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

NCT ID: NCT03253341

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Aging Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smart Aging Program

Participants will be enrolled into the Smart Aging Program.

Group Type EXPERIMENTAL

Smart Aging Program

Intervention Type 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.

Control Group

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

Group Type ACTIVE_COMPARATOR

Educational Materials

Intervention Type BEHAVIORAL

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

Interventions

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Smart 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.

Intervention Type BEHAVIORAL

Educational Materials

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Burns, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39376152 (View on PubMed)

Other Identifiers

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Smart Aging Program

Identifier Type: -

Identifier Source: org_study_id

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