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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2021

Detailed Description

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.

Interventions

  • Behavioral: Smart Aging Program
    • 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.
  • Behavioral: Educational Materials
    • Current standard of care. Includes education materials covering benefits of a healthy lifestyle.

Arms, Groups and Cohorts

  • Experimental: Smart Aging Program
    • Participants will be enrolled into the Smart Aging Program.
  • Active Comparator: Control Group
    • Participants will be enrolled into group that receives educational materials that reflect the current standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Cardiorespiratory Fitness
    • Time Frame: Change from Baseline to 12 Weeks
    • Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
  • Change in Cardiorespiratory Fitness
    • Time Frame: Change from Baseline to 52 Weeks
    • Measured by peak oxygen consumption (VO2 peak) during treadmill testing.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey Burns, MD, Principal Investigator, University of Kansas Medical Center

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