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The Immune Function Intervention Trial

Not Applicable
Completed
Conditions
Immune Response
Interventions
Behavioral: flexibility/balance control
Behavioral: cardiovascular exercise training
Registration Number
NCT00548990
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2flexibility/balance controlflexibility/balance control group
1cardiovascular exercise traininga 10-month moderate aerobic exercise training program
Primary Outcome Measures
NameTimeMethod
antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigensbaseline, 6 and 10 months
Secondary Outcome Measures
NameTimeMethod
cardiovascular fitness
psychosocial outcomes

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign

🇺🇸

Urbana, Illinois, United States

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