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

NCT05588778 | Completed

• 1 other identifier: 3U48DP006392-04S6
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Latino; older adults; cognition; physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (5)

• Self-Report Physical activity

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

• Device-assessed Physical activity

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

• Cognition

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

• Health Related Quality of life

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

• Social connectedness

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

Study Arms (2)

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.

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.

Behavioral: ¡En Forma y Fuerte! @home/en casa

Interventions

BAILAMOS™ @home/en casa BEHAVIORAL

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.

Also known as: BAILAMOS™

¡En Forma y Fuerte! @home/en casa 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.

Also known as: Fit & Strong!

BAILAMOS™ @home/en casa; ¡En Forma y Fuerte! @home/en casa

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be explicitly told which condition they are randomized to, but are likely to know. All data collectors will be blinded to participants' study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 20, 2022
• Study Start: August 1, 2023
• Primary Completion: October 14, 2024
• Study Completion: November 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)