Life 2: Improving Fitness and Function in Elders

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Life 2: Improving Fitness and Function in Elders

Conditions
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Aging, Mobility Limitations

Intervention / Treatment
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* Behavioral: Multi-component physical activity counseling program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Behavioral: Multi-component physical activity counseling program 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<br>* 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<br>|
| No Intervention: Arm 2<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usual Gait Speed | Best of two trials over 8-foot walk | Baseline | 
| Usual Gait Speed |  | 3 month | 
| Usual Gait Speed |  | 12-month | 
| Rapid Gait Speed |  | Baseline | 
| Rapid Gait Speed |  | 3-month | 
| Rapid Gait Speed |  | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Frequency (CHAMPS Questionnaire) | Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities | Baseline | 
| Physical Activity Frequency (CHAMPS Questionnaire) | 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 month | 
| Physical Activity Frequency (CHAMPS Questionnaire) | Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities | 12 month | 
| Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | Baseline | 
| Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | 3 month | 
| Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | 12 month | 
| Sf-36 Physical Function Subscale | 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. | Baseline | 
| Sf-36 Physical Function Subscale | 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. | 3 month | 
| Sf-36 Physical Function Subscale | 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. | 12 month | 
| 2 Minute Walk | Distance walked in two minutes in meters | Baseline | 
| 2 Minute Walk | Distance walked in two minutes in meters | 3 month | 
| 2 Minute Walk | Distance walked in two minutes in meters | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Cost analysis, Counseling, Disabled Persons, Health Promotion, Mobility Limitation, Physical Activity, Primary Care, Randomized Clinical Trial, Veterans