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The Immune Function Intervention Trial (ImFIT)

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ClinicalTrials.gov Identifier: NCT00548990
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : January 27, 2009
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
The purpose of the study is to examine whether cardiovascular exercise training improves immune responses to vaccination in previously sedentary older adults.

Condition or disease Intervention/treatment Phase
Immune Response Behavioral: cardiovascular exercise training Behavioral: flexibility/balance control Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
a 10-month moderate aerobic exercise training program
Behavioral: cardiovascular exercise training
Placebo Comparator: 2
flexibility/balance control group
Behavioral: flexibility/balance control



Primary Outcome Measures :
  1. antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens [ Time Frame: baseline, 6 and 10 months ]

Secondary Outcome Measures :
  1. cardiovascular fitness
  2. psychosocial outcomes


Information from the National Library of Medicine

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Ages Eligible for Study:   62 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 62-82
  • Ability to participate in an exercise program
  • Medical clearance by primary physician
  • Non-smoker
  • BMI 22-38
  • Independently living
  • Post-menopausal
  • Sedentary for over 6 months

Exclusion Criteria:

  • No recent history (within 6 months) of infection or vaccination
  • History of systemic reactions to vaccination
  • History of cancer
  • Severe allergies/asthma requiring prescription medication
  • Splenectomy or transplant patient
  • Chronic Obstructive Pulmonary Disease (COPD)
  • HIV positive
  • Uncontrolled diabetes or hypertension
  • Severe arthritis
  • Mental illness or clinical depression
  • Impaired cognitive status

Information from the National Library of Medicine

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


Locations
United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Jeffrey A. Woods, PhD University of Illinois at Urbana-Champaign