CClinicalTrials.gg
CompletedNCT03146026Updated Nov 3, 2020

The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.

An interventional study of Combined Exercise Training in Obesity, Adolescent, sponsored by Pusan National University. Completed. Open to female participants aged 14 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by Pusan National University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
14 Years to 16 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Obesity, Adolescent

Browse trials for

03

Who can participate

Ages eligible
14 Years to 16 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Obese with hyperinsulinemia
  • Abdominal obesity
  • Sedentary (no regular exercise training or physical activity)
  • No weight loss diet during last 6 months.

Exclusion criteria

Exclusion Criteria:

  • Hypertension
  • Pregnancy
  • Chronic disease
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    No Exercise (CON)

    Fifteen obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake was 1921.7 kcal/day.

  • Experimental
    Combined Exercise Training (CET)

    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.

    Behavioral: Combined Exercise Training

Interventions

  • BehavioralCombined Exercise Training

    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.

05

What researchers measure

Primary outcomes

  1. Arterial stiffness

    Arterial stiffness was measured as measurement of baPWV (m/s).

    Time frame: 12 weeks

  2. Endothelin-1

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

    Time frame: 12 weeks

  3. Insulin resistance

    Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).

    Time frame: 12 weeks

  4. Plasma leptin

    Plasma leptin was determined by ELISA kit

    Time frame: 12 weeks

  5. Plasma adiponectin

    Plasma adiponectin was measured using ELISA kit

    Time frame: 12 weeks

  6. Body weight

    Body weight was measured to nearest 0.1 kg.

    Time frame: 12 weeks

  7. Height

    Height was measured to nearest 1 cm.

    Time frame: 12 weeks

  8. 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

    Time frame: 12 weeks

  9. Body fat

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

    Time frame: 12 weeks

  10. Maximal heart rate

    Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion.

    Time frame: 12 weeks

  11. Nitric oxide

    Nitric oxide generation was measured by Griess assay kit.

    Time frame: 12 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

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. Erratum In: Pediatr Exerc Sci. 2020 Aug 1;32(3):183. doi: 10.1123/pes.2020-0095. PubMed 30193554 ↗
08

Registry details

Key details

Study ID
NCT03146026
Lead sponsor
Pusan National University
Collaborators
University of Nebraska
Responsible party
Won-mok son (Principal Investigator, Pusan National University) — Principal investigator
First posted
May 9, 2017
Start date
Feb 8, 2010
Primary completion
May 2, 2011
Completion
May 6, 2011
Last update
Nov 3, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion