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

Primary Purpose

Obesity, Adolescent

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined Exercise Training
Sponsored by
Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity, Adolescent

Eligibility Criteria

14 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    No Exercise (CON)

    Combined Exercise Training (CET)

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2017
    Last Updated
    October 30, 2020
    Sponsor
    Pusan National University
    Collaborators
    University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03146026
    Brief Title
    The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.
    Official 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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 8, 2010 (Actual)
    Primary Completion Date
    May 2, 2011 (Actual)
    Study Completion Date
    May 6, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University
    Collaborators
    University of Nebraska

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Adolescent

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No Exercise (CON)
    Arm Type
    No Intervention
    Arm Description
    Fifteen obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake was 1921.7 kcal/day.
    Arm Title
    Combined Exercise Training (CET)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Combined Exercise Training
    Intervention Description
    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 Outcome Measure Information:
    Title
    Arterial stiffness
    Description
    Arterial stiffness was measured as measurement of baPWV (m/s).
    Time Frame
    12 weeks
    Title
    Endothelin-1
    Description
    Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.
    Time Frame
    12 weeks
    Title
    Insulin resistance
    Description
    Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
    Time Frame
    12 weeks
    Title
    Plasma leptin
    Description
    Plasma leptin was determined by ELISA kit
    Time Frame
    12 weeks
    Title
    Plasma adiponectin
    Description
    Plasma adiponectin was measured using ELISA kit
    Time Frame
    12 weeks
    Title
    Body weight
    Description
    Body weight was measured to nearest 0.1 kg.
    Time Frame
    12 weeks
    Title
    Height
    Description
    Height was measured to nearest 1 cm.
    Time Frame
    12 weeks
    Title
    Waist circumference
    Description
    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
    Title
    Body fat
    Description
    Percent body fat (%) was determined using a bioelectrical impedance-meter.
    Time Frame
    12 weeks
    Title
    Maximal heart rate
    Description
    Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion.
    Time Frame
    12 weeks
    Title
    Nitric oxide
    Description
    Nitric oxide generation was measured by Griess assay kit.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30193554
    Citation
    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.
    Results Reference
    derived

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

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