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Clinical Trials/NCT04507464
NCT04507464CompletedNot Applicable

A Physical Activity Program to Disrupt Sedentary Time in Older Latinos

University of Illinois at Chicago1 site in 1 country39 target enrollmentStarted: November 2, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
1
Primary Endpoint
Time in Sedentary Bouts

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
55 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Ecological Momentary Intervention

Experimental

Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.

Intervention: Ecological Momentary Intervention (Behavioral)

Physical Activity Guidelines

No Intervention

Participants will be sent general guidelines for disruption of sedentary time.

Outcomes

Primary Outcomes

Time in Sedentary Bouts

Time Frame: Baseline, 6 weeks

Change from baseline to 6 weeks in minutes spent in sedentary bouts

Number of Sedentary Bouts

Time Frame: Baseline, 6 weeks

Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute. Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute

Secondary Outcomes

  • Difficulty Understanding Text Messages(6 weeks)
  • Difficulty With the FitBit.(6 weeks.)
  • Trail Making Test A(Baseline, 6 weeks)
  • List Sorting(Baseline, 6 weeks)
  • Enjoyment of the Text Messages.(6 weeks.)
  • Text Messages Helping Exercise.(6 weeks.)
  • Trail Making Test B(baseline, 6 weeks)
  • Picture Vocabulary Test(Baseline, 6 weeks)
  • Picture Sequence(Baseline, 6 weeks)
  • Oral Reading Recognition Test(Baseline, 6 weeks)
  • Auditory Verbal Learning(Baseline, 6 weeks)
  • Crystalized Cognition(Baseline, 6 weeks)
  • Text Message Motivation.(6 weeks.)
  • Enjoyment of the Program.(6 weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ulf G. Bronas

Associate Professor

University of Illinois at Chicago

Study Sites (1)

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