Clinical Trial: Life 2: Improving Fitness and Function in Elders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Life 2: Improving Fitness and Function in Elders

Brief Summary: 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.

Detailed Summary: 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 couns
Sponsor: VA Office of Research and Development

Current Primary Outcome:

  • Usual Gait Speed [ Time Frame: Baseline ]
    Best of two trials over 8-foot walk
  • Usual Gait Speed [ Time Frame: 3 month ]
  • Usual Gait Speed [ Time Frame: 12-month ]
  • Rapid Gait Speed [ Time Frame: Baseline ]
  • Rapid Gait Speed [ Time Frame: 3-month ]
  • Rapid Gait Speed [ Time Frame: 12-month ]


Original Primary Outcome: Change in gait speed between groups at 12 months

Current Secondary Outcome:

  • Physical Activity Frequency (CHAMPS Questionnaire) [ Time Frame: Baseline ]
    Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
  • Physical Activity Frequency (CHAMPS Questionnaire) [ Time Frame: 3 month ]
    Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
  • Physical Activity Frequency (CHAMPS Questionnaire) [ Time Frame: 12 month ]
    Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
  • Self Rated Health [ Time Frame: Baseline ]
    Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
  • Self Rated Health [ Time Frame: 3 month ]
    Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
  • Self Rated Health [ Time Frame: 12 month ]
    Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
  • Sf-36 Physical Function Subscale [ Time Frame: Baseline ]
    This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
  • Sf-36 Physical Function Subscale [ Time Frame: 3 month ]
    This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
  • Sf-36 Physical Function Subscale [ Time Frame: 12 month ]
    This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
  • 2 Minute Walk [ Time Frame: Baseline ]
    Distance walked in two minutes in meters
  • 2 Minute Walk [ Time Frame: 3 month ]
    Distance walked in two minutes in meters
  • 2 Minute Walk [ Time Frame: 12 month ]
    Distance walked in two minutes in meters


Original Secondary Outcome:

  • Examination of the effect of intervention between the two groups
  • (intervention and usual care) on physical activity, physical
  • performance, self-reported physical function, self-efficacy,
  • motivation, 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


Information By: VA Office of Research and Development

Dates:
Date Received: February 12, 2007
Date Started: November 2004
Date Completion:
Last Updated: January 8, 2015
Last Verified: January 2015