Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls

October 30, 2020 updated by: Won-mok son, Pusan National University

Effectiveness of Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obese with Hyperinsulinemia
  • Obese with Abdominal obesity

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height in Meters
Time Frame: 12 weeks
Height was measured before and after 12 weeks.
12 weeks
Weight in Kilograms
Time Frame: 12 weeks
Weight was measured before and after 12 weeks.
12 weeks
BMI in Weight (Kilograms)/Height (Meters)^2
Time Frame: 12 weeks
BMI was calculated with weight and height before and after 12 weeks.
12 weeks
Body Fat in Percents
Time Frame: 12 weeks
Body fat was measured before and after 12 weeks.
12 weeks
Lean Body Mass in Percents
Time Frame: 12 weeks
Lean body mass was measured before and after 12 weeks.
12 weeks
Waist Circumference in Centimeters
Time Frame: 12 weeks
Waist circumference was measured before and after 12 weeks.
12 weeks
Glucose Levels in Millimole Per Liter
Time Frame: 12 weeks
Glucose levels were measured before and after 12 weeks.
12 weeks
Insulin Levels in Micro Unit Per Milliliter
Time Frame: 12 weeks
Insulin levels were measured before and after 12 weeks.
12 weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: 12 weeks
Homeostasis model assessment of Insulin Resistance (HOMA-IR) was calculated before and after 12 weeks
12 weeks
Leptin Levels in Nano Grams Per Milliliter
Time Frame: 12 weeks
Leptin levels were measured before and after 12 weeks.
12 weeks
Adiponectin Levels in Micro Grams Per Milliliter
Time Frame: 12 weeks
Adiponectin levels were measured before and after the training.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volume of Maximal Oxygen Consumption (VO2max)
Time Frame: 12 weeks
Volume of maximal oxygen consumption (VO2max) was determined using a maximal treadmill test before and after 12 weeks.
12 weeks
Arterial Stiffness
Time Frame: 12 weeks
Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.
12 weeks
Systolic Blood Pressure
Time Frame: 12 weeks
Systolic blood pressure was measured before and after 12 weeks.
12 weeks
Diastolic Blood Pressure
Time Frame: 12 weeks
Diastolic blood pressure was measured before and after 12 weeks.
12 weeks
Maximal Heart Rate
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dong-Eui University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNOmaha7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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