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

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ClinicalTrials.gov Identifier: NCT03253341
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Aging Health Behavior Behavioral: Smart Aging Program Behavioral: Educational Materials Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Experimental: Smart Aging Program
Participants will be enrolled into the Smart Aging Program.
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.

Active Comparator: Control Group
Participants will be enrolled into group that receives educational materials that reflect the current standard of care.
Behavioral: Educational Materials
Current standard of care. Includes education materials covering benefits of a healthy lifestyle.




Primary Outcome Measures :
  1. Change in Cardiorespiratory Fitness [ Time Frame: Change from Baseline to 12 Weeks ]
    Measured by peak oxygen consumption (VO2 peak) during treadmill testing.

  2. Change in Cardiorespiratory Fitness [ Time Frame: Change from Baseline to 52 Weeks ]
    Measured by peak oxygen consumption (VO2 peak) during treadmill testing.


Secondary Outcome Measures :
  1. Changes in Insulin Resistance [ Time Frame: 52 Weeks ]
    Measured using Homeostasis Model Assessment 2.

  2. Change in Fat Mass [ Time Frame: 52 Weeks ]
    Measured using a dual energy x-ray absorptiometry (DEXA) scan.

  3. Change in Lean Mass [ Time Frame: 52 Weeks ]
    Measured using a dual energy x-ray absorptiometry (DEXA) scan.

  4. Change in Cholesterol [ Time Frame: 52 Weeks ]
    Changes in total cholesterol, LDL, and HDL will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253341


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Jeffrey Burns, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03253341     History of Changes
Other Study ID Numbers: Smart Aging Program
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
exercise program
lifestyle changes
fitness program
lifestyle intervention