NCT03544307

Brief Summary

Aging is associated with hormonal imbalances and progressive decreases in arterial health and function. It is crucial to prevent or reduce the negative effects of aging on hormonal balance and the vasculature by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a 12-week Taekwondo training program on blood catecholamines, arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), resting heart rate, and muscular strength in postmenopausal women with stage 2 hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

May 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

May 18, 2018

Results QC Date

March 27, 2019

Last Update Submit

November 8, 2020

Conditions

Keywords

TaekwondoMenopauseHypertensionArterial StiffnessBlood Catecholamines

Outcome Measures

Primary Outcomes (2)

  • Blood Epinephrine Levels

    12-weeks

  • Blood Norepinephrine Levels

    12-weeks

Secondary Outcomes (5)

  • Arterial Stiffness

    12-weeks

  • Systolic Blood Pressure

    12-weeks

  • Hand Grip Strength

    12-weeks

  • Diastolic Blood Pressure

    12-weeks

  • Leg Strength

    12-weeks

Study Arms (2)

Taekwondo Training

EXPERIMENTAL

Taekwondo training was performed 60 minutes/day, 3 days/week for 12-weeks. Exercise intensity was set at 30-40% of heart rate reserve (HRR) and gradually increased to 50-60% over 12 weeks.

Behavioral: Taekwondo training

Control

NO INTERVENTION

Sedentary control asked not to exercise

Interventions

Exercise group

Taekwondo Training

Eligibility Criteria

Age65 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgender identity
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be diagnosed with stage-2 hypertension
  • Be postmenopausal
  • Be between 65 and 85 years old

You may not qualify if:

  • Known cardiovascular, metabolic or renal diseases
  • Physical limitations that prohibit exercise
  • Participates in regular exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Song-Young Park
Organization
The University of Nebraska at Omaha

Study Officials

  • Song Park

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel design with treatment group and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 1, 2018

Study Start

May 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 10, 2020

Results First Posted

August 5, 2019

Record last verified: 2020-11

Locations