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 TextMorey 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.
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