Obesity, AdolescentNCT03146026
The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.
A study testing Combined Exercise Training in people with Obesity, Adolescent, run by Pusan National University.
Trial summary
The purpose of this study was to examine the impact of 12 weeks of combined exercise training (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. Thirty obese adolescent girls participated in this study. 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
- Obesity, Adolescent
- What is being tested?
- Combined Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2010to 6 May 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
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Obese with hyperinsulinemia
- Abdominal obesity
- Sedentary (no regular exercise training or physical activity)
- No weight loss diet during last 6 months.
Who cannot join
- Hypertension
- Pregnancy
- Chronic disease
About this study
Official title: The Effects of a 12- Week Combined Exercise Training Program on Arterial Stiffness, Endothelial Function, Inflammatory Markers and Metabolic Profile in Obese Adolescent Girls: A Pilot Study.
The purpose of this study was to examine the impact of 12 weeks of combined exercise training (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. Thirty obese adolescent girls participated in this study. The girls were randomly divided into CET group (n=15) and control group (n=15). The CET group performed concurrent resistance training followed by aerobic training at 40-70% of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1, C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after the 12-weeks study.
- Conditions
- Obesity, Adolescent
- Being tested
- Combined Exercise Training
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Exercise TrainingBehavioural
The CET program was performed for 60 minutes with 5 minutes of warm-up and cool-down per day, 3 times a week for 12 weeks. Combined exercise consisted of 20 minutes of various resistant band exercises (Upper body: seated rows, biceps curl, shoulder flexion, elbow flexion, chest press; Lower body: hip flexion, hip extension, calf raise, leg press, squat) and 30 minutes of treadmill walking. The warm-up and cool down consisted of static stretching. 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 fully supervised by the researchers. Every subject wore a heart rate monitor during the whole training session so as to maintain the correct training intensity.
| Study group | Role | What they receive |
|---|---|---|
| No Exercise (CON) | No intervention | Fifteen obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake was 1921.7 kcal/day. |
| Combined Exercise Training (CET) | Experimental | Fifteen obese adolescent girls. This arm performed combined exercise training 3 times per a week for 12 weeks. Caloric intake was 1921.7 kcal/day. Receives: Behavioral: Combined Exercise Training |
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 baPWV (m/s).
Measured: 12 weeks
Endothelin-1
Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.
Measured: 12 weeks
Insulin resistance
Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
Measured: 12 weeks
Plasma leptin
Plasma leptin was determined by ELISA kit
Measured: 12 weeks
Plasma adiponectin
Plasma adiponectin was measured using ELISA kit
Measured: 12 weeks
Body weight
Body weight 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
Maximal heart rate
Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion.
Measured: 12 weeks
Nitric oxide
Nitric oxide generation was measured by Griess assay kit.
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 posted9 May 2017
- Study start8 Feb 2010
- Primary completion2 May 2011
- Study completion6 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146026
- Sponsor's protocol ID
- PusanNU-2
- Status last verified
- Oct 2020
- First submitted
- 5 May 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong A, Sanchez-Gonzalez MA, Son WM, Kwak YS, Park SY. The Effects of a 12-Week Combined Exercise Training Program on Arterial Stiffness, Vasoactive Substances, Inflammatory Markers, Metabolic Profile, and Body Composition in Obese Adolescent Girls. Pediatr Exerc Sci. 2018 Nov 1;30(4):480-486. doi: 10.1123/pes.2017-0198. Epub 2018 Sep 7.
PubMed 30193554
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 Combined Exercise Training Program on Arterial Stiffness, Endothelial Function, Inflammatory Markers and Metabolic Profile in Obese Adolescent Girls: A Pilot Study.
- ClinicalTrials.gov ID
- NCT03146026
- Acronym / sponsor ID
- PusanNU-2
- Conditions
- Obesity, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- 8 Feb 2010 (actual)
- Primary completion
- 2 May 2011 (actual)
- Study completion
- 6 May 2011 (actual)
- First posted
- 9 May 2017 (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 12 weeks of combined exercise training (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. Thirty obese adolescent girls participated in this study. The girls were randomly divided into CET group (n=15) and control group (n=15). The CET group performed concurrent resistance training followed by aerobic training at 40-70% of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1, C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio 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
| Arm | Type | Receives |
|---|---|---|
| No Exercise (CON) | No intervention | –Fifteen obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake was 1921.7 kcal/day. |
| Combined Exercise Training (CET) | Experimental | Behavioral: Combined Exercise TrainingFifteen obese adolescent girls. This arm performed combined exercise training 3 times per a week for 12 weeks. Caloric intake was 1921.7 kcal/day. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Obese with hyperinsulinemia
- Abdominal obesity
- Sedentary (no regular exercise training or physical activity)
- No weight loss diet during last 6 months.
Key exclusion criteria (3 listed)
- Hypertension
- Pregnancy
- Chronic disease
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 |
|---|---|---|
| Combined Exercise TrainingThe CET program was performed for 60 minutes with 5 minutes of warm-up and cool-down per day, 3 times a week for 12 weeks. Combined exercise consisted of 20 minutes of various resistant band exercises (Upper body: seated rows, biceps curl, shoulder flexion, elbow flexion, chest press; Lower body: hip flexion, hip extension, calf raise, leg press, squat) and 30 minutes of treadmill walking. The warm-up and cool down consisted of static stretching. 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 fully supervised by the researchers. Every subject wore a heart rate monitor during the whole training session so as to maintain the correct training intensity. | Behavioural | Combined Exercise Training (CET) |
Primary outcome
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.
Insulin resistance
Time frame: 12 weeks
Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
Plasma leptin
Time frame: 12 weeks
Plasma leptin was determined by ELISA kit
Plasma adiponectin
Time frame: 12 weeks
Plasma adiponectin was measured using ELISA kit
Body weight
Time frame: 12 weeks
Body weight 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.
Maximal heart rate
Time frame: 12 weeks
Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion.
Nitric oxide
Time frame: 12 weeks
Nitric oxide generation was measured by Griess assay kit.
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.
- Derived from this study: PubMed 30193554Wong A, Sanchez-Gonzalez MA, Son WM, Kwak YS, Park SY. The Effects of a 12-Week Combined Exercise Training Program on Arterial Stiffness, Vasoactive Substances, Inflammatory Markers, Metabolic Profile, and Body Composition in Obese Adolescent Girls. Pediatr Exerc Sci. 2018 Nov 1;30(4):480-486. doi: 10.1123/pes.2017-0198. Epub 2018 Sep 7.
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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 Combined Exercise Training in people with Obesity, Adolescent, 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?
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?
On the ClinicalTrials.gov record for NCT03146026, which also lists 1 linked publication.
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.