NCT05534607 · University of Hawaii
Natives Engaged in Alzheimers Research - 'Ike Kupuna
(NEAR)
What this study is about
This study will conduct a group randomly assigned 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.
View original scientific description
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.
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, 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.
Primary outcome measures
Change in participants' systolic blood pressure at each time frame from baseline
Time frame: 3 months, 8 months, 12 months
Vascular risk factor assessed using Omron©HEM-907XL
Change in participants' Hemoglobin A1c at each time frame from baseline
Time frame: 12 months
Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' total cholesterol at each time frame from baseline
Time frame: 3 months, 8 months, 12 months
Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' body mass index at each time frame from baseline
Time frame: 3 months, 8 months, 12 months
Vascular risk factor assessed using Tanita BWB800AS scale
Change in participants' Cognitive Change Index score at each time frame from baseline
Time frame: 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
Time frame: 3 months, 8 months, 12 months
Cognitive function assessed using Number Symbol Coding Test
Change in participants' overall Cognivue score at each time frame from baseline
Time frame: 3 months, 8 months, 12 months
Cognitive function assessed using Cognivue device
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
Time frame: 3 months, 8 months, 12 months
Cognitive function assessed using Quick Dementia Rating System assessment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Honolulu, Hawaii
- Wailuku, Hawaii
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2024 · Source of record for eligibility and locations