ClinicalTrials.gg
CompletedNCT03253341Updated Sep 14, 2023

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

An interventional study of Smart Aging Program and Educational Materials in Aging and Health Behavior, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
219
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 421 studies in Health Behavior with a site in United States — 66 open to participants now, 86 under way, 1 of them phase 3. Health Behavior · United States.

Enrollment
161st of 385
219 · median 130
Started
2018
with 24 others
No phase
363 of 421
58 open now
Registered
142nd of 421
by date

Among the 421 studies in Health Behavior with a site in United States, this one is the 161st largest by enrollment of the 385 interventional ones that give a count, is one of 25 that started in 2018, is one of 363 with no phase, and was the 142nd registered.

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

Browse Health Behavior studies →

Open to participants now

66 of the 421 studies in Health Behavior with a site in United States are open now. Recruiting first, the newest first:

61 more — sign in →

All 66 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.

This study: 65 Years and older · all sexes · healthy volunteers too.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Aging
  • Health Behavior

Browse trials for

Keywords

  • exercise program
  • lifestyle changes
  • fitness program
  • lifestyle intervention
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ) in the last 6 months
  • Cancer diagnosis in the last 2 years (except non- 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
219 participants (actual)

Study arms

  • Experimental
    Smart Aging Program

    Participants will be enrolled into the Smart Aging Program.

    Behavioral: Smart Aging Program

  • Active comparator
    Control Group

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

    Behavioral: Educational Materials

Interventions

  • BehavioralSmart 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.

  • BehavioralEducational Materials

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

06

What researchers measure

Primary outcomes

  1. Change in Cardiorespiratory Fitness

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

    Time frame: Change from Baseline to 12 Weeks

  2. Change in Cardiorespiratory Fitness

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

    Time frame: Change from Baseline to 52 Weeks

Secondary outcomes

  1. Changes in Insulin Resistance

    Measured using Homeostasis Model Assessment 2.

    Time frame: 52 Weeks

  2. Change in Fat Mass

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

    Time frame: 52 Weeks

  3. Change in Lean Mass

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

    Time frame: 52 Weeks

  4. Change in Cholesterol

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

    Time frame: 52 Weeks

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Jun 2021, 35 months.

Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 35 months is above that.

Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2017
First posted
Aug 17, 2017
StartActual
Jul 1, 2018
Primary completionActual
Jun 1, 2021
CompletionActual
Aug 1, 2023
Last update
Sep 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03253341
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Jul 1, 2018
Primary completion
Jun 1, 2021
Completion
Aug 1, 2023
Last update
Sep 14, 2023

Study contacts

Jeffrey Burns, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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