A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos

Mild Cognitive Impairment Clinical Trial

Official title:

A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05030948
• Other study ID #: 844561
• Secondary ID: 1R01AG070351-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, single-blind, controlled trial that will test a multilevel intervention, Tiempo Juntos para la Salud, (Time Together for Health) designed to promote moderate-intensity physical activity; theoretically grounded mediators; and secondary outcomes of cardiovascular health, sleep and cognitive function. Participants will have 4 visits over a year long period. Data collection will occur at baseline, 3 months, 6 months, and 12 months among 216 Spanish language-dominant Latinos aged 55 and older with Mild Cognitive Impairment (MCI) [Montreal Cognitive Assessment (MoCA) score 23 to 26 for Latino populations].

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Can provide informed consent

• 55+ years

• Self-identify as Hispanic/Latino

• Spanish as primary language

• Willing to attend intervention / education sessions

• Access to phone/cell

• less than 150 min of activity / week (sedentary)

• Montreal Cognitive Assessment (MoCA) score (score = 23 to 26 for Latino populations)

Exclusion Criteria:

• Cannot provide informed consent

• Mobility disability

• Musculoskeletal problem / co-morbidity (prevents moderate PA)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Tiempo Juntos Intervention
If assigned to this group, participants will take part in weekly 1-hour group sessions twice a week for 3 months. The sessions will be with a trained Community Health Worker that will involve group (5-6 participants) moderate-intensity walking. Upon completing the 3 months of physical activity sessions, for the next 3 months, they will receive motivational "booster" sessions delivered every other week via phone calls/text messaging.

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Nursing	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Physical Activity Frequency at 3 months	Number of activity sessions	12 weeks
Primary	Change from Baseline Physical Activity Frequency at 6 months	Number of activity sessions	24 weeks
Primary	Change from Baseline Physical Activity Frequency at 12 months	Number of activity sessions	48 weeks
Primary	Change from Baseline Physical Activity Intensity at 3 months	Light, moderate, or vigorous (determined by counts per minute)	12 weeks
Primary	Change from Baseline Physical Activity Intensity at 6 months	Light, moderate, or vigorous (determined by counts per minute)	24 weeks
Primary	Change from Baseline Physical Activity Intensity at 12 months	Light, moderate, or vigorous (determined by counts per minute)	48 weeks
Primary	Change from Baseline Physical Activity Duration at 3 months	Total time spent in activity (hours and minutes)	12 weeks
Primary	Change from Baseline Physical Activity Duration at 6 months	Total time spent in activity (hours and minutes)	24 weeks
Primary	Change from Baseline Physical Activity Duration at 12 months	Total time spent in activity (hours and minutes)	48 weeks