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Completed

NCT Number: NCT03146026

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

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.

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Key information

Conditions

Obesity, Adolescent Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

14 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined Exercise Training

Behavioral

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.

Primary outcomes

  1. Arterial stiffness

    Time frame: 12 weeks

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

  2. Endothelin-1

    Time frame: 12 weeks

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

  3. Insulin resistance

    Time frame: 12 weeks

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

  4. Plasma leptin

    Time frame: 12 weeks

    Plasma leptin was determined by ELISA kit

  5. Plasma adiponectin

    Time frame: 12 weeks

    Plasma adiponectin was measured using ELISA kit

  6. Body weight

    Time frame: 12 weeks

    Body weight was measured to nearest 0.1 kg.

  7. Height

    Time frame: 12 weeks

    Height was measured to nearest 1 cm.

  8. 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

  9. Body fat

    Time frame: 12 weeks

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

  10. 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.

  11. Nitric oxide

    Time frame: 12 weeks

    Nitric oxide generation was measured by Griess assay kit.

Sponsors and collaborators

Lead sponsor

Pusan National University

Other

Collaborators

  • University of Nebraska

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 9, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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