Taekwondo Training and Postmenopausal Women With Stage-2 Hypertension

• Sponsor: Kosin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03544307
• Collaborator: University of Nebraska (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopause; Hypertension	Behavioral: Taekwondo training	N/A

Detailed Description

Using a parallel experimental design, participants were randomly assigned to either a Taekwondo exercise training group (n=10) or non-exercising control group (n=10) for 12 weeks.

Participant in the Taekwondo training group trained 3 days/week for 60 minutes per session, and the intensity progressed weekly. Participants in the control group performed no exercise intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel design with treatment group and controlParallel design with treatment group and control
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Taekwondo Training Reduces Blood Catecholamine Levels and Arterial Stiffness in Postmenopausal Women With Stage-2 Hypertension
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Taekwondo Training 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; Exercise group
No Intervention: Control Sedentary control asked not to exercise

Outcome Measures

Primary Outcome Measures

1. Blood Epinephrine Levels [12-weeks]

2. Blood Norepinephrine Levels [12-weeks]

Secondary Outcome Measures

1. Arterial Stiffness [12-weeks]

   Pulse Wave Velocity

2. Systolic Blood Pressure [12-weeks]

3. Hand Grip Strength [12-weeks]

4. Diastolic Blood Pressure [12-weeks]

5. Leg Strength [12-weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be diagnosed with stage-2 hypertension

• Be postmenopausal

• Be between 65 and 85 years old

Exclusion Criteria:

• Known cardiovascular, metabolic or renal diseases

• Physical limitations that prohibit exercise

• Participates in regular exercise

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Omaha	Omaha	Nebraska	United States	68182

Sponsors and Collaborators

• Kosin University
• University of Nebraska

Investigators

• Principal Investigator: Song Park, University of Nebraska

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 25, 2019

More Information

Publications

None provided.

• Responsible Party: Sang-Ho Lee, Principal Investigator, Kosin University
• ClinicalTrials.gov Identifier: NCT03544307
• Other Study ID Numbers: TaekwondoMenopause
• First Posted: Jun 1, 2018
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sang-Ho Lee, Principal Investigator, Kosin University: Taekwondo; Menopause; Hypertension; Arterial Stiffness; Blood Catecholamines
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Taekwondo Training	Control	Total
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	10 100%	10 100%	20 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (4)	70 (4)	70 (4.7)
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	20 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	10 100%	10 100%	20 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
South Korea	10 100%	10 100%	20 100%
Blood epinephrine levels (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	43.6 (6.6)	43.4 (5.1)	43.5 (5.9)
Blood norepinephrine levels (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	268.6 (41.3)	243.4 (5.1)	256 (23.2)
Arterial stiffness (m/s) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m/s]	8.41 (1.0)	8.27 (0.67)	8.34 (0.84)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	144 (2)	143 (2)	144 (2)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	98 (2)	99 (2)	99 (2)
Hand grip strength (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	24 (4)	25 (4)	25 (4)
Leg strength (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	39 (6)	38 (7)	39 (7)

Outcome Measures

1. Primary Outcome

Title	Blood Epinephrine Levels
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [pg/mL]	39.3 (7.1)	46.2 (4.7)

2. Primary Outcome

Title	Blood Norepinephrine Levels
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [pg/mL]	232.2 (33.7)	330 (38.2)

3. Secondary Outcome

Title	Arterial Stiffness
Description	Pulse Wave Velocity
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [m/s]	7.67 (1.0)	8.48 (1.0)

4. Secondary Outcome

Title	Systolic Blood Pressure
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [mmHg]	130 (2)	142 (2)

5. Secondary Outcome

Title	Hand Grip Strength
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [kilograms (kg)]	27 (3)	24 (4)

6. Secondary Outcome

Title	Diastolic Blood Pressure
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [mmHg]	87 (2)	97 (2)

7. Secondary Outcome

Title	Leg Strength
Time Frame	12-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taekwondo Training	Control
Arm/Group Description	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. Taekwondo training: Exercise group	Sedentary control asked not to exercise
Measure Participants	10	10
Mean (Standard Deviation) [kilograms (kg)]	41 (7)	38 (8)

Adverse Events

Time Frame	6 months
Arm/Group Title	Taekwondo Training		Control
Arm/Group Description	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. Taekwondo training: Exercise group		Sedentary control asked not to exercise
All Cause Mortality
	Taekwondo Training		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Taekwondo Training		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Taekwondo Training		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.