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Exercise and Inflammation in the Elderly (IRIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Maryland
Johns Hopkins University
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00753363
First received: September 12, 2008
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Inflammation
Insulin Sensitivity
Interventions: Other: Weight Loss
Other: Aerobic Exercise Training

  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
Arm 1

6 months of aerobic exercise training

Aerobic Exercise Training: 6 months of aerobic exercise training

Arm 2

6 months of weight loss

Weight Loss: 6 months of weight loss


Participant Flow:   Overall Study
    Arm 1   Arm 2
STARTED   59   60 
COMPLETED   19   21 
NOT COMPLETED   40   39 



  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
Arm 1

6 months of aerobic exercise training

Aerobic Exercise Training: 6 months of aerobic exercise training

Arm 2

6 months of weight loss

Weight Loss: 6 months of weight loss

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   60   119 
Age, Customized 
[Units: Years]
Mean (Full Range)
     
Age   62 
 (45 to 81) 
 61 
 (49 to 74) 
 61 
 (45 to 81) 
Gender 
[Units: Participants]
     
Female   40   40   80 
Male   19   20   39 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 32.4  (6.0)   35.7  (4.4)   34.1  (5.6) 


  Outcome Measures
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1.  Primary:   Insulin Sensitivity   [ Time Frame: Baseline and 6 month ]

2.  Secondary:   Body Weight   [ Time Frame: Baseline and 6 month ]

3.  Secondary:   Fitness   [ Time Frame: Baseline and 6 month ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alice Ryan
Organization: Baltimore VAMC
phone: 410-605-7851
e-mail: aryan@grecc.umaryland.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00753363     History of Changes
Other Study ID Numbers: AGCG-003-05F
Study First Received: September 12, 2008
Results First Received: October 15, 2014
Last Updated: July 7, 2016
Health Authority: United States: Federal Government