Identifying and Treating Physical Function Impairment in Elders

Study Overview
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Brief Summary
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Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings. Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function. Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group. Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group. Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation

Official Title
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Identifying and Treating Physical Function Impairment in Elders

Conditions
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Physical Activity, Physical Impairment

Intervention / Treatment
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* Behavioral: Behavioral Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling) Exclusion Criteria: Inability to walk ≥30 feet without human assistance7 Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment Severe vision loss (legally blind) Severe hearing loss Medical condition that precludes increasing physical activity per primary care provider's assessment Terminal diagnosis per primary care provider's assessment

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br>Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers | Behavioral: Behavioral Counseling<br> <br> |
| No Intervention: Usual Care<br>Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic). No behavioral counseling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in physical activity as determined by accelerometer | Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention. | 12 weeks | 
| Changes in physical function as assessed by 400-meter walk speed | Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention. | 12 weeks | 
| Changes in physical function as assessed by Short Physical Performance Battery | Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention | 12 weeks | 
| Change in physical function as assessed by lower extremity strength testing | Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention . | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of standard implementation science process of reach | Reach is the percent of patients consented divided by the number eligible. | 1 year | 
| Assessment of standard implementation science process metrics of acceptability | Acceptability will be assessed through structured surveys. | 1 year | 
| Assessment of standard implementation science process metrics of implementation | Implementation process will be assessed by structured surveys | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, Elderly