PrehypertensionNCT03898518
The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls
A study testing 12-week jump rope exercise program 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 body composition, blood pressure, insulin resistance, and academic self-efficacy in prehypertensive adolescent obese girls. Forty-eight prehypertensive adolescent obese girls participated in this study. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Blood Pressure, Abdominal Obesity
- What is being tested?
- 12-week jump rope exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2010to 6 Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- 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
- obese
Who cannot join
- pregnancy
- chronic disease
- daily medication use
About this study
Official title: The Effects of a 12-week Jump Rope Exercise Program on Body Composition, Insulin Sensitivity, and Academic Self-efficacy in Obese Prehypertensive Adolescent Girls
The purpose of this study was to examine the impact of a 12-week jump rope exercise program on body composition, blood pressure, insulin resistance, and academic self-efficacy in prehypertensive adolescent obese girls. Forty-eight prehypertensive adolescent obese girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=24) and control group (CON, n=24). 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 structure or unstructured exercise protocol. Blood pressure, body fat percentage, waist circumference, blood glucose and insulin, homeostatic model assessment - insulin resistance, and Academic Self-Efficacy were measured before and after the 12-weeks study.
- Conditions
- Prehypertension, Blood Pressure, Abdominal Obesity, Self Efficacy, Adiposity, Insulin Sensitivity
- Being tested
- 12-week jump rope exercise program
- Keywords
- adolescence, exercise, body composition, insulin sensitivity, obesity, academic self-efficacy
- Medical subject headings
- Prehypertension, Obesity, Abdominal, Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week jump rope exercise programOther
Each jump rope exercise session of the program was performed for 50 minute, with a 5 minute warm-up and cool-down. Sessions were performed once a day, 5 days 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 form 40-50% heart rate reserve (HRR) in weeks 1-4 and 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Ever subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group was in the facility for all jump rope exercise sessions but did not participate in the exercise intervention. |
| Experimental Group | Experimental | The experimental group performed the jump rope exercise intervention. Receives: Other: 12-week jump rope exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Body fat percentage was measured to the nearest 0.1%.
Measured: 12 weeks
Blood Pressure
Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the was recorded as the resting blood pressure. Both systolic and diastolic blood pressure were recorded.
Measured: 12 weeks
Body Mass
Body mass was measured to nearest 0.1kg.
Measured: 12 weeks
Height
Height was measured to the nearest 1 cm.
Measured: 12 weeks
Waist Circumference
Waist circumference as measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tap measure.
Measured: 12 weeks
Lean Body Mass
Lean body mass (kg) was determined using a bioelectrical impedance-meter.
Measured: 12 weeks
Glucose
Blood glucose concentrations were assessed with a glucose reagent kit.
Measured: 12 weeks
Insulin
Serum insulin was evaluated using an enzyme-linked immunosorbent assay (ELISA) kit.
Measured: 12 weeks
Homeostatic Model Assessment - Insulin Resistance
Homeostatic model assessment - insulin resistance was calculated from the fasting plasma blood glucose and insulin levels according to previously established models.
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 posted2 Apr 2019
- Study start3 Oct 2010
- Primary completion23 Feb 2011
- Study completion6 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University, University of Nebraska
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898518
- Sponsor's protocol ID
- UNOVRLJRSE
- Status last verified
- Oct 2020
- First submitted
- 29 Mar 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 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 Program on Body Composition, Insulin Sensitivity, and Academic Self-efficacy in Obese Prehypertensive Adolescent Girls
- ClinicalTrials.gov ID
- NCT03898518
- Acronym / sponsor ID
- UNOVRLJRSE
- Conditions
- Prehypertension, Blood Pressure, Abdominal Obesity, Self Efficacy, Adiposity, Insulin Sensitivity
- Keywords
- adolescence, exercise, body composition, insulin sensitivity, obesity, academic self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Chonnam National University, University of Nebraska
- Study start
- 3 Oct 2010 (actual)
- Primary completion
- 23 Feb 2011 (actual)
- Study completion
- 6 Dec 2011 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
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 body composition, blood pressure, insulin resistance, and academic self-efficacy in prehypertensive adolescent obese girls. Forty-eight prehypertensive adolescent obese girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=24) and control group (CON, n=24). 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 structure or unstructured exercise protocol. Blood pressure, body fat percentage, waist circumference, blood glucose and insulin, homeostatic model assessment - insulin resistance, and Academic Self-Efficacy 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 | –The control group was in the facility for all jump rope exercise sessions but did not participate in the exercise intervention. |
| Experimental Group | Experimental | Other: 12-week jump rope exercise programThe experimental group performed the jump rope exercise intervention. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- prehypertensive
- sedentary (no regular exercise training or physical activity within the last year)
- no weight loss diet during the last six months
- obese
Key exclusion criteria (3 listed)
- pregnancy
- chronic disease
- daily medication use
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 |
|---|---|---|
| 12-week jump rope exercise programEach jump rope exercise session of the program was performed for 50 minute, with a 5 minute warm-up and cool-down. Sessions were performed once a day, 5 days 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 form 40-50% heart rate reserve (HRR) in weeks 1-4 and 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Ever subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity. | Other | Experimental Group |
Primary outcome
Body Fat
Time frame: 12 weeks
Body fat percentage was measured to the nearest 0.1%.
Blood Pressure
Time frame: 12 weeks
Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the was recorded as the resting blood pressure. Both systolic and diastolic blood pressure were recorded.
Body Mass
Time frame: 12 weeks
Body mass was measured to nearest 0.1kg.
Height
Time frame: 12 weeks
Height was measured to the nearest 1 cm.
Waist Circumference
Time frame: 12 weeks
Waist circumference as measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tap measure.
Lean Body Mass
Time frame: 12 weeks
Lean body mass (kg) was determined using a bioelectrical impedance-meter.
Glucose
Time frame: 12 weeks
Blood glucose concentrations were assessed with a glucose reagent kit.
Insulin
Time frame: 12 weeks
Serum insulin was evaluated using an enzyme-linked immunosorbent assay (ELISA) kit.
Homeostatic Model Assessment - Insulin Resistance
Time frame: 12 weeks
Homeostatic model assessment - insulin resistance was calculated from the fasting plasma blood glucose and insulin levels according to previously established models.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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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 12-week jump rope exercise program 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 4 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 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Fat (time frame: 12 weeks). The study lists 9 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 3 Nov 2020.