Clinical trial NCT03269149: Tango for Alzheimer's Disease Patients' Caregivers
Official title: Effects of Adapted Tango on African-American Women Caregivers of Alzheimer's Disease Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
African-American Women
Caregivers
Tango
Dance-based intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2017-08-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease (AD).

Detailed description: The importance of informal family caregiving in Alzheimer's disease (AD) is well-established. African-American caregivers are most often middle aged adult children of AD patients (vs. spouses), women, and are at higher risk for chronic health problems. AD lifestyle interventions offer an alternative to medication, and are generally affordable, accessible, and adaptable to the lives of caregivers. To date, most non-pharmaceutical interventions have focused on exercise and nutrition, both of which have proven to be highly successful in conferring AD related benefits and decreasing AD risk.

The goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in African American (AA) female family caregivers, at high risk for Alzheimer's disease.

Eligibility criteria: Inclusion Criteria:

* Women family caregivers from the Emory ADRC and Dr. Wharton's studies of Alzheimer's disease (AD) caregivers
* Parental diagnosis 'probable AD'
* African-American
* 45-65 years of age

Primary outcomes:
measure: Change in interleukin-7
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in interleukin-8
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in interleukin-9
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in Interleukin-10
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in interferon induced protein 10
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in macrophage derived chemokine
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in monocyte chemoattractant protein 1
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in transforming growth factor alpha
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in tumor necrosis factor alpha
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in C-reactive protein
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
measure: Change in serum amyloid protein
timeFrame: Before and after the intervention / control at least 20 times during 12 weeks
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in the Tower of London test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in the Stroop interference test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Trails B test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Digit Span test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Buschke Selective Reminding Test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Reverse Corsi Blocks test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Brooks spatial memory test
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in the Body position spatial task (BPST)
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Fullerton Advanced Balance Scale
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in 30-second chair stand
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in gait speed
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Positive Aspects of Caregiving (PAC) Scale
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in Pearlin Caregiver Stress Scale
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in the Zarit Burden Interview
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
measure: Change in DEMQOL: Dementia Quality of Life measure (Carer v4)
timeFrame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta VA Medical Center, Emory University, Executive Park, Wesley Woods
state: Georgia
Study officials:
affiliation: School Of Medicine, Emory University
name: Madeleine Hackney
role: PRINCIPAL_INVESTIGATOR
References: