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CompletedNCT03096873Updated Nov 3, 2020Results posted

Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
14 Years to 16 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obesity

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03

Who can participate

Ages eligible
14 Years to 16 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Obese with Hyperinsulinemia
  • Obese with Abdominal obesity

Exclusion criteria

Exclusion Criteria:

  • Hypertension
  • Pregnancy
  • Chronic diseases
  • Weight loss diet within the last 6 months
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    No Exercise (CON)

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

  • Experimental
    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

    Behavioral: Combined Exercise Training

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.

05

What researchers measure

Primary outcomes

  1. Height in Meters

    Height was measured before and after 12 weeks.

    Time frame: 12 weeks

  2. Weight in Kilograms

    Weight was measured before and after 12 weeks.

    Time frame: 12 weeks

  3. BMI in Weight (Kilograms)/Height (Meters)^2

    BMI was calculated with weight and height before and after 12 weeks.

    Time frame: 12 weeks

  4. Body Fat in Percents

    Body fat was measured before and after 12 weeks.

    Time frame: 12 weeks

  5. Lean Body Mass in Percents

    Lean body mass was measured before and after 12 weeks.

    Time frame: 12 weeks

  6. Waist Circumference in Centimeters

    Waist circumference was measured before and after 12 weeks.

    Time frame: 12 weeks

  7. Glucose Levels in Millimole Per Liter

    Glucose levels were measured before and after 12 weeks.

    Time frame: 12 weeks

  8. Insulin Levels in Micro Unit Per Milliliter

    Insulin levels were measured before and after 12 weeks.

    Time frame: 12 weeks

  9. 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

  10. Leptin Levels in Nano Grams Per Milliliter

    Leptin levels were measured before and after 12 weeks.

    Time frame: 12 weeks

  11. Adiponectin Levels in Micro Grams Per Milliliter

    Adiponectin levels were measured before and after the training.

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. Arterial Stiffness

    Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.

    Time frame: 12 weeks

  3. Systolic Blood Pressure

    Systolic blood pressure was measured before and after 12 weeks.

    Time frame: 12 weeks

  4. Diastolic Blood Pressure

    Diastolic blood pressure was measured before and after 12 weeks.

    Time frame: 12 weeks

  5. Maximal Heart Rate

    Time frame: 12 weeks

06

Results

Posted Aug 19, 2019

Participant flow

Participant flow — Overall Study
MilestoneNo Exercise (CON)Exercise (EX)
Started2020
Completed2020
Not completed00

Outcome measures

PrimaryHeight in Meters

Height was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · meters
Height in Meters
metersNo Exercise (CON)Exercise (EX)
Height in Meters1.58 ± 0.151.60 ± 0.11
PrimaryWeight in Kilograms

Weight was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · kilograms (kg)
Weight in Kilograms
kilograms (kg)No Exercise (CON)Exercise (EX)
Weight in Kilograms75.8 ± 1.570.2 ± 2.9
PrimaryBMI in Weight (Kilograms)/Height (Meters)^2

BMI was calculated with weight and height before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · kilograms per meter squared (kg/m^2)
BMI in Weight (Kilograms)/Height (Meters)^2
kilograms per meter squared (kg/m^2)No Exercise (CON)Exercise (EX)
BMI in Weight (Kilograms)/Height (Meters)^230 ± 1.427 ± 2.1
PrimaryBody Fat in Percents

Body fat was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · percent
Body Fat in Percents
percentNo Exercise (CON)Exercise (EX)
Body Fat in Percents43 ± 2.239.6 ± 2.1
PrimaryLean Body Mass in Percents

Lean body mass was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · percent
Lean Body Mass in Percents
percentNo Exercise (CON)Exercise (EX)
Lean Body Mass in Percents43 ± 2.239.6 ± 2.1
PrimaryWaist Circumference in Centimeters

Waist circumference was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · centimeters (cm)
Waist Circumference in Centimeters
centimeters (cm)No Exercise (CON)Exercise (EX)
Waist Circumference in Centimeters88.2 ± 1.083.5 ± 0.5
PrimaryGlucose Levels in Millimole Per Liter

Glucose levels were measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · mmol/L
Glucose Levels in Millimole Per Liter
mmol/LNo Exercise (CON)Exercise (EX)
Glucose Levels in Millimole Per Liter5.4 ± 0.14.3 ± 0.2
PrimaryInsulin Levels in Micro Unit Per Milliliter

