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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Study Summary
This trial will test an intervention designed to promote moderate-intensity physical activity, with the goal of improving cardiovascular health, sleep and cognitive function.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 55 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,124 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,004,076 Total Patients Enrolled
Gloria A Perez, PhD, CRNPPrincipal InvestigatorUniversity of Pennsylvania
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 55 years old or older.I have difficulty moving around on my own.I have a condition that stops me from doing moderate exercise.I am willing to attend all required sessions.
Research Study Groups:
This trial has the following groups:- Group 1: Tiempo Juntos Intervention
- Group 2: Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for individuals to participate in this clinical trial?
"Clinicaltrials.gov confirms that this medical trial, which originally launched on August 27th 2021, is presently recruiting patients. The study was last revised on November 1st 2022."
Answered by AI
How many individuals have agreed to participate in this medical experiment?
"Affirmative. Clinicaltrials.gov discloses that this medical study was initially posted on August 27th 2021, and is currently recruiting participants. In total, 216 individuals must be enlisted from a single research centre."
Answered by AI
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