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

Not Applicable

Completed

• Conditions: Aging; Health Behavior
• Interventions: Behavioral: Educational Materials; Behavioral: Smart Aging Program

• Registration Number: NCT03253341
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-17
• Study Start: 2018-07-01
• Primary Completion: 2021-06-01
• Study Completion: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Educational Materials	Participants will be enrolled into group that receives educational materials that reflect the current standard of care.
Smart Aging Program	Smart Aging Program	Participants will be enrolled into the Smart Aging Program.

Primary Outcome Measures

Name	Time	Method
Change in Cardiorespiratory Fitness	Change from Baseline to 52 Weeks	Measured by peak oxygen consumption (VO2 peak) during treadmill testing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States