Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALCombined 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.
Sponsors
Dong-Eui University
Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Obese with Hyperinsulinemia * Obese with Abdominal obesity
Exclusion criteria
* Hypertension * Pregnancy * Chronic diseases * Weight loss diet within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adiponectin Levels in Micro Grams Per Milliliter | 12 weeks | Adiponectin levels were measured before and after the training. |
| Waist Circumference in Centimeters | 12 weeks | Waist circumference was measured before and after 12 weeks. |
| Glucose Levels in Millimole Per Liter | 12 weeks | Glucose levels were measured before and after 12 weeks. |
| Insulin Levels in Micro Unit Per Milliliter | 12 weeks | Insulin levels were measured before and after 12 weeks. |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 12 weeks | Homeostasis model assessment of Insulin Resistance (HOMA-IR) was calculated before and after 12 weeks |
| Leptin Levels in Nano Grams Per Milliliter | 12 weeks | Leptin levels were measured before and after 12 weeks. |
| Height in Meters | 12 weeks | Height was measured before and after 12 weeks. |
| Weight in Kilograms | 12 weeks | Weight was measured before and after 12 weeks. |
| BMI in Weight (Kilograms)/Height (Meters)^2 | 12 weeks | BMI was calculated with weight and height before and after 12 weeks. |
| Body Fat in Percents | 12 weeks | Body fat was measured before and after 12 weeks. |
| Lean Body Mass in Percents | 12 weeks | Lean body mass was measured before and after 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Stiffness | 12 weeks | Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks. |
| Systolic Blood Pressure | 12 weeks | Systolic blood pressure was measured before and after 12 weeks. |
| Diastolic Blood Pressure | 12 weeks | Diastolic blood pressure was measured before and after 12 weeks. |
| Maximal Heart Rate | 12 weeks | — |
| Volume of Maximal Oxygen Consumption (VO2max) | 12 weeks | Volume of maximal oxygen consumption (VO2max) was determined using a maximal treadmill test before and after 12 weeks. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Exercise (CON) Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day | 20 |
| Exercise (EX) Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day
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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | No Exercise (CON) | Total | Exercise (EX) |
|---|---|---|---|
| Adiponectin | 5.3 ug/mL STANDARD_DEVIATION 0.8 | 5.5 ug/mL STANDARD_DEVIATION 0.7 | 5.7 ug/mL STANDARD_DEVIATION 0.5 |
| Age, Categorical <=18 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14 years STANDARD_DEVIATION 1 | 14 years STANDARD_DEVIATION 1 | 14 years STANDARD_DEVIATION 1 |
| Arterial stiffness | 8.3 m/s STANDARD_DEVIATION 1 | 8.4 m/s STANDARD_DEVIATION 1.1 | 8.5 meters per second (m/s) STANDARD_DEVIATION 1.2 |
| Blood pressure | 122 mmHg STANDARD_DEVIATION 1.2 | 122 mmHg STANDARD_DEVIATION 1.3 | 121 mmHg STANDARD_DEVIATION 1.4 |
| Body mass index | 30 kg/m^2 STANDARD_DEVIATION 1.2 | 30 kg/m^2 STANDARD_DEVIATION 1.7 | 30 kg/m^2 STANDARD_DEVIATION 2.2 |
| Diastolic Blood Pressure | 80 mmHg STANDARD_DEVIATION 2.2 | 80 mmHg STANDARD_DEVIATION 1.8 | 80 mmHg STANDARD_DEVIATION 1.6 |
| Glucose | 5.6 mmol/L STANDARD_DEVIATION 0.2 | 5.6 mmol/L STANDARD_DEVIATION 0.2 | 5.5 mmol/L STANDARD_DEVIATION 0.1 |
| Height | 1.58 meters STANDARD_DEVIATION 0.13 | 1.59 meters STANDARD_DEVIATION 0.07 | 1.6 meters STANDARD_DEVIATION 0.01 |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 6.4 HOMA-IR Score STANDARD_DEVIATION 0.4 | 6.6 HOMA-IR Score STANDARD_DEVIATION 0.5 | 6.7 HOMA-IR Score STANDARD_DEVIATION 0.5 |
| Insulin | 26.2 uU/mL STANDARD_DEVIATION 3.2 | 26.8 uU/mL STANDARD_DEVIATION 2.7 | 27.4 uU/mL STANDARD_DEVIATION 2.2 |
| Lean body mass | 43.7 percent STANDARD_DEVIATION 1.7 | 42.7 percent STANDARD_DEVIATION 1.6 | 41.7 percent STANDARD_DEVIATION 1.4 |
| Leptin | 21.2 ng/mL STANDARD_DEVIATION 2.4 | 21.0 ng/mL STANDARD_DEVIATION 2.3 | 20.8 ng/mL STANDARD_DEVIATION 2.1 |
| Maximal Heart Rate | 202 beats per minute STANDARD_DEVIATION 3 | 203 beats per minute STANDARD_DEVIATION 3 | 203 beats per minute STANDARD_DEVIATION 4 |
| Percentage of body fat | 43.4 percent STANDARD_DEVIATION 2.2 | 43.2 percent STANDARD_DEVIATION 2.2 | 43 percent STANDARD_DEVIATION 2.3 |
| Region of Enrollment South Korea | 20 participants | 40 participants | 20 participants |
| Resting heart rate | 68 beats per minute STANDARD_DEVIATION 3 | 68 beats per minute STANDARD_DEVIATION 3 | 68 beats per minute STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic Blood Pressure | 122 mmHg STANDARD_DEVIATION 1.3 | 121.2 mmHg STANDARD_DEVIATION 1.3 | 121 mmHg STANDARD_DEVIATION 1.4 |
