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Natives Engaged in Alzheimers Research - 'Ike Kupuna

ConditionsMild Cognitive ImpairmentSubjective Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorUniversity of Hawaii

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

self-reported Native Hawaiian or other Pacific Islander ancestry;

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);

has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);

have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2);

Disqualifiers

currently pregnant;

already actively practicing Hula at least once per week; or

clinical diagnosis of ADRD (mild to severe); or

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ola Mau i ka Hula

    Behavioral

    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.

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Wait-list control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in participants' systolic blood pressure at each time frame from baseline

Vascular risk factor assessed using Omron©HEM-907XL

Time frame
3 months, 8 months, 12 months
2

Change in participants' Hemoglobin A1c at each time frame from baseline

Vascular risk factor assessed using Alere Cholestech LDX® System

Time frame
12 months
3

Change in participants' total cholesterol at each time frame from baseline

Vascular risk factor assessed using Alere Cholestech LDX® System

Time frame
3 months, 8 months, 12 months
4

Change in participants' body mass index at each time frame from baseline

Vascular risk factor assessed using Tanita BWB800AS scale

Time frame
3 months, 8 months, 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hawaii

Lead sponsor

Source ClinicalTrials.gov
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