Mild Cognitive ImpairmentNEARNCT05534607
Natives Engaged in Alzheimers Research - 'Ike Kupuna
A study testing Ola Mau i ka Hula in people with Mild Cognitive Impairment and Subjective Cognitive Impairment, run by University of Hawaii at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Subjective Cognitive Impairment
- What is being tested?
- Ola Mau i ka Hula
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Kula No Na Po'e
Honolulu, Hawaii, 96813
Adrienne Dillard, PhD, 808-692-1023, ikekupuna@gmail.com
- Recruiting
Kokua Kalihi Valley
Honolulu, Hawaii, 96819
Sheryl Yoshimura, RD, 808-692-1023, ikekupuna@gmail.com
- Recruiting
Hui No Ke Ola Pono
Wailuku, Hawaii, 96793
Malia Purdy, PhD, 808-692-1023, ikekupuna@gmail.com
About this study
Official title: Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project
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.
Read the 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.
- Being tested
- Ola Mau i ka Hula
- 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
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ola Mau i ka HulaBehavioural
Also called Ola Mau
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Ola Mau i ka Hula |
| Wait-list control group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participants' systolic blood pressure at each time frame from baseline
Vascular risk factor assessed using Omron©HEM-907XL
Measured: 3 months, 8 months, 12 months
Change in participants' Hemoglobin A1c at each time frame from baseline
Vascular risk factor assessed using Alere Cholestech LDX® System
Measured: 12 months
Change in participants' total cholesterol at each time frame from baseline
Vascular risk factor assessed using Alere Cholestech LDX® System
Measured: 3 months, 8 months, 12 months
Change in participants' body mass index at each time frame from baseline
Vascular risk factor assessed using Tanita BWB800AS scale
Measured: 3 months, 8 months, 12 months
Change in participants' Cognitive Change Index score at each time frame from baseline
Cognitive function assessed using Cognitive Change Index assessment
Measured: 3 months, 8 months, 12 months
Change in participants' Number Symbol Coding Test score at each time frame from baseline
Cognitive function assessed using Number Symbol Coding Test
Measured: 3 months, 8 months, 12 months
Change in participants' overall Cognivue score at each time frame from baseline
Cognitive function assessed using Cognivue device
Measured: 3 months, 8 months, 12 months
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
Cognitive function assessed using Quick Dementia Rating System assessment
Measured: 3 months, 8 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start15 Sep 2022
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph K Kaholokula, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534607
- Sponsor's protocol ID
- 'Ike Kupuna
- Acronym
- NEAR
- Status last verified
- Jul 2024
- First submitted
- 12 Aug 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project
- ClinicalTrials.gov ID
- NCT05534607
- Acronym / sponsor ID
- NEAR / 'Ike Kupuna
- Keywords
- MCI, Alzheimer's disease, Alzheimer's disease and related dementias, Vascular dementia, ADRD, SCI, Native Hawaiian and Pacific Islander, NHPI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Ola Mau i ka HulaThe 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. |
| Wait-list control group | No 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ola Mau i ka HulaAlso: Ola MauThe 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. | Behavioural | Intervention group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph K Kaholokula, PhD principal investigator
University of Hawaii
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ola Mau i ka Hula in people with Mild Cognitive Impairment and Subjective Cognitive Impairment, run by University of Hawaii at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janice K Worthington, MPH (8086921023, ikekupuna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants' systolic blood pressure at each time frame from baseline (time frame: 3 months, 8 months, 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.