Clinical trial NCT04507464: A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
Official title: A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Cognitive Impairment
Keywords: Sedentary Behavior
Physical Activity
Cognitive Health
Older Adults
Latinos
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-08-11
Enrollment: 39
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Sedentary Bouts
timeFrame: Baseline, 6 weeks
measure: Time in Sedentary Bouts
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Trail Making Test A
timeFrame: Baseline, 6 weeks
measure: Trail Making Test B
timeFrame: baseline, 6 weeks
measure: Picture Vocabulary Test
timeFrame: Baseline, 6 weeks
measure: List Sorting
timeFrame: Baseline, 6 weeks
measure: Picture Sequence
timeFrame: Baseline, 6 weeks
measure: Oral Reading Recognition Test
timeFrame: Baseline, 6 weeks
measure: Crystalized Cognition
timeFrame: Baseline, 6 weeks
measure: Auditory Verbal Learning
timeFrame: Baseline, 6 weeks
measure: Text Message Motivation.
timeFrame: 6 weeks.
measure: Enjoyment of the Text Messages.
timeFrame: 6 weeks.
measure: Text Messages Helping Exercise.
timeFrame: 6 weeks.
measure: Difficulty Understanding Text Messages
timeFrame: 6 weeks
measure: Enjoyment of the Program.
timeFrame: 6 weeks.
measure: Difficulty With the FitBit.
timeFrame: 6 weeks.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Ulf G Bronas, PhD
role: PRINCIPAL_INVESTIGATOR
References: