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OpenTrials
Completed

NCT Number: NCT00435188

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-component physical activity counseling program

Behavioral

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

Primary outcomes

  1. Usual Gait Speed

    Time frame: Baseline

    Best of two trials over 8-foot walk

  2. Usual Gait Speed

    Time frame: 3 month

  3. Usual Gait Speed

    Time frame: 12-month

  4. Rapid Gait Speed

    Time frame: Baseline

  5. Rapid Gait Speed

    Time frame: 3-month

  6. Rapid Gait Speed

    Time frame: 12-month

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Self Rated Health

    Time frame: Baseline

    Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 2 Minute Walk

    Time frame: Baseline

    Distance walked in two minutes in meters

  11. 2 Minute Walk

    Time frame: 3 month

    Distance walked in two minutes in meters

  12. 2 Minute Walk

    Time frame: 12 month

    Distance walked in two minutes in meters

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Acronym: Project LIFE

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 14, 2007
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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