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Recruiting NCT05534607

Natives Engaged in Alzheimers Research - 'Ike Kupuna

No phase Interventional Mild Cognitive Impairment Subjective Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ola Mau i ka Hula.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Subjective Cognitive Impairment. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral Ola 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

Primary outcome measures

  • Change in participants' systolic blood pressure at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]
  • Change in participants' Hemoglobin A1c at each time frame from baseline [Time frame: 12 months]
  • Change in participants' total cholesterol at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]
  • Change in participants' body mass index at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]
  • Change in participants' Cognitive Change Index score at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]
  • Change in participants' Number Symbol Coding Test score at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]
  • Change in participants' overall Cognivue score at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]
  • Change in participants' overall Quick Dementia Rating System score at each time frame from baseline [Time frame: 3 months, 8 months, 12 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • Kula No Na Po'e — Honolulu
  • Kokua Kalihi Valley — Honolulu
  • Hui No Ke Ola Pono — Wailuku

Identifiers

NCT: NCT05534607 · 'Ike Kupuna

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