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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01988233
Other study ID # 2012-0851
Secondary ID 1R01NR013151
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date June 2017

Study information

Verified date July 2022
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators propose a randomized controlled trial (RCT) to test the efficacy of the revised 4-month BAILAMOS© program for improving lifestyle PA and health outcomes (physical and cognitive function, self-reported functional limitations, disability) in sedentary older Latinos at risk for disability relative to an attention control group.


Description:

Older Latinos comprised 7% of the older adult population in 2002, but are expected to constitute 20% by 2050. Physical activity (PA) can influence potential declines in the health outcomes of physical and cognitive function that lead to functional limitations (self-reported restrictions in performance) and disability (functional limitations placed in a social context). Unfortunately, Latinos aged 65-74 are 46% less likely to engage in leisure time PA than older non-Latino whites and little is known about PA maintenance among ethnic minorities compared to non-Latino whites. In part as a result of low levels of PA, the physical and cognitive function of older Latinos is poor relative to older non-Latino whites. Participation in PA has substantial potential to help older Latinos maintain both physical and cognitive function as they age. 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. Dance is a widely popular form of PA among Latinos of all ages, and holds considerable promise as a culturally appropriate form of PA that challenges individuals both physically and cognitively. To date, PA programs designed for older Latinos are lacking. BAILAMOS© is an innovative dance program that has been developed by Dr. Marquez (PI) based on focus group input from older community-dwelling Latinos and in collaboration with an accomplished Latin dance instructor. Investigators propose a randomized controlled trial (RCT) to test the efficacy of the revised 4-month BAILAMOS© program for improving lifestyle PA and health outcomes (physical and cognitive function, self-reported functional limitations, disability) in sedentary older Latinos at risk for disability relative to an attention control group. Investigators will also test whether lifestyle PA and health outcomes can be maintained over an additional 4-months through BAILAMOS© maintenance activities, which include using indigenous dance leaders. This study will use an RCT (N=166 Treatment, 166 Control) with a health education control group that will allow investigators to examine the adoption of PA and its impact on health outcomes (first 4 months), and the short-term maintenance of PA and its impact on health outcomes (8 months) among older Latinos.


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - age > 55 years old - self-identification as Latino/Hispanic - ability to speak Spanish - participation in <3 day/week of aerobic exercise - at risk for disability - adequate cognitive status as assessed by the Mini Mental State Examination - danced < 2 times/month over the past 12 months - willingness to be randomly assigned to treatment or control group - no plans to leave the country for more than two consecutive weeks over the next year Exclusion Criteria: - uncontrolled cardiovascular disease - uncontrolled diabetes mellitus - pacemaker in situ - severe chronic obstructive pulmonary disease (COPD) - recent healing or unhealed fracture(s) - use of an assistance device to walk (cane, walker, or wheelchair)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BAILAMOS© Dance Program

Health Education Control Group


Locations

Country Name City State
United States West Suburban Senior Services, Inc Bellwood Illinois
United States Catholic Charities of the Archdioceses of Chicago St Mary of Celle Strengthening Center Berwyn Illinois
United States Dance Academy of Salsa Chicago Illinois
United States Holy Cross/Immaculate Heart of Mary Parish Chicago Illinois
United States Kelvyn Park Senior Center Chicago Illinois
United States Northwest (Copernicus) Regional Senior Center Chicago Illinois
United States Pilsen Senior Center Chicago Illinois
United States Southwest Senior Center Chicago Illinois
United States St. Agnes of Bohemia Parish Chicago Illinois
United States Villa Guadalupe Senior Services, Inc. Chicago Illinois
United States West Town Senior Center Chicago Illinois
United States Our Lady of Mount Carmel Melrose Park Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minutes Per Week of Moderate to Vigorous Physical Activity CHAMPS PA Questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. Change from baseline to post-intervention 4 months
Secondary Physical Function Performance as Assessed by Time of 400 Meter Walk 400 Meter walk Change from baseline to post-intervention 4 months
Secondary Cognitive Function Working Memory: The score is the number of correctly retrieved strings in each part of the Digit Span Test plus the number of correctly reordered strings from the Digit Ordering. Higher scores indicated better outcomes. Higher change indicate better outcomes. Change from baseline to post-intervention 4 months
Secondary Self-Reported Functional Limitations Function Subscale of Late Life Function & Disability Instrument. Higher scores reflect more limitation in performing tasks. Range on questionnaire is 15-75. Change is reported here. Change from baseline to post-intervention 4 months
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