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

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ClinicalTrials.gov Identifier: NCT03534427
Recruitment Status : Completed
First Posted : May 23, 2018
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Songyoung Park, Pusan National University

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE May 23, 2018
Results First Submitted Date  ICMJE March 27, 2019
Results First Posted Date  ICMJE August 14, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE June 5, 2016
Actual Primary Completion Date February 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Arterial Stiffness [ Time Frame: 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.
  • Endothelin-1 [ Time Frame: 12 weeks ]
    Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.
  • Body Mass [ Time Frame: 12 weeks ]
    Body mass was measured to nearest 0.1 kg.
  • Height [ Time Frame: 12 weeks ]
    Height was measured to nearest 1 cm.
  • Waist Circumference [ Time Frame: 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.
  • Body Fat [ Time Frame: 12 weeks ]
    Percent body fat (%) was determined using a bioelectrical impedance-meter.
  • Lean Body Mass [ Time Frame: 12 weeks ]
    Lean body mass (kg) was determined using a bioelectrical impedance-meter.
  • Nitrate/Nitrite Levels [ Time Frame: 12 weeks ]
    Nitrate and nitrite levels were assayed using a Griess assay kit.
  • C-reactive Protein [ Time Frame: 12 weeks ]
    C-reactive protein was assessed using an enzyme immunoassay assay kit
  • Systolic Blood Pressure [ Time Frame: 12 weeks ]
    Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the two was recorded as the resting blood pressure.
  • Diastolic Blood Pressure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • Arterial stiffness [ Time Frame: 12 weeks ]
    Arterial stiffness was measured as measurement of baPWV (m/s).
  • Endothelin-1 [ Time Frame: 12 weeks ]
    Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.
  • Body Mass [ Time Frame: 12 weeks ]
    Body mass was measured to nearest 0.1 kg.
  • Height [ Time Frame: 12 weeks ]
    Height was measured to nearest 1 cm.
  • Waist Circumference [ Time Frame: 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.
  • Body Fat [ Time Frame: 12 weeks ]
    Percent body fat (%) was determined using a bioelectrical impedance-meter.
  • Lean Body Mass [ Time Frame: 12 weeks ]
    Lean body mass (kg) was determined using a bioelectrical impedance-meter.
  • Nitrate/Nitrite Levels [ Time Frame: 12 weeks ]
    Nitrate and nitrite levels were assayed using a Griess assay kit.
  • C-reactive Protein [ Time Frame: 12 weeks ]
    C-reactive protein was assessed using an enzyme immunoassay assay kit
  • Blood pressure [ Time Frame: 12 weeks ]
    Blood pressure was measured using an automated sphygmomanometer.
Change History Complete list of historical versions of study NCT03534427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of a Jump Rope Exercise Program on Vascular Health, Inflammatory Markers in Prehypertensive Adolescent Girls
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
exercise intervention group, control group
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Prehypertension
  • Blood Pressure
  • Abdominal Obesity
  • Adiposity
Intervention  ICMJE Other: Jump rope exercise intervention
12-week jump rope exercise program
Study Arms  ICMJE
  • 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.
    Intervention: Other: Jump rope exercise intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 21, 2018
Actual Primary Completion Date February 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 14 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03534427
Other Study ID Numbers  ICMJE PusanNU1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Songyoung Park, Pusan National University
Study Sponsor  ICMJE Pusan National University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pusan National University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP