ImFIT: The Immune Function Intervention Trial

• Sponsor: National Institute on Aging (NIA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00548990
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Immune Response	Behavioral: cardiovascular exercise training; Behavioral: flexibility/balance control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Physical Activity, Aging and Immune Function
• Study Start Date: Aug 1, 2002
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 a 10-month moderate aerobic exercise training program	Behavioral: cardiovascular exercise training
Placebo Comparator: 2 flexibility/balance control group	Behavioral: flexibility/balance control

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. cardiovascular fitness []

2. psychosocial outcomes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 62 Years to 82 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00548990
• Other Study ID Numbers: AG0088; NIH R01 AG-18861
• First Posted: Oct 25, 2007
• Last Update Posted: Jan 27, 2009
• Last Verified: Jan 1, 2009

Study Results

No Results Posted as of Jan 27, 2009