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

NCT ID: NCT05588778

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-11-01

Brief 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. 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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

BAILAMOS™ @home/en casa

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.

Group Type: EXPERIMENTAL

¡En Forma y Fuerte! @home/en casa

Intervention Type: BEHAVIORAL

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.

¡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.

Group Type: EXPERIMENTAL

¡En Forma y Fuerte! @home/en casa

Intervention Type: BEHAVIORAL

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.

Interventions

BAILAMOS™ @home/en casa

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.

Intervention Type: BEHAVIORAL

¡En Forma y Fuerte! @home/en casa

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BAILAMOS™; Fit & Strong!

Eligibility Criteria

Inclusion Criteria

1. age > 60 years old;

2. self-identification as Latino/Hispanic;

3. ability to speak Spanish;

4. participation in <1 day/week of aerobic exercise;

5. 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?;

6. danced < 2 times/month over the past 12 months;

7. willingness to be randomly assigned to either study group;

8. no plans to leave the country for more than two consecutive weeks over the next 6 months.

Exclusion Criteria

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

David Xavier Marquez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

3U48DP006392-04S6

Identifier Type: NIH

Identifier Source: org_study_id

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