Natives Engaged in Alzheimers Research - 'Ike Kupuna

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• Kula No Na Po'e — Honolulu
• Kokua Kalihi Valley — Honolulu
• Hui No Ke Ola Pono — Wailuku

Идентификаторы

NCT: NCT05534607 · 'Ike Kupuna

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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