Insulin levels were measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · uU/mL
Insulin Levels in Micro Unit Per Milliliter
uU/mLNo Exercise (CON)Exercise (EX)
Insulin Levels in Micro Unit Per Milliliter27 ± 2.410.3 ± 2.1
PrimaryHomeostasis 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
Reported as:
Mean · HOMA-IR Score
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR ScoreNo Exercise (CON)Exercise (EX)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)6.5 ± 0.61.9 ± 0.7
PrimaryLeptin Levels in Nano Grams Per Milliliter

Leptin levels were measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · ng/mL
Leptin Levels in Nano Grams Per Milliliter
ng/mLNo Exercise (CON)Exercise (EX)
Leptin Levels in Nano Grams Per Milliliter22.5 ± 2.312.8 ± 1.4
PrimaryAdiponectin Levels in Micro Grams Per Milliliter

Adiponectin levels were measured before and after the training.

Time frame:
12 weeks
Reported as:
Mean · ug/mL
Adiponectin Levels in Micro Grams Per Milliliter
ug/mLNo Exercise (CON)Exercise (EX)
Adiponectin Levels in Micro Grams Per Milliliter5.7 ± 0.58.5 ± 0.1
SecondaryVolume 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
Reported as:
Mean · mL/kg/min of oxygen
Volume of Maximal Oxygen Consumption (VO2max)
mL/kg/min of oxygenNo Exercise (CON)Exercise (EX)
Volume of Maximal Oxygen Consumption (VO2max)26 ± 2.127 ± 1.2
SecondaryArterial Stiffness

Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · meters per second (m/s)
Arterial Stiffness
meters per second (m/s)No Exercise (CON)Exercise (EX)
Arterial Stiffness8.4 ± 18.4 ± 1
SecondarySystolic Blood Pressure

Systolic blood pressure was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · mmHg
Systolic Blood Pressure
mmHgNo Exercise (CON)Exercise (EX)
Systolic Blood Pressure124 ± 1.4120 ± 0.4
SecondaryDiastolic Blood Pressure

Diastolic blood pressure was measured before and after 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · mmHg
Diastolic Blood Pressure
mmHgNo Exercise (CON)Exercise (EX)
Diastolic Blood Pressure80 ± 2.478 ± 1.55
SecondaryMaximal Heart Rate
Time frame:
12 weeks
Reported as:
Mean · beats per minute
Maximal Heart Rate
beats per minuteNo Exercise (CON)Exercise (EX)
Maximal Heart Rate202 ± 4202 ± 3

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
No Exercise (CON)0/20 (0%)0/20 (0%)0/20 (0%)
Exercise (EX)0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)No Exercise (CON)Exercise (EX)Total
<=18 years202040
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)No Exercise (CON)Exercise (EX)Total
Mean14 ± 114 ± 114 ± 1
Sex: Female, Male
Sex: Female, Male(Participants)No Exercise (CON)Exercise (EX)Total
Female202040
Male000
Region of Enrollment
Region of Enrollment(participants)No Exercise (CON)Exercise (EX)Total
South Korea202040
Weight
Weight(kilograms)No Exercise (CON)Exercise (EX)Total
Mean75.6 ± 2.876.4 ± 2.876 ± 2.8
Waist circumference
Waist circumference(centimeters)No Exercise (CON)Exercise (EX)Total
Mean87.3 ± 1.587.6 ± 0.787.5 ± 1.1
Percentage of body fat
Percentage of body fat(percent)No Exercise (CON)Exercise (EX)Total
Mean43.4 ± 2.243 ± 2.343.2 ± 2.2
Glucose
Glucose(mmol/L)No Exercise (CON)Exercise (EX)Total
Mean5.6 ± 0.25.5 ± 0.15.6 ± 0.2

15 further baseline measures are reported on the registry.

07

Study locations

No study locations are listed for this record.

08

Registry details

Key details

Study ID
NCT03096873
Lead sponsor
Pusan National University
Collaborators
Dong-Eui University
Responsible party
Won-mok son (Principal Investigator, Pusan National University) — Principal investigator
First posted
Mar 30, 2017
Start date
Mar 3, 2011
Primary completion
Jun 3, 2011
Completion
Jun 5, 2011
Results posted
Aug 19, 2019
Last update
Nov 3, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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