NCT01995812

Brief Summary

Physical activity is an important lifestyle modification for individuals with high blood pressure. It is part of national cardiac care guidelines for hypertension management that recommends, along with prescribing medication, lifestyle modification be promoted for improved dietary intake, and participation in about 150 minutes of moderate exercise a week. Native Hawaiians and other Pacific peoples (NHPP) have among the highest risk for the heart disease, with mortality rates twice other ethnic groups. In many minority populations, including NHPP, hypertension develops at an early age, is more severe and is less likely to be controlled. Despite the ability of physical activity to reduce blood pressure, the majority of U.S. population, do not meet physical activity recommendations and new interventions that can improve accessibility and adherence, particularly among at-risk minority populations are needed. In this research, Hypertension and Hula: Ola Hou Pilot Study, we plan to evaluate a culturally relevant intervention that uses hula and is consistent with the goals of recommended physical activity for improved lifestyle - moderate-intensity, prolonged physical activity cumulatively at about 150 minutes per week. Hula, the traditional dance form of Native Hawaiians, is commonly practiced in Hawai'i as a cultural practice, form of creative expression, and exercise that is structured on controlled, rhythmic movements. Combining aspects of meditation, music, self-awareness with low-impact aerobic exercise, traditional hula may be particularly suitable to individuals with limited mobility and fitness and within the recommended paradigm for exercise training and secondary prevention of coronary artery disease (CAD). We anticipate a hula and heart health education program will be particularly appealing to Native Hawaiians and other Pacific people (NHPP) including Pacific Islanders and Filipino who suffer from a significant disparity in cardiovascular health. Specifically, we will determine if individuals with poorly managed hypertension and randomized to a 12-week hula and heart health education intervention will demonstrate better blood pressure levels, functional capacity, and exercise tolerance (6-minute walk test) than individuals randomized to a usual care group. We will also assess if the individuals in the hula intervention report better health-related quality of life, stress management, perceptions of discrimination, and exercise self efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

November 18, 2013

Last Update Submit

November 21, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction of systolic blood pressure in hypertensive participants

    3 months

Secondary Outcomes (1)

  • Health-related quality of life

    3 months

Study Arms (2)

Hula and heart health education

EXPERIMENTAL

12 weeks of hula classes, 2 times a week for one hour. An additional 3 hours of heart health education was given to participants

Behavioral: Hula and heart health education

Control group

NO INTERVENTION

Interventions

Hula and heart health education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (age \> 18) with blood pressure \>140/90 or \>130/80 if also diagnosed with diabetes
  • Under a physicians care for hypertension for at least 6 months
  • Prescribed 2-3 hypertension medications
  • Independently ambulatory
  • Approval of participation from primary care physician or cardiologist

You may not qualify if:

  • Prescribed more than 4, or only 1 hypertension medication
  • Severe cognitive dysfunction precluding informed consent and understanding of hula
  • Pregnancy at time or during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii, John A Burns School of Medicine, Department of Native Hawaiian Health

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

  • Kaholokula JK, Look M, Mabellos T, Zhang G, de Silva M, Yoshimura S, Solatorio C, Wills T, Seto TB, Sinclair KA. Cultural Dance Program Improves Hypertension Management for Native Hawaiians and Pacific Islanders: a Pilot Randomized Trial. J Racial Ethn Health Disparities. 2017 Feb;4(1):35-46. doi: 10.1007/s40615-015-0198-4. Epub 2015 Dec 22.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Associate Professor

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 27, 2013

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations