Mild Cognitive ImpairmentNCT05030948
A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
A study testing Tiempo Juntos Intervention in people with Mild Cognitive Impairment, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Tiempo Juntos Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cannot provide informed consent
- Mobility disability
- Musculoskeletal problem / co-morbidity (prevents moderate PA)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Nursing
Philadelphia, Pennsylvania, 19104
About this study
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].
- Conditions
- Mild Cognitive Impairment
- Being tested
- Tiempo Juntos Intervention
- Keywords
- Older Latinos, Cardiovascular Health, Sleep Quality, Cognitive Function, Community Health Worker, Walking, Physical Activity
- Medical subject headings
- Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiempo Juntos InterventionBehavioural
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. 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.
| Study group | Role | What they receive |
|---|---|---|
| Tiempo Juntos Intervention | Experimental | 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. Receives: Behavioral: Tiempo Juntos Intervention |
| Attention Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Physical Activity Frequency at 3 months
Number of activity sessions
Measured: 12 weeks
Change from Baseline Physical Activity Frequency at 6 months
Number of activity sessions
Measured: 24 weeks
Change from Baseline Physical Activity Frequency at 12 months
Number of activity sessions
Measured: 48 weeks
Change from Baseline Physical Activity Intensity at 3 months
Light, moderate, or vigorous (determined by counts per minute)
Measured: 12 weeks
Change from Baseline Physical Activity Intensity at 6 months
Light, moderate, or vigorous (determined by counts per minute)
Measured: 24 weeks
Change from Baseline Physical Activity Intensity at 12 months
Light, moderate, or vigorous (determined by counts per minute)
Measured: 48 weeks
Change from Baseline Physical Activity Duration at 3 months
Total time spent in activity (hours and minutes)
Measured: 12 weeks
Change from Baseline Physical Activity Duration at 6 months
Total time spent in activity (hours and minutes)
Measured: 24 weeks
Change from Baseline Physical Activity Duration at 12 months
Total time spent in activity (hours and minutes)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start27 Aug 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (129)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Gloria Adriana Perez, University of Pennsylvania
- Investigators
- Gloria A Perez, PhD, CRNP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030948
- Sponsor's protocol ID
- 844561
- Other IDs
- 1R01AG070351-01
- Status last verified
- Apr 2026
- First submitted
- 30 Jul 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Snowden M, Steinman L, Mochan K, Grodstein F, Prohaska TR, Thurman DJ, Brown DR, Laditka JN, Soares J, Zweiback DJ, Little D, Anderson LA. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research. J Am Geriatr Soc. 2011 Apr;59(4):704-16. doi: 10.1111/j.1532-5415.2011.03323.x. Epub 2011 Mar 25.
PubMed 21438861Coelho FG, Gobbi S, Andreatto CA, Corazza DI, Pedroso RV, Santos-Galduroz RF. Physical exercise modulates peripheral levels of brain-derived neurotrophic factor (BDNF): a systematic review of experimental studies in the elderly. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):10-5. doi: 10.1016/j.archger.2012.06.003. Epub 2012 Jun 29.
PubMed 22749404Sink KM, Espeland MA, Castro CM, Church T, Cohen R, Dodson JA, Guralnik J, Hendrie HC, Jennings J, Katula J, Lopez OL, McDermott MM, Pahor M, Reid KF, Rushing J, Verghese J, Rapp S, Williamson JD; LIFE Study Investigators. Effect of a 24-Month Physical Activity Intervention vs Health Education on Cognitive Outcomes in Sedentary Older Adults: The LIFE Randomized Trial. JAMA. 2015 Aug 25;314(8):781-90. doi: 10.1001/jama.2015.9617.
PubMed 26305648Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.
PubMed 24102028Chin AL, Negash S, Hamilton R. Diversity and disparity in dementia: the impact of ethnoracial differences in Alzheimer disease. Alzheimer Dis Assoc Disord. 2011 Jul-Sep;25(3):187-95. doi: 10.1097/WAD.0b013e318211c6c9.
PubMed 21399486Committee PAGA. Physical activity guidelines advisory committee scientific report. Washington, DC: US Department of Health and Human Services. 2018.
