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AgingCEREBRONCT05588778

Cognitive Enhancement and Risk-reduction Through Exercise for Brain-Related Outcomes

A study testing BAILAMOS™ @home/en casa and ¡En Forma y Fuerte! @home/en casa in people with Aging, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

As the population ages, it is also growing more diverse. Twelve percent of older Latinos are currently diagnosed with Alzheimer's disease (AD), and it is estimated that the number of Latinos with AD will increase by 832% by 2060. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
BAILAMOS™ @home/en casa and ¡En Forma y Fuerte! @home/en casa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 1 Nov 2024
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age > 60 years old;
  • self-identification as Latino/Hispanic;
  • ability to speak Spanish;
  • participation in <1 day/week of aerobic exercise;
  • mild cognitive impairment indicated by scores on the Montreal Cognitive Assessment (MoCA) of > 16 and < 25 or subjective memory complaints determined by a response of "Very often," "Often," or "Sometimes" (not "Rarely" or "Never") to the following question of the Rush Alzheimer's Disease Center: About how often do you have trouble remembering things?;
  • danced < 2 times/month over the past 12 months;
  • willingness to be randomly assigned to either study group;
  • no plans to leave the country for more than two consecutive weeks over the next 6 months.

Who cannot join

  • needing a caregiver for daily functioning, self-reported presence of uncontrolled cardiovascular disease or uncontrolled diabetes mellitus, pacemaker in situ, stroke, severe chronic obstructive pulmonary disease (COPD), and recent healing or unhealed fracture(s).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Illinois at Chicago

    Chicago, Illinois, 60608

Other trials in United States

About this study

Official title: CEREBRO - Cognitive Enhancement and Risk-reduction Through Exercise for Brain-Related Outcomes

As the population ages, it is also growing more diverse. Twelve percent of older Latinos are currently diagnosed with Alzheimer's disease (AD), and it is estimated that the number of Latinos with AD will increase by 832% by 2060. Pharmacological treatments available for cognitive decline/ADRD have shown limited effectiveness in reducing cognitive and functional decline. Evidence suggests that protective factors for AD include regular physical activity (PA). Unfortunately, older Latinos are 46% less likely to engage in leisure time PA than older non-Latino whites. The investigators propose that indoor PA programs can overcome the biggest barriers to participation. Marquez and colleagues created a Spanish-language, Latin dance program (BAILAMOS™ - Balance and Activity In Latinos, Addressing Mobility in Older Adults). Smaller studies of BAILAMOS™ have found greater improvement in global cognition in the dance group compared to a health education group, and increases in brain functional connectivity. UIC faculty have also designed and tested Fit \& Strong!, a PA program for older adults with arthritis, that is recognized by the National Council on Aging as an Evidence-based program and have established the feasibility of ¡En Forma y Fuerte!, an adaptation of Fit \& Strong! for Latinos with arthritis. A small trial found significant improvements in lower-extremity strength, perceived physical function, and pain from baseline to 8 weeks (p < .05) that were maintained at 6 months. No major program adaptations (other than language) were observed or reported; however, the instructors provided several suggestions for program improvements, including adjusting the literacy level and length of the program. The current pandemic allows the investigators to adapt both of these evidence informed programs, the BAILAMOS™ dance program and ¡En Forma y Fuerte!, for remote delivery among older Latinos (i.e., BAILAMOS™ @home/en casa and ¡En Forma y Fuerte! @home/en casa). The overall purpose is to implement promising, evidence-informed interventions and solutions to reduce risk for ADRD and improve quality of life for persons with symptoms of cognitive decline.

Read the detailed description

By 2065, the Latino population in the U.S. is expected to grow to 107 million. Currently, 12% of older Latinos are diagnosed with Alzheimer's disease (AD); it is estimated their number will increase by 832% by 2060. Latinos have a greater risk of developing chronic conditions involving modifiable lifestyle factors, and evidence suggests that cardiovascular disease risk factors may also be a risk for AD and related dementias (ADRD), thus placing Latinos at even greater risk for ADRD.

Pharmacological treatments available for ADRD have shown limited effectiveness in reducing cognitive and functional decline, thus, the establishment of interventions that can reduce ADRD risk is critical. While there is no cure for AD, evidence suggests that protective factors for AD include regular physical activity (PA). Unfortunately, older Latinos are 46% less likely to engage in leisure time PA than older non-Latino whites.

