NCT03146026

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2011

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2011

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

May 5, 2017

Last Update Submit

October 30, 2020

Conditions

Obesity, Adolescent

Outcome Measures

Primary Outcomes (11)

  • Arterial stiffness

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

    12 weeks

  • Endothelin-1

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

    12 weeks

  • Insulin resistance

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

    12 weeks

  • Plasma leptin

    Plasma leptin was determined by ELISA kit

    12 weeks

  • Plasma adiponectin

    Plasma adiponectin was measured using ELISA kit

    12 weeks

  • Body weight

    Body weight 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

  • Maximal heart rate

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

    12 weeks

  • Nitric oxide

    Nitric oxide generation was measured by Griess assay kit.

    12 weeks

Study Arms (2)

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.

Behavioral: Combined Exercise Training

Interventions

Combined Exercise TrainingBEHAVIORAL

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.

Combined Exercise Training (CET)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Hypertension
  • Pregnancy
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30193554DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 9, 2017

Study Start

February 8, 2010

Primary Completion

May 2, 2011

Study Completion

May 6, 2011

Last Updated

November 3, 2020

Record last verified: 2020-10