Healia Clinical Trials Information Database

Life 2: Improving Fitness and Function in Elders

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.

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.

Status: Completed (Phase 2/Phase 3). Started on November 1st, 2004.

Enrollment: 400 subjects

Study Type: Interventional

Study Design:

  • Allocation: Randomized
  • Endpoint Classification: Efficacy Study
  • Intervention Model: Parallel Assignment
  • Masking: Open Label
  • Primary Purpose: Supportive Care

Conditions:

Interventions:

  • Behavioral: Multi-component physical activity counseling program

Eligibility

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

Gender

Both

Mininum Age

70 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: Department of Veterans Affairs

Authority: United States: Federal Government

Locations

  • VA Medical Center
    Durham
    North Carolina
    27705
    United States

Officials

  • Miriam C. Morey, PhD (Principal Investigator, Department of Veterans Affairs)

Sponsors

  • Department of Veterans Affairs (Lead Sponsor)

References

  • Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39.
    PMID: 19117329.
    Check for Full Text

  • Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91.
    PMID: 19436015.
    Check for Full Text

Links


Date Verified
September 1st, 2011
First Received
September 7th, 2011
Last Changed
September 7th, 2011

Information obtained from ClinicalTrials.gov on September 07, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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