236 Participants Needed

Physical Activity Intervention for Cognitive Impairment

GA
NS
NA
NB
AV
Overseen ByAntonia Villarruel, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a program called Tiempo Juntos para la Salud that encourages moderate physical activity. It targets Spanish-speaking Latinos aged 55+ with mild memory issues. The goal is to improve their heart health, sleep, and brain function through regular exercise.

Research Team

GA

Gloria A Perez, PhD, CRNP

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for Spanish-speaking Latinos aged 55 or older with mild cognitive impairment, who lead a sedentary lifestyle (less than 150 minutes of activity per week). They must be able to consent and attend sessions, have access to a phone, and score between 23-26 on the MoCA test. Those with mobility disabilities or musculoskeletal issues preventing moderate physical activity cannot join.

Inclusion Criteria

Engages in less than 150 minutes of activity per week (sedentary)
Can provide informed consent
I am 55 years old or older.
See 5 more

Exclusion Criteria

Cannot provide informed consent
I have difficulty moving around on my own.
I have a condition that stops me from doing moderate exercise.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial data collection and baseline assessment of participants

1 week
1 visit (in-person)

Intervention

Participants engage in weekly 1-hour group sessions twice a week for 3 months, focusing on moderate-intensity physical activity or health education

12 weeks
24 visits (in-person or remote)

Booster Sessions

Participants receive motivational or educational booster sessions every other week via phone calls/text messaging

12 weeks

Follow-up

Participants are monitored for changes in physical activity, cardiovascular health, sleep, and cognitive function

24 weeks
3 visits (in-person)

Treatment Details

Interventions

  • Tiempo Juntos Intervention
Trial OverviewThe Tiempo Juntos Intervention aims to encourage moderate-intensity physical activity among participants. The study will also explore how this intervention affects cardiovascular health, sleep quality, and cognitive function over one year with assessments at baseline, then at 3, 6, and 12 months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Tiempo Juntos InterventionExperimental Treatment1 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. 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.
Group II: Attention ControlActive Control1 Intervention
If assigned to this group, participants will take part in 1-hour group (5-6 participants) sessions delivered twice a week for 3 months. The sessions will be with a trained Community Health Worker or qualified staff that will involve reviewing education topics in Spanish related to adult health. They will take place at community partner sites or remotely during times when all participants can attend. In case of adverse weather, indoor locations, or remote options will be available. Upon completing the 3 months of education sessions, for the next 3 months, they will receive educational "booster" sessions delivered every other week via phone calls/text messaging.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+