The Effects of a Jump Rope Exercise Program on Vascular Health, Inflammatory Markers in Prehypertensive Adolescent Girls

• Sponsor: Pusan National University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03534427
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Actual Duration (Months): 9.5

Study Details

Study Description

Brief Summary

The purpose of this study was to examine the impact of a 12-week jump rope exercise program on blood pressure, arterial stiffness, vasodilating and vasoconstricting factors, inflammatory markers, and body composition in prehypertensive adolescent girls. Forty prehypertensive adolescent girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=20) and control group (CON, n=20). The EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate in any structured or unstructured exercise protocol. Blood pressure, arterial stiffness, plasma nitrate/nitrite levels, endothelin-1, C-reactive protein, and body composition were measured before and after the 12-weeks study.

Condition or Disease	Intervention/Treatment	Phase
Prehypertension; Blood Pressure; Abdominal Obesity; Adiposity	Other: Jump rope exercise intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: exercise intervention group, control groupexercise intervention group, control group
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Effects of a 12-Week Jump Rope Exercise Training Program on Arterial Stiffness, Vasodilating and Vasoconstricting Factors, Inflammatory Markers, and Body Composition in Prehypertensive Adolescent Girls
• Actual Study Start Date: Jun 5, 2011
• Actual Primary Completion Date: Feb 10, 2012
• Actual Study Completion Date: Mar 21, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group No exercise intervention
Experimental: Jump rope exercise intervention The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.	Other: Jump rope exercise intervention; 12-week jump rope exercise program

Outcome Measures

Primary Outcome Measures

1. Arterial Stiffness [12 weeks]

   Arterial stiffness was measured as measurement of brachial to ankle pulse-wave velocity. This indicates peripheral arterial stiffness, as it measures how quickly a pulse wave propagates from one point to another.

2. Endothelin-1 [12 weeks]

   Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.

3. Body Mass [12 weeks]

   Body mass was measured to nearest 0.1 kg.

4. Height [12 weeks]

   Height was measured to nearest 1 cm.

5. Waist Circumference [12 weeks]

   Waist circumference was measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tape measure.

6. Body Fat [12 weeks]

   Percent body fat (%) was determined using a bioelectrical impedance-meter.

7. Lean Body Mass [12 weeks]

   Lean body mass (kg) was determined using a bioelectrical impedance-meter.

8. Nitrate/Nitrite Levels [12 weeks]

   Nitrate and nitrite levels were assayed using a Griess assay kit.

9. C-reactive Protein [12 weeks]

   C-reactive protein was assessed using an enzyme immunoassay assay kit

10. Systolic Blood Pressure [12 weeks]

    Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the two was recorded as the resting blood pressure.

11. Diastolic Blood Pressure [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 16 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• prehypertensive

• sedentary (no regular exercise training or physical activity within the last year)

• no weight loss diet during the last six months

Exclusion Criteria:

• pregnancy

• chronic disease

• daily medication use (including antioxidants and weight loss supplements)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pusan National University

Investigators

None specified.

Study Documents (Full-Text)

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

More Information

Publications

None provided.

• Responsible Party: Won-mok son, Principal Investigator, Pusan National University
• ClinicalTrials.gov Identifier: NCT03534427
• Other Study ID Numbers: PusanNU1
• First Posted: May 23, 2018
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Won-mok son, Principal Investigator, Pusan National University: arterial stiffness; endothelin-1; c-reactive protein; adiposity; exercise; jump rope
• Additional relevant MeSH terms: Prehypertension; Obesity; Obesity, Abdominal

Study Results

Participant Flow

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Jump Rope Exercise Intervention	Total
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.1 (1.2)	15.3 (0.9)	15.1 (1.0)
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	40 100%
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	20 100%	20 100%	40 100%
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	20 100%	20 100%	40 100%
Arterial stiffness (m/s) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m/s]	8.2 (0.5)	8.2 (1)	8.2 (0.8)
Endothelin-1 (umol/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [umol/mL]	0.41 (0.21)	0.37 (0.21)	0.40 (0.21)
Body mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	68 (8)	69 (9.4)	68.5 (8.7)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	161 (3)	160 (3)	160.5 (3)
Waist circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	85.3 (4)	86.4 (4)	85.9 (4)
Body Fat (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	32.7 (3.2)	33.8 (3.6)	33.3 (3.4)
Lean Body Mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	43.7 (4.2)	44.9 (4.5)	44.3 (4.3)
Nitrate/Nitrite Levels (umol) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [umol]	53.3 (4.3)	54.5 (5.1)	53.9 (4.7)
C-reactive protein (mg/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/L]	0.5 (0.3)	0.5 (0.4)	0.5 (0.4)
Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	126 (4.2)	126 (3.3)	126 (3.8)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	82 (2)	82 (0.4)	82 (1.3)

Outcome Measures

1. Primary Outcome

Title	Arterial Stiffness
Description	Arterial stiffness was measured as measurement of brachial to ankle pulse-wave velocity. This indicates peripheral arterial stiffness, as it measures how quickly a pulse wave propagates from one point to another.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [m/s]	8.1 (0.2)	7.4 (0.2)

2. Primary Outcome

Title	Endothelin-1
Description	Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [umol/mL]	0.4 (0.31)	0.38 (0.33)

3. Primary Outcome

Title	Body Mass
Description	Body mass was measured to nearest 0.1 kg.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [kilograms (kg)]	70 (8.9)	66 (7.3)

4. Primary Outcome

Title	Height
Description	Height was measured to nearest 1 cm.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [cm]	162 (4)	161 (3)

5. Primary Outcome

Title	Waist Circumference
Description	Waist circumference was measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tape measure.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [cm]	84.4 (5.2)	80.1 (4.8)

6. Primary Outcome

Title	Body Fat
Description	Percent body fat (%) was determined using a bioelectrical impedance-meter.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [percent]	33.5 (3.7)	30.2 (3.1)

7. Primary Outcome

Title	Lean Body Mass
Description	Lean body mass (kg) was determined using a bioelectrical impedance-meter.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [kilograms (kg)]	42.8 (6.5)	45.9 (6.7)

8. Primary Outcome

Title	Nitrate/Nitrite Levels
Description	Nitrate and nitrite levels were assayed using a Griess assay kit.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [umol]	53.5 (5.2)	57.2 (5.2)

9. Primary Outcome

Title	C-reactive Protein
Description	C-reactive protein was assessed using an enzyme immunoassay assay kit
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [mg/L]	0.7 (0.4)	0.2 (0.1)

10. Primary Outcome

Title	Systolic Blood Pressure
Description	Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the two was recorded as the resting blood pressure.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [mmHg]	127 (5.3)	120 (2.1)

11. Primary Outcome

Title	Diastolic Blood Pressure
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention	The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
Measure Participants	20	20
Mean (Standard Deviation) [mmHg]	84 (1.9)	80 (2)

Adverse Events

Time Frame	6 months
Arm/Group Title	Control Group		Jump Rope Exercise Intervention
Arm/Group Description	No exercise intervention		The jump rope exercise program was performed for 50 minutes with 5 minutes of warm-up and cool-down per day, 5 times a week for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4 and to 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Every subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. Jump rope exercise intervention: 12-week jump rope exercise program
All Cause Mortality
	Control Group		Jump Rope Exercise Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Control Group		Jump Rope Exercise Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Jump Rope Exercise Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (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.