Gonzales A, Keller C. Mi familia viene primero (My family comes first): Physical activity issues in older Mexican American women. Southern Online Journal of Nursing Research. 2004;5(4):21.
Melillo KD, Williamson E, Houde SC, Futrell M, Read CY, Campasano M. Perceptions of older Latino adults regarding physical fitness, physical activity, and exercise. J Gerontol Nurs. 2001 Sep;27(9):38-46. doi: 10.3928/0098-9134-20010901-08.
PubMed 11820555Marquez DX, Neighbors CJ, Bustamante EE. Leisure time and occupational physical activity among racial or ethnic minorities. Med Sci Sports Exerc. 2010 Jun;42(6):1086-93. doi: 10.1249/MSS.0b013e3181c5ec05.
PubMed 19997031King AC, Castro C, Wilcox S, Eyler AA, Sallis JF, Brownson RC. Personal and environmental factors associated with physical inactivity among different racial-ethnic groups of U.S. middle-aged and older-aged women. Health Psychol. 2000 Jul;19(4):354-64. doi: 10.1037//0278-6133.19.4.354.
PubMed 10907654Marquez DX, Aguinaga S, Campa J, Pinsker EC, Bustamante EE, Hernandez R. A Qualitative Exploration of Factors Associated With Walking and Physical Activity in Community-Dwelling Older Latino Adults. J Appl Gerontol. 2016 Jun;35(6):664-77. doi: 10.1177/0733464814533819. Epub 2014 May 15.
PubMed 24832017Fox AA, Thompson JL, Butterfield GE, Gylfadottir U, Moynihan S, Spiller G. Effects of diet and exercise on common cardiovascular disease risk factors in moderately obese older women. Am J Clin Nutr. 1996 Feb;63(2):225-33. doi: 10.1093/ajcn/63.2.225.
PubMed 8561064Winkleby MA, Feldman HA, Murray DM. Joint analysis of three U.S. community intervention trials for reduction of cardiovascular disease risk. J Clin Epidemiol. 1997 Jun;50(6):645-58. doi: 10.1016/s0895-4356(97)00020-6.
PubMed 9250263Taylor WC, Baranowski T, Young DR. Physical activity interventions in low-income, ethnic minority, and populations with disability. Am J Prev Med. 1998 Nov;15(4):334-43. doi: 10.1016/s0749-3797(98)00081-6.
PubMed 9838976Piedra LM, Andrade FCD, Hernandez R, Trejo L, Prohaska TR, Sarkisian CA. Let's walk! Age reattribution and physical activity among older Hispanic/Latino adults: results from the inverted exclamation markCaminemos! Randomized trial. BMC Public Health. 2018 Aug 3;18(1):964. doi: 10.1186/s12889-018-5850-6.
PubMed 30075709
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
- ClinicalTrials.gov ID
- NCT05030948
- Acronym / sponsor ID
- 844561
- Conditions
- Mild Cognitive Impairment
- Keywords
- Older Latinos, Cardiovascular Health, Sleep Quality, Cognitive Function, Community Health Worker, Walking, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiempo Juntos Intervention | Experimental | Behavioral: Tiempo Juntos InterventionIf 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. |
| Attention Control | No 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 may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Can provide informed consent
- 55+ years
- Self-identify as Hispanic/Latino
- Spanish as primary language
- Willing to attend intervention / education sessions
Key exclusion criteria (3 listed)
- Cannot provide informed consent
- Mobility disability
- Musculoskeletal problem / co-morbidity (prevents moderate PA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiempo Juntos InterventionIf 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. 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. | Behavioural | Tiempo Juntos Intervention |
Primary outcome
Change from Baseline Physical Activity Frequency at 3 months
Time frame: 12 weeks
Number of activity sessions
Change from Baseline Physical Activity Frequency at 6 months
Time frame: 24 weeks
Number of activity sessions
Change from Baseline Physical Activity Frequency at 12 months
Time frame: 48 weeks
Number of activity sessions
Change from Baseline Physical Activity Intensity at 3 months
Time frame: 12 weeks
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 6 months
Time frame: 24 weeks
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 12 months
Time frame: 48 weeks
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Duration at 3 months
Time frame: 12 weeks
Total time spent in activity (hours and minutes)
Change from Baseline Physical Activity Duration at 6 months
Time frame: 24 weeks
Total time spent in activity (hours and minutes)
Change from Baseline Physical Activity Duration at 12 months
Time frame: 48 weeks
Total time spent in activity (hours and minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 21438861Snowden M, Steinman L, Mochan K, Grodstein F, Prohaska TR, Thurman DJ, Brown DR, Laditka JN, Soares J, Zweiback DJ, Little D, Anderson LA. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research. J Am Geriatr Soc. 2011 Apr;59(4):704-16. doi: 10.1111/j.1532-5415.2011.03323.x. Epub 2011 Mar 25.
