An interventional study of Combined Exercise Training in Obesity, sponsored by Pusan National University. Completed. Open to female participants aged 14 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Pusan National University · Not applicable, Interventional, and Health services research
The purpose of the study was to observe therapeutic effects of combined resistance and aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese adolescent girls (14±1 years) participated in this study. The participants were randomly separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise group performed 12 weeks of CRAE.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
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Exclusion Criteria:
Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day
Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day
Behavioral: Combined Exercise Training
The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks.
Height in Meters
Height was measured before and after 12 weeks.
Time frame: 12 weeks
Weight in Kilograms
Weight was measured before and after 12 weeks.
Time frame: 12 weeks
BMI in Weight (Kilograms)/Height (Meters)^2
BMI was calculated with weight and height before and after 12 weeks.
Time frame: 12 weeks
Body Fat in Percents
Body fat was measured before and after 12 weeks.
Time frame: 12 weeks
Lean Body Mass in Percents
Lean body mass was measured before and after 12 weeks.
Time frame: 12 weeks
Waist Circumference in Centimeters
Waist circumference was measured before and after 12 weeks.
Time frame: 12 weeks
Glucose Levels in Millimole Per Liter
Glucose levels were measured before and after 12 weeks.
Time frame: 12 weeks
Insulin Levels in Micro Unit Per Milliliter
Insulin levels were measured before and after 12 weeks.
Time frame: 12 weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Homeostasis model assessment of Insulin Resistance (HOMA-IR) was calculated before and after 12 weeks
Time frame: 12 weeks
Leptin Levels in Nano Grams Per Milliliter
Leptin levels were measured before and after 12 weeks.
Time frame: 12 weeks
Adiponectin Levels in Micro Grams Per Milliliter
Adiponectin levels were measured before and after the training.
Time frame: 12 weeks
Volume of Maximal Oxygen Consumption (VO2max)
Volume of maximal oxygen consumption (VO2max) was determined using a maximal treadmill test before and after 12 weeks.
Time frame: 12 weeks
Arterial Stiffness
Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.
Time frame: 12 weeks
Systolic Blood Pressure
Systolic blood pressure was measured before and after 12 weeks.
Time frame: 12 weeks
Diastolic Blood Pressure
Diastolic blood pressure was measured before and after 12 weeks.
Time frame: 12 weeks
Maximal Heart Rate
Time frame: 12 weeks
| Milestone | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Height was measured before and after 12 weeks.
| meters | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Height in Meters | 1.58 ± 0.15 | 1.60 ± 0.11 |
Weight was measured before and after 12 weeks.
| kilograms (kg) | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Weight in Kilograms | 75.8 ± 1.5 | 70.2 ± 2.9 |
BMI was calculated with weight and height before and after 12 weeks.
| kilograms per meter squared (kg/m^2) | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| BMI in Weight (Kilograms)/Height (Meters)^2 | 30 ± 1.4 | 27 ± 2.1 |
Body fat was measured before and after 12 weeks.
| percent | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Body Fat in Percents | 43 ± 2.2 | 39.6 ± 2.1 |
Lean body mass was measured before and after 12 weeks.
| percent | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Lean Body Mass in Percents | 43 ± 2.2 | 39.6 ± 2.1 |
Waist circumference was measured before and after 12 weeks.
| centimeters (cm) | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Waist Circumference in Centimeters | 88.2 ± 1.0 | 83.5 ± 0.5 |
Glucose levels were measured before and after 12 weeks.
| mmol/L | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Glucose Levels in Millimole Per Liter | 5.4 ± 0.1 | 4.3 ± 0.2 |
Insulin levels were measured before and after 12 weeks.
| uU/mL | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Insulin Levels in Micro Unit Per Milliliter | 27 ± 2.4 | 10.3 ± 2.1 |
Homeostasis model assessment of Insulin Resistance (HOMA-IR) was calculated before and after 12 weeks
| HOMA-IR Score | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 6.5 ± 0.6 | 1.9 ± 0.7 |
Leptin levels were measured before and after 12 weeks.
| ng/mL | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Leptin Levels in Nano Grams Per Milliliter | 22.5 ± 2.3 | 12.8 ± 1.4 |
Adiponectin levels were measured before and after the training.
| ug/mL | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Adiponectin Levels in Micro Grams Per Milliliter | 5.7 ± 0.5 | 8.5 ± 0.1 |
Volume of maximal oxygen consumption (VO2max) was determined using a maximal treadmill test before and after 12 weeks.
| mL/kg/min of oxygen | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Volume of Maximal Oxygen Consumption (VO2max) | 26 ± 2.1 | 27 ± 1.2 |
Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.
| meters per second (m/s) | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Arterial Stiffness | 8.4 ± 1 | 8.4 ± 1 |
Systolic blood pressure was measured before and after 12 weeks.
| mmHg | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Systolic Blood Pressure | 124 ± 1.4 | 120 ± 0.4 |
Diastolic blood pressure was measured before and after 12 weeks.
| mmHg | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Diastolic Blood Pressure | 80 ± 2.4 | 78 ± 1.55 |
| beats per minute | No Exercise (CON) | Exercise (EX) |
|---|---|---|
| Maximal Heart Rate | 202 ± 4 | 202 ± 3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Exercise (CON) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Exercise (EX) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| <=18 years | 20 | 20 | 40 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| Mean | 14 ± 1 | 14 ± 1 | 14 ± 1 |
| Sex: Female, Male(Participants) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| South Korea | 20 | 20 | 40 |
| Weight(kilograms) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| Mean | 75.6 ± 2.8 | 76.4 ± 2.8 | 76 ± 2.8 |
| Waist circumference(centimeters) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| Mean | 87.3 ± 1.5 | 87.6 ± 0.7 | 87.5 ± 1.1 |
| Percentage of body fat(percent) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| Mean | 43.4 ± 2.2 | 43 ± 2.3 | 43.2 ± 2.2 |
| Glucose(mmol/L) | No Exercise (CON) | Exercise (EX) | Total |
|---|---|---|---|
| Mean | 5.6 ± 0.2 | 5.5 ± 0.1 | 5.6 ± 0.2 |
15 further baseline measures are reported on the registry.
No study locations are listed for this record.
Ran from Mar 2011 to primary completion in Jun 2011, 3 months.
Results were first posted in Aug 2019, 8 years 2 months after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Pusan National University