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Clinical Trials/NCT03253341
NCT03253341CompletedNot Applicable

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

University of Kansas Medical Center1 site in 1 country219 target enrollmentStarted: July 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
219
Locations
1
Primary Endpoint
Change in Cardiorespiratory Fitness

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Smart Aging Program

Experimental

Participants will be enrolled into the Smart Aging Program.

Intervention: Smart Aging Program (Behavioral)

Control Group

Active Comparator

Participants will be enrolled into group that receives educational materials that reflect the current standard of care.

Intervention: Educational Materials (Behavioral)

Outcomes

Primary Outcomes

Change in Cardiorespiratory Fitness

Time Frame: Change from Baseline to 52 Weeks

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

Change in Cardiorespiratory Fitness

Time Frame: Change from Baseline to 12 Weeks

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

Secondary Outcomes

  • Changes in Insulin Resistance(52 Weeks)
  • Change in Cholesterol(52 Weeks)
  • Change in Fat Mass(52 Weeks)
  • Change in Lean Mass(52 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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