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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03146026
Other study ID # PusanNU-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2010
Est. completion date May 6, 2011

Study information

Verified date October 2020
Source Pusan National University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 6, 2011
Est. primary completion date May 2, 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Pusan National University University of Nebraska

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial stiffness Arterial stiffness was measured as measurement of baPWV (m/s). 12 weeks
Primary Endothelin-1 Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit. 12 weeks
Primary Insulin resistance Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR). 12 weeks
Primary Plasma leptin Plasma leptin was determined by ELISA kit 12 weeks
Primary Plasma adiponectin Plasma adiponectin was measured using ELISA kit 12 weeks
Primary Body weight Body weight was measured to nearest 0.1 kg. 12 weeks
Primary Height Height was measured to nearest 1 cm. 12 weeks
Primary 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
Primary Body fat Percent body fat (%) was determined using a bioelectrical impedance-meter. 12 weeks
Primary Maximal heart rate Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion. 12 weeks
Primary Nitric oxide Nitric oxide generation was measured by Griess assay kit. 12 weeks
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