Natives Engaged in Alzheimers Research - 'Ike Kupuna

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment; Subjective Cognitive Impairment
• Interventions: Behavioral: Ola Mau i ka Hula

• Registration Number: NCT05534607
• Lead Sponsor: University of Hawaii

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.

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-09
• Study Start: 2022-09-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-06-15
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Ola Mau i ka Hula	The intervention group will immediately receive the Ola Mau i ka Hula intervention after randomization for 12 months. The intervention program is 8 months with a 4 month self-monitoring period.

Primary Outcome Measures

Name	Time	Method
Change in participants' Hemoglobin A1c at each time frame from baseline	12 months	Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' body mass index at each time frame from baseline	3 months, 8 months, 12 months	Vascular risk factor assessed using Tanita BWB800AS scale
Change in participants' overall Cognivue score at each time frame from baseline	3 months, 8 months, 12 months	Cognitive function assessed using Cognivue device
Change in participants' total cholesterol at each time frame from baseline	3 months, 8 months, 12 months	Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' Cognitive Change Index score at each time frame from baseline	3 months, 8 months, 12 months	Cognitive function assessed using Cognitive Change Index assessment
Change in participants' Number Symbol Coding Test score at each time frame from baseline	3 months, 8 months, 12 months	Cognitive function assessed using Number Symbol Coding Test
Change in participants' systolic blood pressure at each time frame from baseline	3 months, 8 months, 12 months	Vascular risk factor assessed using Omron©HEM-907XL
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline	3 months, 8 months, 12 months	Cognitive function assessed using Quick Dementia Rating System assessment

Trial Locations

Locations (3)

Hui No Ke Ola Pono; 🇺🇸 Wailuku, Hawaii, United States

Kula No Na Po'e; 🇺🇸 Honolulu, Hawaii, United States

Kokua Kalihi Valley; 🇺🇸 Honolulu, Hawaii, United States