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The Immune Function Intervention Trial

Physical Activity, Aging and Immune Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00548990
Acronym
ImFIT
Enrollment
150
Registered
2007-10-25
Start date
2002-08-31
Completion date
2006-07-31
Last updated
2009-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Response

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.

Interventions

BEHAVIORALflexibility/balance control

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
62 Years to 82 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigensbaseline, 6 and 10 months

Secondary

MeasureTime frame
cardiovascular fitness
psychosocial outcomes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026