Natives Engaged in Alzheimers Research - 'Ike Kupuna

Mild Cognitive Impairment Clinical Trial

— NEAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534607
• Other study ID #: 'Ike Kupuna
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: January 2023
• Source: University of Hawaii
• Contact: Janice K Worthington, MPH
• Phone: 8086921023
• Email: ikekupuna[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Subjective Cognitive Impairment

Intervention

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, 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.

Locations

Country	Name	City	State
United States	Kokua Kalihi Valley	Honolulu	Hawaii
United States	Kula No Na Po'e	Honolulu	Hawaii
United States	Hui No Ke Ola Pono	Wailuku	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

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