What is the mechanism of action of this treatment?

Moderate-intensity physical activity, as promoted in the Tiempo Juntos para la Salud trial, improves cardiovascular health by enhancing blood flow and reducing risk factors such as hypertension and dyslipidemia. Improved cardiovascular health ensures better oxygen and nutrient delivery to the brain, which is crucial for maintaining cognitive function. Physical activity also positively impacts sleep by regulating circadian rhythms and reducing sleep disturbances, which are common in MCI patients. Better sleep quality is associated with improved memory consolidation and cognitive performance. These combined effects help slow the progression of cognitive decline in MCI patients, making physical activity a vital component of their treatment plan.

What side effects are associated with this type of intervention?

Moderate-intensity physical activity, as promoted in the Tiempo Juntos para la Salud trial, generally has minimal side effects. Common side effects may include muscle soreness, fatigue, and a temporary increase in heart rate. These effects are typically mild and transient. In contrast, pharmacological treatments for MCI, such as cognition enhancers (e.g., piracetam, acetyl-L-carnitine, nimodipine), may have side effects including gastrointestinal issues, headaches, and dizziness. It is important to consult with a healthcare provider to tailor the treatment plan to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs for the treatment of Mild Cognitive Impairment (MCI). However, some treatments for Alzheimer's disease, such as cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine), are sometimes used off-label for MCI. The Tiempo Juntos para la Salud trial focuses on non-pharmacological interventions, specifically promoting moderate-intensity physical activity to improve cardiovascular health, sleep, and cognitive function, which aligns with broader recommendations for lifestyle modifications to manage MCI.

What other types of research exist?

<ol> <li>Dance Therapy Programs: Programs like the flamenco and sevillanas dance therapy have shown improvements in physical activity, balance, and quality of life, which could be beneficial for MCI patients.</li> <li>MIND Diet: Adherence to the MIND diet has been associated with better physical function and grip strength, which may indirectly support cognitive health.</li> <li>BAILAMOS Dance Program: This program has shown potential in increasing hippocampal volume and physical activity, which are crucial for cognitive health.</li> <li>Multidisciplinary Rehabilitation: Combining physical therapy, occupational therapy, and mindfulness-based interventions can address multiple aspects of health, including cognitive function and cardiovascular health.</li> </ol>

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Physical Activity Intervention for Cognitive Impairment

N/A

Waitlist Available

Led By Gloria A Perez, PhD, CRNP

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 55 years and above

Be older than 18 years old

Must not have

Mobility disability

Musculoskeletal problem or co-morbidity that prevents moderate physical activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention promotes physical activity rather than medication use, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However specific side effects are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have difficulty moving around on my own.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Physical Activity Duration at 12 months

Change from Baseline Physical Activity Duration at 3 months

Change from Baseline Physical Activity Duration at 6 months

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Moderate-intensity physical activity, as promoted in the Tiempo Juntos para la Salud trial, improves cardiovascular health by enhancing blood flow and reducing risk factors such as hypertension and dyslipidemia. Improved cardiovascular health ensures better oxygen and nutrient delivery to the brain, which is crucial for maintaining cognitive function. Physical activity also positively impacts sleep by regulating circadian rhythms and reducing sleep disturbances, which are common in MCI patients. Better sleep quality is associated with improved memory consolidation and cognitive performance. These combined effects help slow the progression of cognitive decline in MCI patients, making physical activity a vital component of their treatment plan.

Impact of Combined Photo-Biomodulation and Aerobic Exercise on Cognitive Function and Quality-of-Life in Elderly Alzheimer Patients with Anemia: A Randomized Clinical Trial.Overview the effect of statin therapy on dementia risk, cognitive changes and its pathologic change: a systematic review and meta-analysis.