The Immune Function Intervention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Immune Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

a 10-month moderate aerobic exercise training program

Group Type EXPERIMENTAL

cardiovascular exercise training

Intervention Type BEHAVIORAL

2

flexibility/balance control group

Group Type PLACEBO_COMPARATOR

flexibility/balance control

Intervention Type BEHAVIORAL

Interventions

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cardiovascular exercise training

Intervention Type BEHAVIORAL

flexibility/balance control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

62 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes