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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00548990
Other study ID # AG0088
Secondary ID NIH R01 AG-18861
Status Completed
Phase N/A
First received October 24, 2007
Last updated January 23, 2009
Start date August 2002
Est. completion date July 2006

Study information

Verified date January 2009
Source National Institute on Aging (NIA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 62 Years to 82 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
cardiovascular exercise training

flexibility/balance control


Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens baseline, 6 and 10 months
Secondary cardiovascular fitness
Secondary psychosocial outcomes
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