The Immune Function Intervention Trial (ImFIT)

Physical Activity, Aging and Immune Function

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

Study Overview

• Status: Completed
• Conditions: Immune Response
• Intervention / Treatment: Behavioral: cardiovascular exercise training; 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois at Urbana-Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 62 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens	baseline, 6 and 10 months

Secondary Outcome Measures

Outcome Measure
cardiovascular fitness
psychosocial outcomes

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jeffrey A. Woods, PhD, University of Illinois at Urbana-Champaign

Publications and helpful links

General Publications

• Woods JA, Lowder TW, Keylock KT. Can exercise training improve immune function in the aged? Ann N Y Acad Sci. 2002 Apr;959:117-27. doi: 10.1111/j.1749-6632.2002.tb02088.x.
• Woods JA, Ceddia MA, Wolters BW, Evans JK, Lu Q, McAuley E. Effects of 6 months of moderate aerobic exercise training on immune function in the elderly. Mech Ageing Dev. 1999 Jun 1;109(1):1-19. doi: 10.1016/s0047-6374(99)00014-7.
• Kohut ML, Cooper MM, Nickolaus MS, Russell DR, Cunnick JE. Exercise and psychosocial factors modulate immunity to influenza vaccine in elderly individuals. J Gerontol A Biol Sci Med Sci. 2002 Sep;57(9):M557-62. doi: 10.1093/gerona/57.9.m557.

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 24, 2007
• First Posted (Estimate): October 25, 2007

Study Record Updates

• Last Update Posted (Estimate): January 27, 2009
• Last Update Submitted That Met QC Criteria: January 23, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: AG0088; NIH R01 AG-18861