Hula for Cognitive Impairment

(NEAR Trial)

Recruiting at 2 trial locations

Overseen By Jetney K Vehas, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Pregnancy, Active hula practice, ADRD, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

192 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ola Mau i ka Hula for cognitive impairment?

Research shows that lifestyle modifications, including physical exercise and mind-body activities, can help maintain cognitive function in people with mild cognitive impairment. Additionally, traditional medicine approaches, like those used in Korean medicine, have shown improvements in cognitive assessments, suggesting that similar treatments might be beneficial. ^{1 2 3 4 5}

Is Hula for Cognitive Impairment safe for humans?

There is no specific safety data available for Hula for Cognitive Impairment or its related treatments like Ola Mau i ka Hula. However, studies on similar treatments, such as Chinese herbal medicine and acupuncture for cognitive impairment, reported no severe adverse events, suggesting these types of interventions are generally safe. ^{4 6 7 8 9}

How is the treatment Ola Mau i ka Hula unique for cognitive impairment?

Ola Mau i ka Hula is unique because it incorporates hula, a traditional Hawaiian dance, as a holistic treatment that integrates physical, mental, emotional, and spiritual well-being, unlike conventional treatments that may focus solely on medication or cognitive exercises. ^{10 11 12 13 14}

Research Team

Joseph K Kaholokula, PhD

Principal Investigator

University of Hawaii

Eligibility Criteria

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.

Inclusion Criteria

Self-reported Native Hawaiian or other Pacific Islander ancestry

Has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI)

Physically able and willing to engage in moderate physical activity necessary for Hula

Exclusion Criteria

Already actively practicing Hula at least once per week

Currently pregnant

I have been diagnosed with moderate or severe depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive the Ola Mau i ka Hula intervention for 8 months followed by a 4-month self-monitoring period

12 months

Regular visits for intervention and monitoring

Wait-list Control

Participants in the wait-list control group do not receive the intervention during the initial 12 months but continue with routine medical care

12 months

Follow-up

Participants are monitored for changes in cognitive and vascular risk factors after the intervention period

12 months

Assessments at 3, 8, and 12 months

Treatment Details

Interventions

• Ola Mau i ka Hula

Trial Overview 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).

Participant Groups

Group I: Intervention group Experimental Treatment 1 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 group Active Control 1 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 Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

Findings from Research

In a 12-month randomized controlled trial with 72 older adults, DHA fish oil supplements did not show a significant effect on cognitive measures, indicating that not all cognitively impaired older adults may benefit from DHA supplementation.

However, the study found that DHA supplementation positively impacted systolic blood pressure and reduced depression and anxiety scores in carriers of the APOE ɛ4 allele, suggesting potential benefits in mood and cardiovascular health for this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of docosahexaenoic acid supplementation on cognition and well-being in mild cognitive impairment: A 12-month randomised controlled trial. Mengelberg, A., Leathem, J., Podd, J., et al.[2022]

In a 4-year study of 789 elderly individuals with mild cognitive impairment (MCI), 30.9% reverted to normal cognitive function, highlighting the potential for recovery in this population.

The study identified five patterns of modifiable risk factors, with those in the 'low risk' category showing a significantly higher likelihood of recovery from MCI, suggesting targeted interventions could help prevent cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifiable Risk Factor Possession Patterns of Dementia in Elderly with MCI: A 4-Year Repeated Measures Study. Katayama, O., Lee, S., Bae, S., et al.[2020]

In a study involving 24 group sessions with people with mild cognitive impairment (MCI) and their care partners, withholding yoga from the Mayo Clinic HABIT program resulted in the greatest decline in functional ability over 18 months, highlighting the importance of physical exercise in maintaining cognitive function.

Memory compensation training and cognitive exercises were associated with better functional outcomes, suggesting that specific lifestyle modifications can effectively support individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effects of Physical Exercise and Other Behavioral Interventions on Functional Status Outcomes in Mild Cognitive Impairment. Shandera-Ochsner, AL., Chandler, MJ., Locke, DE., et al.[2022]

In a study involving 15 patients with amnestic mild cognitive impairment, treatment with Korean medicine, including herbal medicine and acupuncture, led to a significant improvement in cognitive ability as measured by the K-MoCA score after 12 and 24 weeks.

While the K-MMSE score showed a slight increase, it was not statistically significant, indicating that the K-MoCA may be a more sensitive measure for detecting cognitive improvements in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Korean Traditional Medicine in Treating Patients with Mild Cognitive Impairment: A Multicenter Prospective Observational Case Series. Choi, Y., Kim, YE., Jerng, UM., et al.[2020]

The pilot study involving 19 older adults with mild cognitive impairment (MCI) showed that combining cognitive training, mind-body exercise, and nurse-led risk factor modification (CPR) was feasible and had preliminary benefits, particularly in reducing cognitive decline and improving quality of life.

The nurse-led risk factor modification (RFM) group demonstrated significant improvements in cognitive scores, while the CPR group showed reductions in health service costs, indicating that both interventions could be effective strategies for managing MCI in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care. Xu, Z., Zhang, D., Lee, ATC., et al.[2022]

In a 6-month randomized trial with 90 patients suffering from vascular cognitive impairment, Ginkgo biloba extract (both 120 mg and 60 mg) showed a significant positive effect on cognitive function as measured by the Clinical Global Impression score compared to placebo.

