NCT03534427

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2012

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 14, 2019

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

May 11, 2018

Results QC Date

March 27, 2019

Last Update Submit

October 27, 2020

Conditions

Keywords

arterial stiffnessendothelin-1c-reactive proteinadiposityexercisejump rope

Outcome Measures

Primary Outcomes (11)

  • Arterial Stiffness

    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.

    12 weeks

  • Endothelin-1

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

    12 weeks

  • Body Mass

    Body mass was measured to nearest 0.1 kg.

    12 weeks

  • Height

    Height was measured to nearest 1 cm.

    12 weeks

  • Waist Circumference

    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.

    12 weeks

  • Body Fat

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

    12 weeks

  • Lean Body Mass

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

    12 weeks

  • Nitrate/Nitrite Levels

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

    12 weeks

  • C-reactive Protein

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

    12 weeks

  • Systolic Blood Pressure

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

    12 weeks

  • Diastolic Blood Pressure

    12 weeks

Study Arms (2)

Control group

NO INTERVENTION

No exercise intervention

Jump rope exercise intervention

EXPERIMENTAL

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

Interventions

12-week jump rope exercise program

Jump rope exercise intervention

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • prehypertensive
  • sedentary (no regular exercise training or physical activity within the last year)
  • no weight loss diet during the last six months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PrehypertensionObesity, AbdominalObesityMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: exercise intervention group, control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

June 5, 2011

Primary Completion

February 10, 2012

Study Completion

March 21, 2012

Last Updated

October 29, 2020

Results First Posted

August 14, 2019

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share