- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096873
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
Study Type
Interventional
Enrollment (Actual)
40
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
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
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
Collaborators
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)
March 3, 2011
Primary Completion (Actual)
June 3, 2011
Study Completion (Actual)
June 5, 2011
Study Registration Dates
First Submitted
March 17, 2017
First Submitted That Met QC Criteria
March 24, 2017
First Posted (Actual)
March 30, 2017
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Combined Exercise Training
-
Associacao de Investigacao de Cuidados de Suporte...Universidad Europea de Madrid; Centro Hospitalar de Vila Nova de Gaia/Espinho; University Institute of MaiaCompletedBreast CancerPortugal
-
Federal University of UberlandiaCompletedMenopause | Exercise | Blood Pressure, HighBrazil
-
Ankara Yildirim Beyazıt UniversityCompletedPhysical TherapyTurkey
-
Gazi UniversityCompleted
-
University of AthensUnknown
-
Riphah International UniversityCompletedHypertension | ObesePakistan
-
Gazi UniversityActive, not recruiting
-
University of BarcelonaUniversity of Pittsburgh; Germans Trias i Pujol Hospital; Ministerio de Economía... and other collaboratorsCompletedAging | Cognitive Function 1, SocialSpain
-
Bezmialem Vakif UniversityUnknownMultiple Sclerosis, Relapsing-Remitting
-
University of Trás-os-Montes and Alto DouroCompletedLipid Metabolism Disorders | Sarcopenia | Osteoporosis | Overweight and Obesity | Personal Satisfaction | Hypertension With Complications and Secondary HypertensionPortugal