NCT03253341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

August 15, 2017

Last Update Submit

September 12, 2023

Conditions

AgingHealth Behavior

Keywords

exercise programlifestyle changesfitness programlifestyle intervention

Outcome Measures

Primary Outcomes (2)

  • Change in Cardiorespiratory Fitness

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

    Change from Baseline to 12 Weeks

  • Change in Cardiorespiratory Fitness

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

    Change from Baseline to 52 Weeks

Secondary Outcomes (4)

  • Changes in Insulin Resistance

    52 Weeks

  • Change in Fat Mass

    52 Weeks

  • Change in Lean Mass

    52 Weeks

  • Change in Cholesterol

    52 Weeks

Study Arms (2)

Smart Aging Program

EXPERIMENTAL

Participants will be enrolled into the Smart Aging Program.

Behavioral: Smart Aging Program

Control Group

ACTIVE COMPARATOR

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

Behavioral: Educational Materials

Interventions

Smart Aging ProgramBEHAVIORAL

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.

Smart Aging Program
Educational MaterialsBEHAVIORAL

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

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • Holden R, Szabo-Reed AN, Watts A, Clutton J, Finley K, Wolff SF, Burns JM. Physician referral is associated with recruitment, motivation, and adherence in an exercise intervention study for older adults. J Natl Med Assoc. 2025 Nov 15:S0027-9684(25)00342-6. doi: 10.1016/j.jnma.2025.11.002. Online ahead of print.

    PMID: 41298205DERIVED

  • Watts A, Szabo-Reed A, Baker J, Morris JK, Vacek J, Clutton J, Mahnken J, Key MN, Vidoni ED, Burns JM. LEAP! Rx: A randomized trial of a pragmatic approach to lifestyle medicine. Alzheimers Dement. 2024 Dec;20(12):8374-8386. doi: 10.1002/alz.14265. Epub 2024 Oct 8.

    PMID: 39376152DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jeffrey Burns, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 17, 2017

Study Start

July 1, 2018

Primary Completion

June 1, 2021

Study Completion

August 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

US(1)