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The Immune Function Intervention Trial (ImFIT)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00548990
First received: October 24, 2007
Last updated: January 23, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention
Immune Response
 Behavioral: cardiovascular exercise training
Behavioral: flexibility/balance control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Physical Activity, Aging and Immune Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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:
  • cardiovascular fitness
  • psychosocial outcomes

Enrollment: 150
Study Start Date: August 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   62 Years to 82 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00548990     History of Changes
Other Study ID Numbers: AG0088, NIH R01 AG-18861
Study First Received: October 24, 2007
Last Updated: January 23, 2009
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 23, 2013