- Background: PubMed 22749404Coelho FG, Gobbi S, Andreatto CA, Corazza DI, Pedroso RV, Santos-Galduroz RF. Physical exercise modulates peripheral levels of brain-derived neurotrophic factor (BDNF): a systematic review of experimental studies in the elderly. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):10-5. doi: 10.1016/j.archger.2012.06.003. Epub 2012 Jun 29.
- Background: PubMed 26305648Sink KM, Espeland MA, Castro CM, Church T, Cohen R, Dodson JA, Guralnik J, Hendrie HC, Jennings J, Katula J, Lopez OL, McDermott MM, Pahor M, Reid KF, Rushing J, Verghese J, Rapp S, Williamson JD; LIFE Study Investigators. Effect of a 24-Month Physical Activity Intervention vs Health Education on Cognitive Outcomes in Sedentary Older Adults: The LIFE Randomized Trial. JAMA. 2015 Aug 25;314(8):781-90. doi: 10.1001/jama.2015.9617.
- Background: PubMed 24102028Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.
- Background: PubMed 21399486Chin AL, Negash S, Hamilton R. Diversity and disparity in dementia: the impact of ethnoracial differences in Alzheimer disease. Alzheimer Dis Assoc Disord. 2011 Jul-Sep;25(3):187-95. doi: 10.1097/WAD.0b013e318211c6c9.
- BackgroundCommittee PAGA. Physical activity guidelines advisory committee scientific report. Washington, DC: US Department of Health and Human Services. 2018.
- BackgroundGonzales A, Keller C. Mi familia viene primero (My family comes first): Physical activity issues in older Mexican American women. Southern Online Journal of Nursing Research. 2004;5(4):21.
- Background: PubMed 11820555Melillo KD, Williamson E, Houde SC, Futrell M, Read CY, Campasano M. Perceptions of older Latino adults regarding physical fitness, physical activity, and exercise. J Gerontol Nurs. 2001 Sep;27(9):38-46. doi: 10.3928/0098-9134-20010901-08.
- Background: PubMed 19997031Marquez DX, Neighbors CJ, Bustamante EE. Leisure time and occupational physical activity among racial or ethnic minorities. Med Sci Sports Exerc. 2010 Jun;42(6):1086-93. doi: 10.1249/MSS.0b013e3181c5ec05.
- Background: PubMed 10907654King AC, Castro C, Wilcox S, Eyler AA, Sallis JF, Brownson RC. Personal and environmental factors associated with physical inactivity among different racial-ethnic groups of U.S. middle-aged and older-aged women. Health Psychol. 2000 Jul;19(4):354-64. doi: 10.1037//0278-6133.19.4.354.
- Background: PubMed 24832017Marquez DX, Aguinaga S, Campa J, Pinsker EC, Bustamante EE, Hernandez R. A Qualitative Exploration of Factors Associated With Walking and Physical Activity in Community-Dwelling Older Latino Adults. J Appl Gerontol. 2016 Jun;35(6):664-77. doi: 10.1177/0733464814533819. Epub 2014 May 15.
- Background: PubMed 8561064Fox AA, Thompson JL, Butterfield GE, Gylfadottir U, Moynihan S, Spiller G. Effects of diet and exercise on common cardiovascular disease risk factors in moderately obese older women. Am J Clin Nutr. 1996 Feb;63(2):225-33. doi: 10.1093/ajcn/63.2.225.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria A Perez, PhD, CRNP principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiempo Juntos Intervention in people with Mild Cognitive Impairment, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Physical Activity Frequency at 3 months (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05030948, which also lists 129 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.