COMPLETED     10     8  
NOT COMPLETED     0     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Aerobic Group

12 weeks of aerobic exercise 3 times a week

Aerobic group: 12 weeks of aerobic exercise 3 times a week

Control Group No contact control
Total Total of all reporting groups

Baseline Measures
    Aerobic Group     Control Group     Total  
Number of Participants  
[units: participants]
  10     8     18  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     10     8     18  
Gender  
[units: participants]
     
Female     6     4     10  
Male     4     4     8  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     1     3  
White     6     4     10  
More than one race     0     1     1  
Unknown or Not Reported     2     2     4  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     8     6     14  
Unknown or Not Reported     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     10     8     18  



  Outcome Measures

1.  Primary:   Executive Language Functions   [ Time Frame: number of correct words at pre and post separated by 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Joe Nocera
Organization: Atlanta VAMC
phone: 404 321 6111 ext 6354
e-mail: joe.nocera2@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00979069     History of Changes
Other Study ID Numbers: E6860-M
Study First Received: September 15, 2009
Results First Received: September 18, 2014
Last Updated: November 13, 2014
Health Authority: United States: Federal Government