Obesity, AdolescentNCT04491019
Comparison of the Effects of Two Different Exercise Programs in Obese Adolescents
A study testing Balance exercise group in people with Obesity, Adolescent, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- Balance exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals aged 12-18 Body Mass Index to be 95 and above according to percentile values No exercise program in the past 6 months
Who cannot join
- Having a medical condition that prevents exercise Having a disease of neuromuscular origin Presence of psychiatric or neurological diseases affecting cooperative and cognitive functions Equilibrium effect due to another disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34740
About this study
Official title: Comparison of the Effects of Two Different Exercise Programs on Balance, Posture and Lower Extremity Functions in Obese Adolescents
Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. In obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. The aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.
- Conditions
- Obesity, Adolescent
- Being tested
- Balance exercise group
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exercise groupOther
Balance exercises will be carried out with a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Balance exercise group | Experimental | Balance exercises will be carried out with a physiotherapist. Receives: Other: Balance exercise group |
| Strengthening exercise group | Experimental | Strengthening exercises will be performed with a physiotherapist. Receives: Other: Balance exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The six-minute walking test
The six-minute walking test is an example of timed distance testing, widely used in clinical research and rehabilitation studies. According to the guidelines published by the American Thoracic Society, 6MWT is an easy-to-use, better tolerated test that reflects daily activities better than other walking tests. It can be applied in a short time. Requires little equipment. The six-minute walk test, used as a field test, is a simple and inexpensive test compatible with daily activities, which does not require exercise equipment. Before starting the test, the patient should rest for at least 10 minutes by sitting in the chair near the starting point. The walking area must be at least 30 m long. A shorter corridor causes more time to be spent for more frequent turns and changes of direction. With the help of stopwatch, it is kept for 6 minutes and the number of laps during the period is calculated and recorded. The functional capacity of the cases will be evaluated with 6MWT.
Measured: Change from baseline to 8 weeks, follow up at two months
Secondary outcomes (8)
Sit Up Stand Test
It reflects the individuals' lower limb muscle strength and functional capacities. For the test, the individual is allowed to sit on the 43.18 cm high chair in the middle of the chair with his back straight, with his feet on the ground and his arms crossed in front of his chest (right hand left shoulder, left hand right shoulder). When the individual is in this position, the test is started with the start command and the number of complete departures that he has made for 30 seconds constitutes the score of the individual. The lower extremity functions of the cases will be evaluated by sit and test.
Measured: Change from baseline to 8 weeks, follow up at two months
Evaluation of Muscle Force
Muscle strength tests are performed to determine the ability to provide strength and stability. One of the methods used in the evaluation of muscle strength is the dynamometer. Compared to isokinetic devices, hand-held dynamometers are considered as a reliable and valid tool for evaluating muscle strength in the clinic due to their easy transportation, cost and small size. The lower extremity muscle strength of the cases will be evaluated with MicroFet 2 brand dynamometer.
Measured: Change from baseline to 8 weeks, follow up at two months
10 Step Down Time Test
All cases are asked to go up to 10 digits (14x28x120 cm) as fast as possible. Step-up time is measured in seconds with a stopwatch. The measurement is repeated three times and the score is recorded by taking the average of the three measurements.
Measured: Change from baseline to 8 weeks, follow up at two months
Functional Forward Reach Test
Functional reach test will be used to evaluate the balance of the cases. The person is asked to stand sideways in a position where the right arm does not touch a tape measure attached to the wall at shoulder height. When the arm is at 90 ° flexion, it is requested to hold the arm in parallel with the tape measure without extending it forward. The distance between the shoulder and the 3rd fingertip is measured. Then, the maximum distance at which he can extend his arm horizontally is measured. The difference between the two positions is calculated in centimeters.
Measured: Change from baseline to 8 weeks, follow up at two months
Flamingo Balance Test
Flamingo Balance Test is used to determine the static balance of the cases. According to this test, the patients stand in balance by standing with the side of the tested side on a wooden balance instrument 50 centimeters long, 4 centimeters high and 3 centimeters wide. He bends his other foot from his knee and holds it with his hand on the same side. While the patient is in balance with one foot in this way, the time begins and tries to stay in balance for 1 minute. The time is stopped when the balance is disturbed (leaving it while holding the foot, falling from the board to the ground, touching the ground with any part of its body, etc.). When the patient goes up to the balance device and restores his balance, the time continues from where he left off. The test continues for a minute. When the time is completed, each patient's attempt to balance (after falling) is counted, and this number is recorded as the patient's score at the end of the test when one minute has been completed.
