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.
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
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