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NCT Number: NCT05534607

Natives Engaged in Alzheimers Research - 'Ike Kupuna

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Subjective Cognitive Impairment Tauopathies Vascular Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kokua Kalihi Valley, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • physically able and willing to engage in moderate physical activity necessary for Hula; and
  • physician's approval to participate in moderate physical activity

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: Ola Mau

Primary outcomes

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

    Time frame: 3 months, 8 months, 12 months

    Vascular risk factor assessed using Omron©HEM-907XL

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

    Time frame: 12 months

    Vascular risk factor assessed using Alere Cholestech LDX® System

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

    Time frame: 3 months, 8 months, 12 months

    Vascular risk factor assessed using Alere Cholestech LDX® System

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

    Time frame: 3 months, 8 months, 12 months

    Vascular risk factor assessed using Tanita BWB800AS scale

  5. Change in participants' Cognitive Change Index score at each time frame from baseline

    Time frame: 3 months, 8 months, 12 months

    Cognitive function assessed using Cognitive Change Index assessment

  6. Change in participants' Number Symbol Coding Test score at each time frame from baseline

    Time frame: 3 months, 8 months, 12 months

    Cognitive function assessed using Number Symbol Coding Test

  7. Change in participants' overall Cognivue score at each time frame from baseline

    Time frame: 3 months, 8 months, 12 months

    Cognitive function assessed using Cognivue device

  8. Change in participants' overall Quick Dementia Rating System score at each time frame from baseline

    Time frame: 3 months, 8 months, 12 months

    Cognitive function assessed using Quick Dementia Rating System assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Janice K Worthington, MPH

CONTACT

[email protected]

8086921023

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Official study title

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

Acronym: NEAR

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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