PrehypertensionNCT03534427
The Effects of a Jump Rope Exercise Program on Vascular Health, Inflammatory Markers in Prehypertensive Adolescent Girls
A study testing Jump rope exercise intervention in people with Prehypertension and Blood Pressure, run by Pusan National University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Blood Pressure, Abdominal Obesity
- What is being tested?
- Jump rope exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2011to 21 Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- prehypertensive
- sedentary (no regular exercise training or physical activity within the last year)
- no weight loss diet during the last six months
Who cannot join
- pregnancy
- chronic disease
- daily medication use (including antioxidants and weight loss supplements)
About this study
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
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.
- Conditions
- Prehypertension, Blood Pressure, Abdominal Obesity, Adiposity
- Being tested
- Jump rope exercise intervention
- Keywords
- arterial stiffness, endothelin-1, c-reactive protein, adiposity, exercise, jump rope
- Medical subject headings
- Prehypertension, Obesity, Abdominal, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jump rope exercise interventionOther
12-week jump rope exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Jump rope exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Endothelin-1
Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.
Measured: 12 weeks
Body Mass
Body mass was measured to nearest 0.1 kg.
Measured: 12 weeks
Height
Height was measured to nearest 1 cm.
Measured: 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.
Measured: 12 weeks
Body Fat
Percent body fat (%) was determined using a bioelectrical impedance-meter.
Measured: 12 weeks
Lean Body Mass
Lean body mass (kg) was determined using a bioelectrical impedance-meter.
Measured: 12 weeks
Nitrate/Nitrite Levels
Nitrate and nitrite levels were assayed using a Griess assay kit.
Measured: 12 weeks
C-reactive Protein
C-reactive protein was assessed using an enzyme immunoassay assay kit
Measured: 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.
Measured: 12 weeks
Diastolic Blood Pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start5 Jun 2011
- Primary completion10 Feb 2012
- Study completion21 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- exercise intervention group, control group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534427
- Sponsor's protocol ID
- PusanNU1
- Status last verified
- Oct 2020
- First submitted
- 11 May 2018
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03534427
- Acronym / sponsor ID
- PusanNU1
- Conditions
- Prehypertension, Blood Pressure, Abdominal Obesity, Adiposity
- Keywords
- arterial stiffness, endothelin-1, c-reactive protein, adiposity, exercise, jump rope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Study start
- 5 Jun 2011 (actual)
- Primary completion
- 10 Feb 2012 (actual)
- Study completion
- 21 Mar 2012 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- exercise intervention group, control group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No exercise intervention |
| Jump rope exercise intervention | Experimental | Other: Jump rope exercise interventionThe 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. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- prehypertensive
- sedentary (no regular exercise training or physical activity within the last year)
- no weight loss diet during the last six months
Key exclusion criteria (3 listed)
- pregnancy
- chronic disease
- daily medication use (including antioxidants and weight loss supplements)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jump rope exercise intervention12-week jump rope exercise program | Other | Jump rope exercise intervention |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prehypertension
Not yet recruiting
Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
Prehypertension
Recruiting
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Prehypertension (Elevated Blood Pressure) or Hypertension, Healthy
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Adverse Event
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Jump rope exercise intervention in people with Prehypertension and Blood Pressure, run by Pusan National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.