Clinical trial NCT05534607: Natives Engaged in Alzheimers Research - 'Ike Kupuna
Official title: Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Subjective Cognitive Impairment
Keywords: MCI
Alzheimer's disease
Alzheimer's disease and related dementias
Vascular dementia
ADRD
SCI
Native Hawaiian and Pacific Islander
NHPI
Hula
cultural based intervention
behavioral intervention
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study uses a wait list control design, where the wait-list control group is offered the intervention at the completion of the intervention group's 12-month intervention and assessment period.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in participants' systolic blood pressure at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
measure: Change in participants' Hemoglobin A1c at each time frame from baseline
timeFrame: 12 months
measure: Change in participants' total cholesterol at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
measure: Change in participants' body mass index at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
measure: Change in participants' Cognitive Change Index score at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
measure: Change in participants' Number Symbol Coding Test score at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
measure: Change in participants' overall Cognivue score at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
measure: Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
timeFrame: 3 months, 8 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kula No Na Po'e
state: Hawaii
city: Honolulu
country: United States
facility: Kokua Kalihi Valley
state: Hawaii
city: Wailuku
country: United States
facility: Hui No Ke Ola Pono
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Joseph K Kaholokula, PhD
role: PRINCIPAL_INVESTIGATOR
References: