Full Text View
Tabular View
No Study Results Posted
Related Studies
Life 2: Improving Fitness and Function in Elders (Project LIFE)
This study has been completed.
First Received: February 12, 2007   Last Updated: February 4, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00435188
  Purpose

The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.


Condition Intervention Phase
Aging
Disability
Mobility Limitations
Behavioral: Multi-component physical activity counseling program
Phase II
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Life 2: Improving Fitness and Function in Elders

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • change in gait speed, usual and rapid [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in reported physical activity (CHAMPS questionnaire) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • change in self-report of physical function and disability (SF-36 Physical function scale, SF-36, question 1 overall health related quality of life, Late Life Function and disability Index) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • change in tests of physical performance (Short physical performance battery, 400 meter walk, grip strength) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • change in self-efficacy and motivation for physical activity [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Random assignment to a one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
Behavioral: Multi-component physical activity counseling program
A onr-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
2: No Intervention
Usual care

Detailed Description:

Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability. Rates of physical inactivity are highest among older adults. Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function. Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations. The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed. Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life. We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA. Design. Randomized controlled clinical trial. Data collection. All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year. The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality. Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals. Differences between groups for non-routine outpatient clinic use and hospitalization will be explored. The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups. Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components. We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy. Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs. Duration Four years. Relevance to the VA. Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)

Exclusion Criteria:

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)
  • A terminal diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435188

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Miriam C. Morey, PhD Department of Veterans Affairs
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs ( Morey, Miriam - Principal Investigator )
Study ID Numbers: E3386R
Study First Received: February 12, 2007
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00435188     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aging
Cost analysis
Counseling
Disabled Persons
Health Promotion
Mobility Limitation
Physical Activity
Primary Care
Randomized Clinical Trial
Veterans

Study placed in the following topic categories:
Mobility Limitation
Signs and Symptoms

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms

ClinicalTrials.gov processed this record on May 07, 2009