Walking and dancing are the two most commonly reported forms of PA among older Latinos. However, urban older Latinos cite unsafe neighborhoods and extreme weather conditions as significant barriers to walking. Older Latinos value functional independence, and relate physical fitness to feeling healthy and being able to perform normal activities with ease, but have rarely had traditional exercise programs adapted to their needs. The investigators propose that indoor PA programs can overcome the biggest barriers to participation. Latin dance is a particularly promising PA modality that is a culturally acceptable type of PA for middle- aged and older Latinos. Randomized controlled trials (RCTs) have examined changes in cognitive performance among several types of dance styles and have found improvements in global cognition, executive function, episodic and working memory, and attention. However, PA interventions have not implemented dance programs specifically for Latinos, a historically excluded population at high risk of cognitive impairment. Given the need to address health inequities in Latinos, Marquez and colleagues created a Spanish-language, Latin dance program (BAILAMOS™ - Balance and Activity In Latinos, Addressing Mobility in Older Adults). Smaller studies of BAILAMOS™ have found greater improvement in global cognition in the dance group compared to a health education group, and increases in brain functional connectivity. Moreover, the investigators established the feasibility and impact on PA in older Latinos who already had MCI (n=20).

UIC faculty have also designed and tested Fit \& Strong!, a PA program for older adults with arthritis, that is recognized by the National Council on Aging as an Evidence-based program and have established the feasibility of ¡En Forma y Fuerte!, an adaptation of Fit \& Strong! for Latinos with arthritis. A small trial found significant improvements in lower-extremity strength, perceived physical function, and pain from baseline to 8 weeks (p < .05) that were maintained at 6 months. No major program adaptations (other than language) were observed or reported; however, the instructors provided several suggestions for program improvements, including adjusting the literacy level and length of the program.

The current pandemic allows the investigators to adapt both of these evidence informed programs, the BAILAMOS™ dance program and ¡En Forma y Fuerte!, for remote delivery among older Latinos (i.e., BAILAMOS™ @home/en casa and ¡En Forma y Fuerte! @home/en casa). The overall purpose is to implement promising, evidence-informed interventions and solutions to reduce risk for ADRD and improve quality of life for persons with symptoms of cognitive decline. Our previous engagement as a collaborating center of the CDC Healthy Aging Research Network (HAN) and the CDC Healthy Brain Research Network (HBRN), plus our evidence-the focus of our NIA Roybal Center on PA and cognition, make the UIC PRC DRRRN well suited to contribute expertise to the network.

Conditions
Aging
Being tested
BAILAMOS™ @home/en casa, ¡En Forma y Fuerte! @home/en casa
Keywords
Latino, older adults, cognition, physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAILAMOS™ @home/en casaBehavioural

    Also called BAILAMOS™

    The BAILAMOS™ dance program and dance manual. BAILAMOS™ originally encompassed four dance styles: Merengue, Cha Cha Cha, Bachata, and Salsa. These four styles of Latin dance are generally considered the most popular in terms of recognition and preference. We have added two styles to appeal to the largely Mexican-origin Latinos in Chicago (i.e., Cumbia and Samba). The dances were jointly choreographed by the PI and Mr. Mendez, a professional dance instructor and owner of The Dance Academy of Salsa and http://www.salsachicago.com/. The PI and dance instructor co-developed the extensive manual is used by program instructors and includes background information on the authors, an introduction describing the goals of the program, and descriptions of the various styles of dance. The manual also has photos and descriptions of each dance broken down into its component parts.

  • ¡En Forma y Fuerte! @home/en casaBehavioural

    Also called Fit & Strong!

    The ¡En Forma y Fuerte! Program. ¡En Forma y Fuerte! is designed to be delivered in Spanish by bilingual, bicultural, qualified exercise instructors. Instructors are required to have an exercise instructor/specialist certification through a national organization such as the American College of Sports Medicine, American Council on Exercise, or Aerobics and Fitness Association of America, or to have an undergraduate degree in an exercise science related field. The 8 hour training uses both didactic and hands-on role modeling for delivering both the exercise and health education components of the program. Instructors in the online version will also participate in a 60 minute training designed for this new version of the program. We have previously developed an asynchronous, online instructor training for the customary program and will translate it to Spanish for this proposal.

Study groups in NCT05588778
Study groupRoleWhat they receive
BAILAMOS™ @home/en casaExperimentalThe BAILAMOS™ @home/en casa dance program is provided twice weekly for 24 weeks. Each month a new dance style is introduced by a professional dance instructor.
Receives: Behavioral: ¡En Forma y Fuerte! @home/en casa
¡En Forma y Fuerte! @home/en casaExperimental¡En Forma y Fuerte! @home/en casa is an exercise and health education program designed to improve arthritis-related outcomes. The classes will meet two times per week for 90 min each for 12 weeks. Each class session consists of 60 min of exercise (flexibility, aerobics and strength training) and 30 minutes of health education using group problem solving based on SCT.
Receives: Behavioral: ¡En Forma y Fuerte! @home/en casa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment and retention

    "Feasible" will entail a total of 100 participants enrolled and ≥75% retained (operationalized as take part in post-intervention testing) at year 2 end.

    Measured: Pre-intervention through study completion, an average of 1 year

  2. Feasibility - Intervention adherence

    "Feasible" will entail ≥75% participants with ≥80% of intervention sessions completed across waves.

    Measured: Pre-intervention through study completion, an average of 1 year

Secondary outcomes (5)
  1. Self-Report Physical activity

    The CHAMPS Physical Activity Questionnaire for Older Adults is a change-sensitive PA scale that assesses weekly frequency and duration of lifestyle PA (leisure time, household, occupational, and transportation PA) typically undertaken by older adults.

    Measured: Pre-intervention through study completion, an average of 1 year

  2. Device-assessed Physical activity

    ActiGraph Model GT3X-Plus accelerometers (The Actigraph, Pensacola, FL) are small and lightweight triaxial accelerometers that measure accelerations in three planes. Time spent in light, moderate or vigorous intensity PA (Miller et al. cutpoints for older adults) will be assessed. Data will be included in analysis if the accelerometer displays at least 10 hours of data (> 0 count values for each hour) in a 24-hour period on at least 4 days.

    Measured: Pre-intervention through study completion, an average of 1 year

  3. Cognition

    Neuropsychological measures of executive function, attention, episodic memory, processing speed and working memory from the NIH Toolbox for the Assessment of Neurological Behavior and Function Cognition Battery (NIHTB-CB) will be used.

    Measured: Pre-intervention through study completion, an average of 1 year

  4. Health Related Quality of life

    The SF-12 scale consists of 12 items and eight scales: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and perceived mental health (MH). The composite physical (PCS) and mental health (MCS) scores are computed using the scores of the 12 items, ranging from 0 to 100, where zero reflects the lowest health level and 100 the highest level.

    Measured: Pre-intervention through study completion, an average of 1 year

  5. Social connectedness

    Social connectedness will be assessed with Cohen's Social Network Index. It is a 12-item questionnaire that assesses participation in 12 types of social relationships including spouse, parents, friends, family members, etc.

    Measured: Pre-intervention through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start1 Aug 2023
  3. Primary completion14 Oct 2024
  4. Study completion1 Nov 2024

Resources

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
Model description
Conduct a 6-month RCT comparing BAILAMOS™ @home/en casa and ¡En Forma y Fuerte! @home/en casa among 100 older Latino adults with symptoms of cognitive decline.
Masking
Single blind
Who is masked
Participant
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588778
Sponsor's protocol ID
3U48DP006392-04S6
Acronym
CEREBRO
Status last verified
Nov 2024
First submitted
13 Oct 2022
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ocampo-Mota J, Padilla D, Karlinsey Skidmore B, Cardiel E, Khanna S, Pinto M, Marquez DX. Ojo 2-barriers and recommendations for the recruitment, retention, and implementation of remote physical activity interventions for older Latinos. Transl Behav Med. 2026 Jan 7;16(1):ibag066. doi: 10.1093/tbm/ibag066.

    PubMed 42801273
  • Ocampo-Mota J, Soto Y, Negrete MA, Cardiel E, Skidmore BK, Pinto M, Marquez DX. Feasibility and acceptability of two remote physical activity programs for older Latino adults: the C.E.R.E.B.R.O. study, a pilot randomized trial. Front Med (Lausanne). 2026 Aug 28;13:1862017. doi: 10.3389/fmed.2026.1862017. eCollection 2026.

    PubMed 42729162

Questions about this trial

What is this clinical trial studying?

A study testing BAILAMOS™ @home/en casa and ¡En Forma y Fuerte! @home/en casa in people with Aging, run by University of Illinois Chicago 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 1 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 8 Nov 2024. 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?

Feasibility of recruitment and retention (time frame: Pre-intervention through study completion, an average of 1 year). The study lists 2 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 NCT05588778, which also lists 2 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 8 Nov 2024.

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