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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 weeks
Treatment ~ Varies
Follow Up ~3 months, 8 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 8 months, 12 months for reporting.

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 more

NEAR 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.

Find a Location

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

Media Library

Ola Mau i ka Hula (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05534607 — N/A
Mild Cognitive Impairment Research Study Groups: Wait-list control group, Intervention group
Ola Mau i ka Hula (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534607 — N/A
Mild Cognitive Impairment Clinical Trial 2023: Ola Mau i ka Hula Highlights & Side Effects. Trial Name: NCT05534607 — N/A
~62 spots leftby Apr 2025