CClinicalTrials.gg
CompletedNCT00548990ImFITUpdated Jan 27, 2009

The Immune Function Intervention Trial

An interventional study of cardiovascular exercise training and flexibility/balance control in Immune Response, sponsored by National Institute on Aging (NIA). Completed at 1 site in United States. Open to participants aged 62 Years to 82 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-27.

Sponsored by National Institute on Aging (NIA) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
62 Years to 82 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Immune Response
03

In context

Lead sponsor

National Institute on Aging (NIA) is the lead sponsor of 157 studies on the registry; 13 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
62 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
150 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralcardiovascular exercise training
  • Behavioralflexibility/balance control
06

What researchers measure

Primary outcomes

  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 outcomes

  1. cardiovascular fitness

  2. psychosocial outcomes

07

Study locations

1 site
  • University of Illinois at Urbana-Champaign
    Urbana, Illinois 61801, United States
08

References and documents

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. PubMed 11976191 ↗
  • 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. PubMed 10405985 ↗
  • 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. PubMed 12196490 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00548990
Lead sponsor
National Institute on Aging (NIA)
First posted
Oct 25, 2007
Start date
Aug 2002
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Jan 27, 2009

Study contacts

Jeffrey A. Woods, PhD
principal investigator · University of Illinois at Urbana-Champaign

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion