Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy of delivering an exercise and healthy lifestyle program, Smart Aging, to older adults.

Detailed Description
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The Smart Aging Program is designed to be scalable, implementable, and sustainable in the real world. This program joins patients and their clinicians with community-based fitness centers. The Smart Aging Program looks to use already existing resources to deliver an innovative program to increase physical activity in older adults. The program begins at the patient-physician level. The program is conducted in community-based fitness centers, the participant's home (home exercise, monitoring) and also sends physical activity data back to the clinician using mobile technology. The Smart Aging Program consists of a personalized and structured exercise program combined with lifestyle education and mobile-health monitoring. The exercise program includes a 12-week initiation phase, followed by a 40-week maintenance phase.

Official Title
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Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions

Conditions
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Aging, Health Behavior

Intervention / Treatment
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* Behavioral: Smart Aging Program
* Behavioral: Educational Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinician referred Ambulatory: walk unassisted and successfully complete the 6 minute walk test without rest Sufficiently fluent in English to participate in study procedures Sedentary or underactive by the Telephone Assessment of Physical Activity61 Exclusion Criteria: Clinically-significant systemic or psychiatric illness that may affect safety or completion Diagnosis of dementia; use of dementia medications (cholinesterase inhibitors, memantine) Myocardial infarction or unstable coronary artery disease (e.g., angina, arrhythmia) in last 6 months. Cerebrovascular event (stroke or transient ischemic attack) in the last 6 months Cancer diagnosis in the last 2 years (except non-metastatic basal or squamous cell carcinoma or cancer in remission in the absence of treatment for at least 2 years) Significant pain or musculoskeletal disorder limiting the ability to participate safely Another member of the household enrolled in the study

Ages Eligible for Study
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Minimum Age: 65 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: Smart Aging Program<br>Participants will be enrolled into the Smart Aging Program. | Behavioral: Smart Aging Program<br>* Comprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities.<br>|
| Active Comparator: Control Group<br>Participants will be enrolled into group that receives educational materials that reflect the current standard of care. | Behavioral: Educational Materials<br>* Current standard of care. Includes education materials covering benefits of a healthy lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiorespiratory Fitness | Measured by peak oxygen consumption (VO2 peak) during treadmill testing. | Change from Baseline to 12 Weeks | 
| Change in Cardiorespiratory Fitness | Measured by peak oxygen consumption (VO2 peak) during treadmill testing. | Change from Baseline to 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Insulin Resistance | Measured using Homeostasis Model Assessment 2. | 52 Weeks | 
| Change in Fat Mass | Measured using a dual energy x-ray absorptiometry (DEXA) scan. | 52 Weeks | 
| Change in Lean Mass | Measured using a dual energy x-ray absorptiometry (DEXA) scan. | 52 Weeks | 
| Change in Cholesterol | Changes in total cholesterol, LDL, and HDL will be measured. | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise program, lifestyle changes, fitness program, lifestyle intervention