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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Adolescent
• Intervention / Treatment: Behavioral: Combined Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

• Hypertension
• Pregnancy
• Chronic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelin-1	Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.	12 weeks
Height	Height was measured to nearest 1 cm.	12 weeks
Arterial stiffness	Arterial stiffness was measured as measurement of baPWV (m/s).	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
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

Collaborators and Investigators

• Sponsor: Pusan National University
• Collaborators: University of Nebraska

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2010
• Primary Completion (Actual): May 2, 2011
• Study Completion (Actual): May 6, 2011

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: PusanNU-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No