CompletedNot Applicable

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

United States234 participantsStarted 2021-08-27

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

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline Physical Activity Frequency at 3 months

Timeframe: 12 weeks

Change from Baseline Physical Activity Frequency at 6 months

Timeframe: 24 weeks

Change from Baseline Physical Activity Frequency at 12 months

Timeframe: 48 weeks

Change from Baseline Physical Activity Intensity at 3 months

Timeframe: 12 weeks

Change from Baseline Physical Activity Intensity at 6 months

Timeframe: 24 weeks

Change from Baseline Physical Activity Intensity at 12 months

Timeframe: 48 weeks

Change from Baseline Physical Activity Duration at 3 months

Timeframe: 12 weeks

Trial details

NCT IDNCT05030948

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Mild Cognitive Impairment trials

Plain-language summary

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline Physical Activity Frequency at 3 months

Timeframe: 12 weeks

Change from Baseline Physical Activity Frequency at 6 months

Timeframe: 24 weeks

Change from Baseline Physical Activity Frequency at 12 months

Timeframe: 48 weeks

Change from Baseline Physical Activity Intensity at 3 months

Timeframe: 12 weeks

Change from Baseline Physical Activity Intensity at 6 months

Timeframe: 24 weeks

Change from Baseline Physical Activity Intensity at 12 months

Timeframe: 48 weeks

Change from Baseline Physical Activity Duration at 3 months

Timeframe: 12 weeks