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
About this trial
This is an interventional health services research trial for Obesity, Adolescent
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
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
NCT ID
NCT03146026
First Posted
May 5, 2017
Last Updated
October 30, 2020
Sponsor
Pusan National University
Collaborators
University of Nebraska
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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