| Volume of maximal oxygen consumption (VO2max) | 25 mL/kg/min of oxygen STANDARD_DEVIATION 2.4 | 25 mL/kg/min of oxygen STANDARD_DEVIATION 2.2 | 25 mL/kg/min of oxygen STANDARD_DEVIATION 1.7 |
| Waist circumference | 87.3 centimeters STANDARD_DEVIATION 1.5 | 87.5 centimeters STANDARD_DEVIATION 1.1 | 87.6 centimeters STANDARD_DEVIATION 0.7 |
| Weight | 75.6 kilograms STANDARD_DEVIATION 2.8 | 76 kilograms STANDARD_DEVIATION 2.8 | 76.4 kilograms STANDARD_DEVIATION 2.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Adiponectin Levels in Micro Grams Per Milliliter
Adiponectin levels were measured before and after the training.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Adiponectin Levels in Micro Grams Per Milliliter | 5.7 ug/mL | Standard Deviation 0.5 |
| Exercise (EX) | Adiponectin Levels in Micro Grams Per Milliliter | 8.5 ug/mL | Standard Deviation 0.1 |
Primary
BMI in Weight (Kilograms)/Height (Meters)^2
BMI was calculated with weight and height before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | BMI in Weight (Kilograms)/Height (Meters)^2 | 30 kilograms per meter squared (kg/m^2) | Standard Deviation 1.4 |
| Exercise (EX) | BMI in Weight (Kilograms)/Height (Meters)^2 | 27 kilograms per meter squared (kg/m^2) | Standard Deviation 2.1 |
Primary
Body Fat in Percents
Body fat was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Body Fat in Percents | 43 percent | Standard Deviation 2.2 |
| Exercise (EX) | Body Fat in Percents | 39.6 percent | Standard Deviation 2.1 |
Primary
Glucose Levels in Millimole Per Liter
Glucose levels were measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Glucose Levels in Millimole Per Liter | 5.4 mmol/L | Standard Deviation 0.1 |
| Exercise (EX) | Glucose Levels in Millimole Per Liter | 4.3 mmol/L | Standard Deviation 0.2 |
Primary
Height in Meters
Height was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Height in Meters | 1.58 meters | Standard Deviation 0.15 |
| Exercise (EX) | Height in Meters | 1.60 meters | Standard Deviation 0.11 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 6.5 HOMA-IR Score | Standard Deviation 0.6 |
| Exercise (EX) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 1.9 HOMA-IR Score | Standard Deviation 0.7 |
Primary
Insulin Levels in Micro Unit Per Milliliter
Insulin levels were measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Insulin Levels in Micro Unit Per Milliliter | 27 uU/mL | Standard Deviation 2.4 |
| Exercise (EX) | Insulin Levels in Micro Unit Per Milliliter | 10.3 uU/mL | Standard Deviation 2.1 |
Primary
Lean Body Mass in Percents
Lean body mass was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Lean Body Mass in Percents | 43 percent | Standard Deviation 2.2 |
| Exercise (EX) | Lean Body Mass in Percents | 39.6 percent | Standard Deviation 2.1 |
Primary
Leptin Levels in Nano Grams Per Milliliter
Leptin levels were measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Leptin Levels in Nano Grams Per Milliliter | 22.5 ng/mL | Standard Deviation 2.3 |
| Exercise (EX) | Leptin Levels in Nano Grams Per Milliliter | 12.8 ng/mL | Standard Deviation 1.4 |
Primary
Waist Circumference in Centimeters
Waist circumference was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Waist Circumference in Centimeters | 88.2 centimeters (cm) | Standard Deviation 1 |
| Exercise (EX) | Waist Circumference in Centimeters | 83.5 centimeters (cm) | Standard Deviation 0.5 |
Primary
Weight in Kilograms
Weight was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Weight in Kilograms | 75.8 kilograms (kg) | Standard Deviation 1.5 |
| Exercise (EX) | Weight in Kilograms | 70.2 kilograms (kg) | Standard Deviation 2.9 |
Secondary
Arterial Stiffness
Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Arterial Stiffness | 8.4 meters per second (m/s) | Standard Deviation 1 |
| Exercise (EX) | Arterial Stiffness | 8.4 meters per second (m/s) | Standard Deviation 1 |
Secondary
Diastolic Blood Pressure
Diastolic blood pressure was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Diastolic Blood Pressure | 80 mmHg | Standard Deviation 2.4 |
| Exercise (EX) | Diastolic Blood Pressure | 78 mmHg | Standard Deviation 1.55 |
Secondary
Maximal Heart Rate
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Maximal Heart Rate | 202 beats per minute | Standard Deviation 4 |
| Exercise (EX) | Maximal Heart Rate | 202 beats per minute | Standard Deviation 3 |
Secondary
Systolic Blood Pressure
Systolic blood pressure was measured before and after 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Systolic Blood Pressure | 124 mmHg | Standard Deviation 1.4 |
| Exercise (EX) | Systolic Blood Pressure | 120 mmHg | Standard Deviation 0.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Exercise (CON) | Volume of Maximal Oxygen Consumption (VO2max) | 26 mL/kg/min of oxygen | Standard Deviation 2.1 |
| Exercise (EX) | Volume of Maximal Oxygen Consumption (VO2max) | 27 mL/kg/min of oxygen | Standard Deviation 1.2 |