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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253341
• Other study ID #: Smart Aging Program
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Health Behavior

Intervention

Behavioral:
• 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.
• Educational Materials
Current standard of care. Includes education materials covering benefits of a healthy lifestyle.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiorespiratory Fitness	Measured by peak oxygen consumption (VO2 peak) during treadmill testing.	Change from Baseline to 12 Weeks
Primary	Change in Cardiorespiratory Fitness	Measured by peak oxygen consumption (VO2 peak) during treadmill testing.	Change from Baseline to 52 Weeks
Secondary	Changes in Insulin Resistance	Measured using Homeostasis Model Assessment 2.	52 Weeks
Secondary	Change in Fat Mass	Measured using a dual energy x-ray absorptiometry (DEXA) scan.	52 Weeks
Secondary	Change in Lean Mass	Measured using a dual energy x-ray absorptiometry (DEXA) scan.	52 Weeks
Secondary	Change in Cholesterol	Changes in total cholesterol, LDL, and HDL will be measured.	52 Weeks