ObesityNCT03096873
Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls
A study testing Combined Exercise Training in people with Obesity, run by Pusan National University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Combined Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2011to 5 Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Obese with Hyperinsulinemia
- Obese with Abdominal obesity
Who cannot join
- Hypertension
- Pregnancy
- Chronic diseases
- Weight loss diet within the last 6 months
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Combined Exercise Training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Exercise (CON) | No intervention | Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day |
| Exercise (EX) | Experimental | Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day Receives: Behavioral: Combined Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height in Meters
Height was measured before and after 12 weeks.
Measured: 12 weeks
Weight in Kilograms
Weight was measured before and after 12 weeks.
Measured: 12 weeks
BMI in Weight (Kilograms)/Height (Meters)^2
BMI was calculated with weight and height before and after 12 weeks.
Measured: 12 weeks
Body Fat in Percents
Body fat was measured before and after 12 weeks.
Measured: 12 weeks
Lean Body Mass in Percents
Lean body mass was measured before and after 12 weeks.
Measured: 12 weeks
Waist Circumference in Centimeters
Waist circumference was measured before and after 12 weeks.
Measured: 12 weeks
Glucose Levels in Millimole Per Liter
Glucose levels were measured before and after 12 weeks.
Measured: 12 weeks
Insulin Levels in Micro Unit Per Milliliter
Insulin levels were measured before and after 12 weeks.
Measured: 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
Measured: 12 weeks
Leptin Levels in Nano Grams Per Milliliter
Leptin levels were measured before and after 12 weeks.
Measured: 12 weeks
Adiponectin Levels in Micro Grams Per Milliliter
Adiponectin levels were measured before and after the training.
Measured: 12 weeks
Secondary outcomes (5)
Volume of Maximal Oxygen Consumption (VO2max)
Volume of maximal oxygen consumption (VO2max) was determined using a maximal treadmill test before and after 12 weeks.
Measured: 12 weeks
Arterial Stiffness
Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.
Measured: 12 weeks
Systolic Blood Pressure
Systolic blood pressure was measured before and after 12 weeks.
Measured: 12 weeks
Diastolic Blood Pressure
Diastolic blood pressure was measured before and after 12 weeks.
Measured: 12 weeks
Maximal Heart Rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start3 Mar 2011
- Primary completion3 Jun 2011
- Study completion5 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-Eui University
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096873
- Sponsor's protocol ID
- UNOmaha7
- Status last verified
- Oct 2020
- First submitted
- 17 Mar 2017
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls
- ClinicalTrials.gov ID
- NCT03096873
- Acronym / sponsor ID
- UNOmaha7
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Dong-Eui University
- Study start
- 3 Mar 2011 (actual)
- Primary completion
- 3 Jun 2011 (actual)
- Study completion
- 5 Jun 2011 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Exercise (CON) | No intervention | –Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day |
| Exercise (EX) | Experimental | Behavioral: Combined Exercise TrainingTwenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Obese with Hyperinsulinemia
- Obese with Abdominal obesity
Key exclusion criteria (4 listed)
- Hypertension
- Pregnancy
- Chronic diseases
- Weight loss diet within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Exercise TrainingThe 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. | Behavioural | Exercise (EX) |
Primary outcome
Height in Meters
Time frame: 12 weeks
Height was measured before and after 12 weeks.
Weight in Kilograms
Time frame: 12 weeks
Weight was measured before and after 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.
Body Fat in Percents
Time frame: 12 weeks
Body fat was measured before and after 12 weeks.
Lean Body Mass in Percents
Time frame: 12 weeks
Lean body mass was measured before and after 12 weeks.
Waist Circumference in Centimeters
Time frame: 12 weeks
Waist circumference was measured before and after 12 weeks.
Glucose Levels in Millimole Per Liter
Time frame: 12 weeks
Glucose levels were measured before and after 12 weeks.
Insulin Levels in Micro Unit Per Milliliter
Time frame: 12 weeks
Insulin levels were measured before and after 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
Leptin Levels in Nano Grams Per Milliliter
Time frame: 12 weeks
Leptin levels were measured before and after 12 weeks.
Adiponectin Levels in Micro Grams Per Milliliter
Time frame: 12 weeks
Adiponectin levels were measured before and after the training.
5 secondary outcomes
Volume of Maximal Oxygen Consumption (VO2max)
Time frame: 12 weeks
Arterial Stiffness
Time frame: 12 weeks
Systolic Blood Pressure
Time frame: 12 weeks
Diastolic Blood Pressure
Time frame: 12 weeks
Maximal Heart Rate
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercise Training in people with Obesity, run by Pusan National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height in Meters (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.