Clinical trial NCT03253341: Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
Official title: Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Health Behavior
Keywords: exercise program
lifestyle changes
fitness program
lifestyle intervention
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 219
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cardiorespiratory Fitness
timeFrame: Change from Baseline to 12 Weeks
measure: Change in Cardiorespiratory Fitness
timeFrame: Change from Baseline to 52 Weeks
Secondary outcomes:
measure: Changes in Insulin Resistance
timeFrame: 52 Weeks
measure: Change in Fat Mass
timeFrame: 52 Weeks
measure: Change in Lean Mass
timeFrame: 52 Weeks
measure: Change in Cholesterol
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Burns, MD
role: PRINCIPAL_INVESTIGATOR
References: