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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| BAILAMOS™ @home/en casa | Experimental | The 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 casa | Experimental | ¡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.
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
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)
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
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
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
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
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.
- First posted20 Oct 2022
- Study start1 Aug 2023
- Primary completion14 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Xavier Marquez, University of Illinois Chicago
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 42801273Ocampo-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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEREBRO - Cognitive Enhancement and Risk-reduction Through Exercise for Brain-Related Outcomes
- ClinicalTrials.gov ID
- NCT05588778
- Acronym / sponsor ID
- CEREBRO / 3U48DP006392-04S6
- Conditions
- Aging
- Keywords
- Latino, older adults, cognition, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 20 Oct 2022 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BAILAMOS™ @home/en casa | Experimental | Behavioral: ¡En Forma y Fuerte! @home/en casaThe 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. |
| ¡En Forma y Fuerte! @home/en casa | Experimental | Behavioral: ¡En Forma y Fuerte! @home/en casa¡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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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?;
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| BAILAMOS™ @home/en casaAlso: 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. | Behavioural | – |
| ¡En Forma y Fuerte! @home/en casaAlso: 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. | Behavioural | BAILAMOS™ @home/en casa, ¡En Forma y Fuerte! @home/en casa |
Primary outcome
Feasibility of recruitment and retention
Time frame: Pre-intervention through study completion, an average of 1 year
"Feasible" will entail a total of 100 participants enrolled and ≥75% retained (operationalized as take part in post-intervention testing) at year 2 end.
Feasibility - Intervention adherence
Time frame: Pre-intervention through study completion, an average of 1 year
"Feasible" will entail ≥75% participants with ≥80% of intervention sessions completed across waves.
5 secondary outcomes
Self-Report Physical activity
Time frame: Pre-intervention through study completion, an average of 1 year
Device-assessed Physical activity
Time frame: Pre-intervention through study completion, an average of 1 year
Cognition
Time frame: Pre-intervention through study completion, an average of 1 year
Health Related Quality of life
Time frame: Pre-intervention through study completion, an average of 1 year
Social connectedness
Time frame: Pre-intervention through study completion, an average of 1 year
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 8 Nov 2024.
- Derived from this study: PubMed 42801273Ocampo-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.
- Derived from this study: PubMed 42729162Ocampo-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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.