While Ginkgo biloba did not show significant improvements in other cognitive tests or ultrasound findings, it had fewer adverse reactions compared to the placebo group, suggesting it may be a safe option for patients, though further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial. Demarin, V., Bašić Kes, V., Trkanjec, Z., et al.[2023]

A review of 10 randomized controlled trials found that various Chinese herbal medicines (CHM) showed overall benefits for Mild Cognitive Impairment (MCI) and Age Associated Memory Impairment (AAMI), with some CHMs performing at least as well as the drug piracetam on cognitive assessments like the Mini-Mental State Examination (MMSE).

The studies included in the review did not report any severe adverse events, suggesting that CHMs may be a safe option for improving cognitive function in individuals with MCI and AAMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese herbal medicine for Mild Cognitive Impairment and Age Associated Memory Impairment: a review of randomised controlled trials. May, BH., Yang, AW., Zhang, AL., et al.[2009]

In a 42-month study involving 118 cognitively intact elderly participants, Ginkgo biloba extract (GBE) did not significantly reduce the risk of progressing to mild cognitive impairment or decline in memory function in the overall analysis.

However, when accounting for medication adherence, GBE showed a protective effect against cognitive decline, but it was also associated with a higher incidence of ischemic strokes and transient ischemic attacks (TIAs), indicating potential safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of Ginkgo biloba for the prevention of cognitive decline. Dodge, HH., Zitzelberger, T., Oken, BS., et al.[2022]

A systematic review of 12 randomized controlled trials involving 691 participants found that acupuncture, especially when combined with cognitive function training, significantly improves cognitive function in patients with vascular mild cognitive impairment (VMCI).

Acupuncture demonstrated better therapeutic effects compared to Western medicine alone, and importantly, no adverse events were reported in any of the studies, suggesting it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating vascular mild cognitive impairment by acupuncture: a systematic review of randomized controlled trials]. Zhou, L., Zhang, YL., Cao, HJ., et al.[2022]

Interviews with six kumu hula from five Hawaiian Islands revealed strong support for using hula in cardiovascular disease (CVD) intervention programs, highlighting its deep connections to health and well-being.

The kumu hula emphasized the importance of maintaining hula's cultural integrity in clinical interventions, suggesting that when done respectfully, hula can serve as an effective holistic approach to improving overall health and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kumu hula perspectives on health. Look, MA., Maskarinec, GG., de Silva, M., et al.[2018]

A Polynesian version of the Mini-Mental State Examination (P-MMSE) was developed and validated using a sample of 112 healthy individuals, ensuring cultural relevance for French Polynesia.

The P-MMSE demonstrated strong diagnostic performance for detecting Alzheimer disease, with a general cut-off score of ≤23 achieving 82% sensitivity and 75% specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Polynesian adaptation of the Mini-Mental State Examination]. Wong, H., Larre, P., Ghawché, F.[2019]

The CERAD Neuropsychology Battery effectively differentiates between nondemented and demented Japanese Americans, based on a study involving 350 participants from Seattle and 418 from Hawaii, both aged 65 and older.

While the battery can identify dementia presence, it is less effective at distinguishing between different severity levels of dementia, indicating a need for more tailored cognitive measures for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance on the CERAD neuropsychology battery of two samples of Japanese-American elders: norms for persons with and without dementia. Fillenbaum, GG., McCurry, SM., Kuchibhatla, M., et al.[2022]

Health-care providers identified significant barriers for Pacific peoples in New Zealand facing age-related cognitive decline, including limited access to services and difficulties in obtaining accurate diagnoses due to inconsistent access to general practitioners.

Communication challenges were prevalent, as many Pacific patients struggled to find information in their native languages, highlighting a gap in culturally appropriate resources and support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The needs of Pacific families affected by age-related cognitive impairment in New Zealand: interviews with providers from health-care organisations. Symon, V., Richards, R., Norris, P., et al.[2022]

The Puni Ke Ola intervention, aimed at preventing substance use in Native Hawaiian communities, faced several implementation challenges, including issues with scheduling, participant recruitment, and communication.

Despite these challenges, the community-academic partnership team emphasized the importance of 'Kapu Aloha'—practicing love and compassion—which helped them navigate difficulties and can inform future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Lessons Learned in Implementing a Community-Academic Partnership for Drug Prevention in a Native Hawaiian Community. Helm, S., Davis, K., Haumana, AYP.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of docosahexaenoic acid supplementation on cognition and well-being in mild cognitive impairment: A 12-month randomised controlled trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Modifiable Risk Factor Possession Patterns of Dementia in Elderly with MCI: A 4-Year Repeated Measures Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Comparative Effects of Physical Exercise and Other Behavioral Interventions on Functional Status Outcomes in Mild Cognitive Impairment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Korean Traditional Medicine in Treating Patients with Mild Cognitive Impairment: A Multicenter Prospective Observational Case Series. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Chinese herbal medicine for Mild Cognitive Impairment and Age Associated Memory Impairment: a review of randomised controlled trials. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of Ginkgo biloba for the prevention of cognitive decline. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Treating vascular mild cognitive impairment by acupuncture: a systematic review of randomized controlled trials]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Kumu hula perspectives on health. [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Polynesian adaptation of the Mini-Mental State Examination]. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Performance on the CERAD neuropsychology battery of two samples of Japanese-American elders: norms for persons with and without dementia. [2022]

13. Australia pubmed.ncbi.nlm.nih.gov

The needs of Pacific families affected by age-related cognitive impairment in New Zealand: interviews with providers from health-care organisations. [2022]

14. Puerto Rico pubmed.ncbi.nlm.nih.gov

Challenges and Lessons Learned in Implementing a Community-Academic Partnership for Drug Prevention in a Native Hawaiian Community. [2018]