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OpenTrials
Completed

NCT Number: NCT03253341

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart Aging Program

Behavioral

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.

Educational materials

Behavioral

Current standard of care. Includes education materials covering benefits of a healthy lifestyle.

Primary outcomes

  1. Change in Cardiorespiratory Fitness

    Time frame: Change from Baseline to 12 Weeks

    Measured by peak oxygen consumption (VO2 peak) during treadmill testing.

  2. Change in Cardiorespiratory Fitness

    Time frame: Change from Baseline to 52 Weeks

    Measured by peak oxygen consumption (VO2 peak) during treadmill testing.

Secondary outcomes

  1. Changes in Insulin Resistance

    Time frame: 52 Weeks

    Measured using Homeostasis Model Assessment 2.

  2. Change in Fat Mass

    Time frame: 52 Weeks

    Measured using a dual energy x-ray absorptiometry (DEXA) scan.

  3. Change in Lean Mass

    Time frame: 52 Weeks

    Measured using a dual energy x-ray absorptiometry (DEXA) scan.

  4. Change in Cholesterol

    Time frame: 52 Weeks

    Changes in total cholesterol, LDL, and HDL will be measured.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Aug 17, 2017
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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