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A Physical Activity Program to Disrupt Sedentary Time in Older Latinos (PAIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04507464
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Ulf G. Bronas, University of Illinois at Chicago

Brief Summary:
To test the feasibility of an intervention designed to replace sedentary time with physical activity in older Latinos, delivered in their homes to improve cognitive function and brain connectivity.

Condition or disease Intervention/treatment Phase
Sedentary Behavior Cognitive Impairment Behavioral: Ecological Momentary Intervention Not Applicable

Detailed Description:
After being informed of the study and potential risks, all patients giving informed consent will undergo a focused phone interviews, followed by screening to determine eligibility. Participants that meet inclusion criteria will undergo baseline cognitive function testing via video (following NIH toolbox guidelines for remote cognitive function assessment), followed by a one week measurement of sedentary time using a physical activity monitor (actigraphy). At week 0, participants will be randomized into either a physical activity group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs at 6 weeks using the same measures as baseline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a pilot randomized, controlled trial of a 6-week intervention for feasibility. Outcome measures will be obtained at baseline and at 6-weeks. Behavior choices and preference data will be continuously captured during the intervention. We will randomize 80 older Latinos from the Chicago Latino community to either an ecological momentary intervention using fitbits (n=40) or to physical activity guidelines (n=40).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
Actual Study Start Date : November 2, 2020
Actual Primary Completion Date : April 2, 2022
Actual Study Completion Date : April 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ecological Momentary Intervention
Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.
Behavioral: Ecological Momentary Intervention
Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.
Other Name: Illumivu mEMA

No Intervention: Physical Activity Guidelines
Participants will be sent general guidelines for disruption of sedentary time.



Primary Outcome Measures :
  1. Sedentary Time [ Time Frame: Baseline to end of 6 weeks ]
    Change in sedentary time from baseline to 6 weeks follow up


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: Baseline to end of 6 weeks ]
    Change in cognitive function measures assessed through the NIH Toolbox from baseline to 6 weeks

  2. Feasibility and Acceptability [ Time Frame: End of 6 weeks ]
    Formative assessments of usage of the smartphone app and participants' behavioral choices



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no history of major head trauma
  • ownership of a smartphone
  • ability to make video calls

Exclusion Criteria:

  • Requires assistive ambulation;
  • Unstable angina,
  • Claudication
  • severe arthritis,
  • extreme dyspnea on exertion,
  • Class III-IV heart failure;
  • Current uncontrolled sustained arrhythmias,
  • severe/symptomatic aortic or mitral stenosis,
  • hypertrophic obstructive cardiomyopathy,
  • severe pulmonary hypertension,
  • active myocarditis/pericarditis,
  • thrombophlebitis,
  • recent systemic/pulmonary embolus (within 3 months);
  • Revascularization procedures within the previous 6 months;
  • Pregnancy

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): NCT04507464


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Ulf G Bronas, PhD University of Illinois at Chicago
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Responsible Party: Ulf G. Bronas, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04507464    
Other Study ID Numbers: 2020-0739
2P30AG022849-16 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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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 Ulf G. Bronas, University of Illinois at Chicago:
Sedentary Behavior
Physical Activity
Cognitive Health
Older Adults
Latinos
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders