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Behavioral Intervention
Hula for Cognitive Impairment (NEAR Trial)
N/A
Recruiting
Led By Joseph K Kaholokula, PhD
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 8 months, 12 months
Awards & highlights
NEAR Trial Summary
This trial will test whether a hula-based intervention can improve vascular risk factors, cognitive function, and complaints over 12 months in people with or at risk for ADRD.
Who is the study for?
This trial is for Native Hawaiians or other Pacific Islanders aged 50-75 with cognitive complaints, who are physically able to do moderate exercise like Hula. They must have hypertension, diabetes, high cholesterol, or obesity and a doctor's approval to participate. It's not for those already doing Hula weekly, pregnant women, people with Alzheimer's disease or severe depression.Check my eligibility
What is being tested?
The study tests if a hula-based physical activity can improve vascular risk factors and cognitive function over a year in participants with subjective cognitive impairment (SCI) or mild cognitive impairment (MCI).See study design
What are the potential side effects?
Since the intervention involves physical activity through Hula dancing, potential side effects may include muscle soreness or strain. However, these activities are generally considered safe when performed within one's physical limits.
NEAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months, 8 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 8 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in participants' Cognitive Change Index score at each time frame from baseline
Change in participants' Hemoglobin A1c at each time frame from baseline
Change in participants' Number Symbol Coding Test score at each time frame from baseline
+5 moreNEAR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
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.
Group II: Wait-list control groupActive Control1 Intervention
After baseline data collection, participants randomized to the wait-list control arm will not receive the Ola Mau i ka Hula Program while their counterparts who were randomized to the intervention arm are undergoing the intervention program. Thus, they will not be offered the intervention until after the intervention arm is completed and their 12-month follow-up data collection is completed. They will only receive the educational component of the intervention from us during this 12-month period but they will be instructed to continue with their routine medical care as usual.
Wait-list control group will be offered the opportunity to receive intervention at the conclusion of 12 month assessment period, regardless of whether they were retained for the full 12 months of data collection.
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Who is running the clinical trial?
University of HawaiiLead Sponsor
115 Previous Clinical Trials
54,497 Total Patients Enrolled
Joseph K Kaholokula, PhDPrincipal InvestigatorUniversity of Hawaii
5 Previous Clinical Trials
1,092 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You identify yourself as being of Native Hawaiian or Pacific Islander descent based on your own report.I have been diagnosed with moderate or severe depression.I am between 50 and 75 years old.I have been diagnosed with Alzheimer's or a related dementia.I have been diagnosed with high blood pressure, diabetes, high cholesterol, or obesity.I have been diagnosed with high blood pressure, diabetes, high cholesterol, or obesity.You have memory or thinking problems that may affect your ability to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Wait-list control group
- Group 2: Intervention group
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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