The Immune Function Intervention Trial (ImFIT)

National Institutes of Health (NIH)

Status: Completed

Conditions: Immune Response

Treatments: Behavioral: cardiovascular exercise training; Behavioral: flexibility/balance control

Study type: Interventional

Funder types: NIH

Identifiers

NCT00548990

AG0088

NIH R01 AG-18861

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 62 to 82 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

a 10-month moderate aerobic exercise training program

Treatment:

Behavioral: cardiovascular exercise training

2

Placebo Comparator group

Description:

flexibility/balance control group

Treatment:

Behavioral: flexibility/balance control