The Immune Function Intervention Trial (ImFIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00548990|
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : January 27, 2009
|Condition or disease||Intervention/treatment||Phase|
|Immune Response||Behavioral: cardiovascular exercise training Behavioral: flexibility/balance control||Not Applicable|
The extent to which exercise training or long-term physical activity influences poorly regulated immune function in the elderly is unclear. Preliminary evidence suggests that exercise training may improve various immune function measures in older adults. Although such findings have the potential to be of substantial public health importance, the majority of studies have suffered from small sample sizes, inadequate measurement of physical fitness, and weak research designs.
This study is designed to overcome these limitations by employing a longitudinal randomized controlled trial examining the effect of exercise training on clinically relevant immune function measures in older adults (65-80 years). Moreover, relationships between several factors known to be altered by exercise training and changes in immune function will be assessed. As such, there are two specific aims to be addressed. In Aim 1, a 10-month exercise trial will determine whether moderate intensity aerobic exercise training can improve immune function in previously sedentary older adults. In Aim 2, the role played by physiological, behavioral, and psychosocial factors in the relationship between exercise training and improved immune function will be examined.
150 sedentary participants will be randomly assigned to either a 10-month moderate aerobic exercise training program or a sedentary control group. Clinically relevant measures of immune function including the delayed-type hypersensitivity (DTH) response to a battery of antigens and the antibody response to tetanus toxoid and influenza virus vaccination will be assessed before, during and after the intervention. We hypothesize that exercise training will result in improved immune responses including higher peak antibody titers and DTH responses, and sustained levels of protective antibodies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Physical Activity, Aging and Immune Function|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
a 10-month moderate aerobic exercise training program
|Behavioral: cardiovascular exercise training|
Placebo Comparator: 2
flexibility/balance control group
|Behavioral: flexibility/balance control|
- antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens [ Time Frame: baseline, 6 and 10 months ]
- cardiovascular fitness
- psychosocial outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548990
|United States, Illinois|
|University of Illinois at Urbana-Champaign|
|Urbana, Illinois, United States, 61801|
|Principal Investigator:||Jeffrey A. Woods, PhD||University of Illinois at Urbana-Champaign|