Physical Activity Intervention for Cognitive Impairment

Overseen By Antonia Villarruel, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Mobility disability, Musculoskeletal problem, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical activity, specifically through the Tiempo Juntos Intervention, can improve cognitive function, heart health, and sleep among older Latino adults who speak Spanish and have mild cognitive impairment. Participants will either join group walking sessions to promote physical activity or attend health education sessions. Suitable individuals exercise less than 150 minutes a week, are 55 or older, and identify as Hispanic/Latino. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance well-being in the community.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for promoting physical activity in older adults with cognitive impairment?

Research has shown that physical activity programs, such as the Tiempo Juntos program, are generally safe and manageable for participants. In previous studies on exercise programs for brain health, serious side effects were rare and typically mild, such as temporary muscle soreness. These programs often include moderate activities like walking, which have proven suitable for older adults, even those with mild memory problems. Tiempo Juntos is designed to gradually increase activity levels based on each person's comfort and ability, ensuring safety. This careful approach reduces risks and helps participants safely gain health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tiempo Juntos Intervention for cognitive impairment because it leverages social physical activity as a treatment method. Unlike standard treatments for cognitive decline, which often involve medications or cognitive exercises, this approach emphasizes group-based, moderate-intensity walking sessions that adapt to participant goals and abilities. The intervention not only promotes physical health but also fosters community support and engagement, which can be crucial for sustained motivation and mental well-being. Additionally, the inclusion of motivational "booster" sessions via phone calls or texts helps maintain long-term engagement and potentially enhances cognitive benefits beyond the initial 3-month program.

What evidence suggests that the Tiempo Juntos Intervention could be effective for cognitive impairment?

Research has shown that physical activity can improve thinking and memory, especially for people with Mild Cognitive Impairment (MCI). In this trial, participants in the Tiempo Juntos Intervention arm will engage in a structured physical activity program. Studies have found that combining exercise with mental challenges can enhance brain health. Specifically, one study discovered that a 24-month exercise program led to better thinking skills and a lower chance of developing dementia. Another study showed improvements in both brain function and heart health after a 12-week program. These findings suggest that such activities may benefit brain health. ^{1 6 7 8 9}

Who Is on the Research Team?

Gloria A Perez, PhD, CRNP

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Cannot provide informed consent

I have a condition that stops me from doing moderate exercise.

I have difficulty moving around on my own.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Tiempo Juntos Intervention

Trial Overview The 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.

How Is the Trial Designed?

Group I: Tiempo Juntos Intervention Experimental Treatment 1 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 Control Active Control 1 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.

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05030948

A Physical Activity Intervention to Promote Cognitive Health ... This study is a randomized, single-blind, controlled trial that will test a multilevel intervention, Tiempo Juntos para la Salud, (Time Together for Health) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11941773/

Combined Physical–Cognitive Therapies for the Health of ... This meta-analysis shows that combined physical exercise and cognitive stimulation interventions may be an effective strategy for improving cognitive health in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4698980/

Effect of a 24-month physical activity intervention compared to ... A 24-month physical activity program results in better cognitive function and/or lower risk of mild cognitive impairment (MCI) or dementia compared to a health ...

4. ouci.dntb.gov.ua ouci.dntb.gov.ua/en/works/7Aeoz5k7/

Effectiveness of Combined Cognitive and Physical ... The results revealed improvements in cognitive performance and cardiovascular fitness in both the W and W-COG groups after 12 weeks of intervention. However, ...

5. brainhealthdata.org brainhealthdata.org/wp-content/uploads/2021/07/Place-and-Brain-Health-Equity-Briefing-Slides.pdf

Place and Brain Health Equity Tiempo Juntos por Nuestra Salud. (Time Together for ... 1692) to improve early detection of cognitive impairment during the Medicare. Annual Wellness Visit.

6. ldi.upenn.edu ldi.upenn.edu/wp-content/uploads/2022/09/Tiempo-Juntos-Ashley-Duchi-SUMR-Presentation.pdf

Tiempo Juntos - Ashley Duchi SUMR Presentation - Penn LDI • Primary outcome: moderate- intensity physical activity. • Secondary outcomes: cognitive function, CV health and sleep. Page 8. Participants. • Spanish ...

7. nia.nih.gov nia.nih.gov/research/ongoing-AD-trials

NIA-Funded Active Alzheimer's and Related Dementias ... The National Institute on Aging (NIA) is currently supporting 495 active clinical trials on Alzheimer's disease and related dementias (AD/ADRD).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8394441/

Physical Activity Interventions and Their Effects on Cognitive ... The primary aim was to identify and summarize PA interventions and their effects on cognitive function among persons with dementia (PwD).

9. sprinttrial.org sprinttrial.org/

SPRINT Blood Pressure & Dementia Trial SPRINT is a two-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure to a ...