NCT00548990

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

January 27, 2009

Status Verified

January 1, 2009

Enrollment Period

3.9 years

First QC Date

October 24, 2007

Last Update Submit

January 23, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens

    baseline, 6 and 10 months

Secondary Outcomes (2)

  • cardiovascular fitness

  • psychosocial outcomes

Study Arms (2)

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

Interventions

Eligibility Criteria

Age62 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (3)

  • 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. doi: 10.1111/j.1749-6632.2002.tb02088.x.

    PMID: 11976191BACKGROUND
  • 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. doi: 10.1016/s0047-6374(99)00014-7.

    PMID: 10405985BACKGROUND
  • 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. doi: 10.1093/gerona/57.9.m557.

    PMID: 12196490BACKGROUND

MeSH Terms

Interventions

Pliability

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Jeffrey A. Woods, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

August 1, 2002

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

January 27, 2009

Record last verified: 2009-01

Locations