Measured: Change from baseline to 8 weeks, follow up at two months
One Leg Stand Test
It is a test in which the patient's right and left extremity is measured in balance time and evaluates the static balance. If the patient can stand on one foot for 180 seconds, the test is considered complete. In our study, one foot standing test will be performed in accordance with the criteria specified in the literature. Patients are asked to stand as much as possible on one foot with their eyes open and in a standing position, and the time they are stopped is measured in seconds, measured by a stopwatch. An experiment is made before registration and then the test is repeated 3 times. No oral stimuli are given during the test. The stopwatch is stopped when the patient's foot in the air touches the ground or when the patient loses his standing position (47). Static balance assessment of the cases will be evaluated by standing on one leg test.
Measured: Change from baseline to 8 weeks, follow up at two months
Bioelectrical Impedance Analysis
The method is based on the difference between the lean tissue mass and the electrical permeability of the oil. In the method, weak electrical current impedance is measured. Hand-to-hand, hand-to-foot, foot-to-foot measurements can be made with different BIA analysis tools. Many other data are obtained, such as the amount of body fat, lean body mass, body water, and the distribution of fat in various parts of the body. It is a practical, easy to use and recommended method. The muscle, fat and water ratio of the cases will be evaluated with the InBody Bioelectric Impedance Device.
Measured: Change from baseline to 8 weeks, follow up at two months
PostureScreen Mobile
There are different systems that use digital photographs and software analysis in posture evaluation. PostureScreen Mobile (posture analysis / body composition / motion evaluation software) is a valid and reliable application developed to evaluate posture with the help of a camera system on devices with iOS and Android systems. Posture evaluation is done through the program using the PostureScreen Mobile application. On the front and side photographs of the individual, the specific points determined in the software are marked using the touch screen, and according to these points, the values of the postural disorder and the degree of the disorder are calculated and reported for each patient in "centimeters" by software. Posture evaluation of the cases will be done with PostureScreen Mobile.
Measured: Change from baseline to 8 weeks, follow up at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start27 Feb 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saime Nilay Arman, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491019
- Sponsor's protocol ID
- 02/10/2019-149844
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Two Different Exercise Programs on Balance, Posture and Lower Extremity Functions in Obese Adolescents
- ClinicalTrials.gov ID
- NCT04491019
- Acronym / sponsor ID
- 02/10/2019-149844
- Conditions
- Obesity, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. In obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. The aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance exercise group | Experimental | Other: Balance exercise groupBalance exercises will be carried out with a physiotherapist. |
| Strengthening exercise group | Experimental | Other: Balance exercise groupStrengthening exercises will be performed with a physiotherapist. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Individuals aged 12-18 Body Mass Index to be 95 and above according to percentile values No exercise program in the past 6 months
Key exclusion criteria (1 listed)
- Having a medical condition that prevents exercise Having a disease of neuromuscular origin Presence of psychiatric or neurological diseases affecting cooperative and cognitive functions Equilibrium effect due to another disease
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 |
|---|---|---|
| Balance exercise groupBalance exercises will be carried out with a physiotherapist | Other | Balance exercise group, Strengthening exercise group |
Primary outcome
The six-minute walking test
Time frame: Change from baseline to 8 weeks, follow up at two months
The six-minute walking test is an example of timed distance testing, widely used in clinical research and rehabilitation studies. According to the guidelines published by the American Thoracic Society, 6MWT is an easy-to-use, better tolerated test that reflects daily activities better than other walking tests. It can be applied in a short time. Requires little equipment. The six-minute walk test, used as a field test, is a simple and inexpensive test compatible with daily activities, which does not require exercise equipment. Before starting the test, the patient should rest for at least 10 minutes by sitting in the chair near the starting point. The walking area must be at least 30 m long. A shorter corridor causes more time to be spent for more frequent turns and changes of direction. With the help of stopwatch, it is kept for 6 minutes and the number of laps during the period is calculated and recorded. The functional capacity of the cases will be evaluated with 6MWT.
8 secondary outcomes
Sit Up Stand Test
Time frame: Change from baseline to 8 weeks, follow up at two months
Evaluation of Muscle Force
Time frame: Change from baseline to 8 weeks, follow up at two months
10 Step Down Time Test
Time frame: Change from baseline to 8 weeks, follow up at two months
Functional Forward Reach Test
Time frame: Change from baseline to 8 weeks, follow up at two months
Flamingo Balance Test
Time frame: Change from baseline to 8 weeks, follow up at two months
One Leg Stand Test
Time frame: Change from baseline to 8 weeks, follow up at two months
Bioelectrical Impedance Analysis
Time frame: Change from baseline to 8 weeks, follow up at two months
PostureScreen Mobile
Time frame: Change from baseline to 8 weeks, follow up at two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exercise group in people with Obesity, Adolescent, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
The six-minute walking test (time frame: Change from baseline to 8 weeks, follow up at two months). 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 29 Jul 2020.