Suspended

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

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What is being tested

Tiempo Juntos Intervention

Behavioral
Who is being recruted

Behavior+8

+ Mental Disorders

+ Cognition Disorders

Over 55 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: August 2021
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 27, 2021

Actual date on which the first participant was enrolled.

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) \[Montreal Cognitive Assessment (MoCA) score 23 to 26 for Latino populations\].

Official TitleA Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
NCT05030948
Principal SponsorUniversity of Pennsylvania
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

236 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersCognition DisordersSleep Initiation and Maintenance DisordersMotor ActivityNervous System DiseasesSleep Wake DisordersNeurocognitive DisordersSleep Disorders, IntrinsicDyssomniasCognitive Dysfunction

Criteria

8 inclusion criteria required to participate
Can provide informed consent
55+ years
Self-identify as Hispanic/Latino
Spanish as primary language
Show More Criteria
3 exclusion criteria prevent from participating
Cannot provide informed consent
Mobility disability
Musculoskeletal problem / co-morbidity (prevents moderate PA)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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. They will take place at community partner sites during times when all participants can attend. In case of adverse weather, indoor locations are available through community partners. Walks will reflect participant goals and abilities, initially lasting 10 minutes, with 5-minute stretching "warm-up" and 5-minute "cool down" exercises, for a total of 20 minutes. Walk duration will increase by 5 minutes/week to at least 30 minutes with program content delivery time decreasing to accommodate increased walk times within the 1-hour session. 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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Pennsylvania School of Nursing

Philadelphia, United StatesOpen University of Pennsylvania School of Nursing in Google Maps
SuspendedOne Study Center