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

Sponsor
Pusan National University (Other)
Overall Status
Completed
CT.gov ID
NCT03146026
Collaborator
University of Nebraska (Other)
30
2
14.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Combined Exercise Training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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.
Actual Study Start Date :
Feb 8, 2010
Actual Primary Completion Date :
May 2, 2011
Actual Study Completion Date :
May 6, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Arterial stiffness [12 weeks]

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

  2. Endothelin-1 [12 weeks]

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

  3. Insulin resistance [12 weeks]

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

  4. Plasma leptin [12 weeks]

    Plasma leptin was determined by ELISA kit

  5. Plasma adiponectin [12 weeks]

    Plasma adiponectin was measured using ELISA kit

  6. Body weight [12 weeks]

    Body weight was measured to nearest 0.1 kg.

  7. Height [12 weeks]

    Height was measured to nearest 1 cm.

  8. Waist circumference [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 [12 weeks]

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

  10. Maximal heart rate [12 weeks]

    Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion.

  11. Nitric oxide [12 weeks]

    Nitric oxide generation was measured by Griess assay kit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 16 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pusan National University
  • University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Won-mok son, Principal Investigator, Pusan National University
ClinicalTrials.gov Identifier:
NCT03146026
Other Study ID Numbers:
  • PusanNU-2
First Posted:
May 9, 2017
Last Update Posted:
Nov 3, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2020