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Natives Engaged in Alzheimers Research - 'Ike Kupuna

Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05534607
Acronym
NEAR
Enrollment
192
Registered
2022-09-09
Start date
2022-09-15
Completion date
2027-04-30
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Subjective Cognitive Impairment

Keywords

MCI, Alzheimer's disease, Alzheimer's disease and related dementias, Vascular dementia, ADRD, SCI, Native Hawaiian and Pacific Islander, NHPI, Hula, cultural based intervention, behavioral intervention

Brief summary

This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.

Detailed description

This study will conduct a pragmatic group-randomized trial (GRT) with NHPIs aged 50-75 years with at least 1 of 4 modifiable vascular risk factors for ADRD (hypertension, hyperglycemia, obesity, or dyslipidemia) and either SCI or MCI using a wait-list control design to test the effects of the hula-based intervention. The primary outcomes will be vascular risk factors for ADRD and subjective cognitive complaints. Secondary outcomes will include measures of cognitive performance, physical function, and mental health.

Interventions

BEHAVIORALOla Mau i ka Hula

The first 3 months of the hula-based intervention program was designed and standardized as a culturally-based physical activity (PA) that includes 15 minutes of ADRD education and intervention orientation with 12 weeks of hula lessons. These hula lessons consist of two 60-minute classes per week over 12 weeks. Each hula lesson will consist of 8 participants, providing them with the opportunity to engage-in this social support network. For the remaining 5 months of the Ola Mau i ka Hula Program, hula lessons led by the kumu hula will be reduced to once a month for 60 min. In addition, the intervention group will meet with a community-peer educator weekly over this 5-month period. Each meeting will be 90 minutes in length with 60 minutes of hula practice following the same format as previous classes, and 30 minutes will cover the PILI Lifestyle Plan curriculum and cultural-based cognitive exercises, alternating weekly.

Sponsors

University of Hawaii
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The study uses a wait list control design, where the wait-list control group is offered the intervention at the completion of the intervention group's 12-month intervention and assessment period.

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. self-reported Native Hawaiian or other Pacific Islander ancestry; 2. ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age); 3. has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI); 4. have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2); 5. physically able and willing to engage in moderate physical activity necessary for Hula; and 6. physician's approval to participate in moderate physical activity

Exclusion criteria

1. currently pregnant; 2. already actively practicing Hula at least once per week; or 3. clinical diagnosis of ADRD (mild to severe); or 4. current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).

Design outcomes

Primary

MeasureTime frameDescription
Change in participants' systolic blood pressure at each time frame from baseline3 months, 8 months, 12 monthsVascular risk factor assessed using Omron©HEM-907XL
Change in participants' Hemoglobin A1c at each time frame from baseline12 monthsVascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' total cholesterol at each time frame from baseline3 months, 8 months, 12 monthsVascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' body mass index at each time frame from baseline3 months, 8 months, 12 monthsVascular risk factor assessed using Tanita BWB800AS scale
Change in participants' Cognitive Change Index score at each time frame from baseline3 months, 8 months, 12 monthsCognitive function assessed using Cognitive Change Index assessment
Change in participants' Number Symbol Coding Test score at each time frame from baseline3 months, 8 months, 12 monthsCognitive function assessed using Number Symbol Coding Test
Change in participants' overall Cognivue score at each time frame from baseline3 months, 8 months, 12 monthsCognitive function assessed using Cognivue device
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline3 months, 8 months, 12 monthsCognitive function assessed using Quick Dementia Rating System assessment

Countries

United States

Contacts

Primary ContactJanice K Worthington, MPH
ikekupuna@gmail.com8086921023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026