The Immune Function Intervention Trial - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00548990

Purpose

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

Condition	Intervention
Immune Response	Behavioral: cardiovascular exercise training Behavioral: flexibility/balance control

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Official Title:	Physical Activity, Aging and Immune Function

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens [ Time Frame: baseline, 6 and 10 months ]

Secondary Outcome Measures:

cardiovascular fitness
psychosocial outcomes

Enrollment:	150
Study Start Date:	August 2002
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental a 10-month moderate aerobic exercise training program	Behavioral: cardiovascular exercise training
2: Placebo Comparator flexibility/balance control group	Behavioral: flexibility/balance control

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.

Eligibility

Ages Eligible for Study:	62 Years to 82 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548990

Locations

United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Jeffrey A. Woods, PhD

University of Illinois at Urbana-Champaign

More Information

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. Review.

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.

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.

Study ID Numbers:	AG0088, NIH R01 AG-18861
Study First Received:	October 24, 2007
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00548990 History of Changes
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on September 10, 2009