Childhood ObesityNCT04284670
The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children
A study testing EXERCISE in people with Childhood Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- EXERCISE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Feb 2020to 1 Nov 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescents aged 5-18.
- Children and adolescents with overweight defined as BMI percentile over 85%.
- Children and adolescents who are able to perform moderate physical activity.
- Children and adolescents that participate in 'Meir' hospital sports and health centre.
Who cannot join
- Participant that does not wish to participate - will not be obligated to do so, and shall not participate in the study.
- Participants with orthopaedic history in the past two years.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
'Meir children's sport and health center'
Kfar Saba, 44281
Dan Nemet, MD, 972-9-7471076, dan.nemet@clalit.org.il
Dan Nemet, MD
About this study
The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children.
Read the detailed description
recent studies have shown that similarly to regular exercise, aerobic ECcentric Contraction (ECC) exercise induces changes in the musculoskeletal system while using lower energy consumption, due to the fact that eccentric training creates greater force in the muscle.
most of the studies in this subject were done on healthy or overweight adults. therefore, the effect of aerobic eccentric training on children is still unknown. this study wants to test the impact of eccentric training on overweight and obese children.
this study will include approximately 100 overweight and obese children (boys and girls), aged 5-18 years. participants will be recruited from the population of overweight children from children sports medical center 'Meir' in Kfar Saba, Israel. participants will be randomly divided into two groups (intervention and control). Participants and their parents will sign a consent form before entering the study.
Each participant will undergo a series of tests including: anthropometrics (height, weight, bmi, body composition by BIA), fitness tests (Maximal distance achieved in a 12min outdoor run\walk, Vertical jump, Standing long jump, 4X10 meter sprint run), quadriceps and hamstrings strength test (hand-held dynamometer MicroFet2), bone strength (bone sonometer), ankle and tibial kinematic(accelerometers+ video of foot strike).
Intervention group will then perform an 8 week (16 sessions) ECC training program on a decline treadmill, the program will include two weeks of habituation to lower as possible DOMS (delayed onset muscle soreness) and possible injuries, training length and intensity will be gradually increasing over the time of the program, maximal negative gradient will be -15% at the end of the program.
Control group will perform the same amount of training (volume, intensity and frequency) on a neutral gradient surface. After completing the training program each participant will perform again the series of tests. Once all the data is collected, statistical test will be performed in order to learn about the effect of ECC training program on overweight and obese children.
- Conditions
- Childhood Obesity
- Being tested
- EXERCISE
- Keywords
- eccentric training, childhood obesity, decline treadmill
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISEOther
The intervention group will perform an 8 week program, 2 sessions a weak for a total of 16 sessions. training will be done on a designated negative gradient treadmill, first two session will be in -5% gradient. sessions 3,4 and 5 will be in -10% gradient, all of the following sessions will be in -15% gradient. exercise intensity will be 70%-80% out of maximal heart-rate. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. each training will start and end with a 2 minutes of warm up and calm down under neutral gradient. Every two minutes of training, Visual Analog Scale and Rating of Perceived Exertion data will be collected from the participants.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric treadmill training | Experimental | The intervention group will perform an 8 week program, 2 sessions a week for a total of 16 sessions. training will be done on a designated negative gradient treadmill. first two session will be in -5% gradient. sessions 3,4 and 5 will be in -10% gradient, all of the following sessions will be in -15% gradient. exercise intensity will be 70%-80% out of maximal heart-rate. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. each training will start and end with a 2 minutes of warm up and calm down under neutral gradient. Every two minutes of training, Visual Analog Scale and Rating of Perceived Exertion data will be collected from the participants. Receives: Other: EXERCISE |
| Control group | Experimental | The control group will receive the same amount of training under neutral gradient surface(0%).The program will be 8 weeks while in each week there will be two exercise sessions and a total of 16 sessions. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. Training intensity will be 70%-80% out of maximal heart-rate. Receives: Other: EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness
participants will show changes in physical activity-run/walk perseverance time.
Measured: 8 weeks
BMI Percentile
participants will show changes in BMI Percentile
Measured: 8 weeks
Muscle strength by Hand-held Dynamometer(newton)
participants will show changes in quadriceps and hamstring group muscles strength.
Measured: 8 weeks
Tibial Bone Strength by US(m/s)
participants will show changes in tibial bone strength
Measured: 8 weeks
Peak Positive Acceleration (PPA)
participants will show changes in tibial bone acceleration.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start20 Feb 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Nemet, MD, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284670
- Sponsor's protocol ID
- MeirMc0163-19CTIL
- Status last verified
- Feb 2020
- First submitted
- 25 Sep 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children
- ClinicalTrials.gov ID
- NCT04284670
- Acronym / sponsor ID
- MeirMc0163-19CTIL
- Conditions
- Childhood Obesity
- Keywords
- eccentric training, childhood obesity, decline treadmill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 26 Feb 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.
The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children.
Detailed description
recent studies have shown that similarly to regular exercise, aerobic ECcentric Contraction (ECC) exercise induces changes in the musculoskeletal system while using lower energy consumption, due to the fact that eccentric training creates greater force in the muscle.
most of the studies in this subject were done on healthy or overweight adults. therefore, the effect of aerobic eccentric training on children is still unknown. this study wants to test the impact of eccentric training on overweight and obese children.
this study will include approximately 100 overweight and obese children (boys and girls), aged 5-18 years. participants will be recruited from the population of overweight children from children sports medical center 'Meir' in Kfar Saba, Israel. participants will be randomly divided into two groups (intervention and control). Participants and their parents will sign a consent form before entering the study.
Each participant will undergo a series of tests including: anthropometrics (height, weight, bmi, body composition by BIA), fitness tests (Maximal distance achieved in a 12min outdoor run\walk, Vertical jump, Standing long jump, 4X10 meter sprint run), quadriceps and hamstrings strength test (hand-held dynamometer MicroFet2), bone strength (bone sonometer), ankle and tibial kinematic(accelerometers+ video of foot strike).
Intervention group will then perform an 8 week (16 sessions) ECC training program on a decline treadmill, the program will include two weeks of habituation to lower as possible DOMS (delayed onset muscle soreness) and possible injuries, training length and intensity will be gradually increasing over the time of the program, maximal negative gradient will be -15% at the end of the program.
Control group will perform the same amount of training (volume, intensity and frequency) on a neutral gradient surface. After completing the training program each participant will perform again the series of tests. Once all the data is collected, statistical test will be performed in order to learn about the effect of ECC training program on overweight and obese children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric treadmill training | Experimental | Other: EXERCISEThe intervention group will perform an 8 week program, 2 sessions a week for a total of 16 sessions. training will be done on a designated negative gradient treadmill. first two session will be in -5% gradient. sessions 3,4 and 5 will be in -10% gradient, all of the following sessions will be in -15% gradient. exercise intensity will be 70%-80% out of maximal heart-rate. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. each training will start and end with a 2 minutes of warm up and calm down under neutral gradient. Every two minutes of training, Visual Analog Scale and Rating of Perceived Exertion data will be collected from the participants. |
| Control group | Experimental | Other: EXERCISEThe control group will receive the same amount of training under neutral gradient surface(0%).The program will be 8 weeks while in each week there will be two exercise sessions and a total of 16 sessions. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. Training intensity will be 70%-80% out of maximal heart-rate. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children and adolescents aged 5-18.
- Children and adolescents with overweight defined as BMI percentile over 85%.
- Children and adolescents who are able to perform moderate physical activity.
- Children and adolescents that participate in 'Meir' hospital sports and health centre.
Key exclusion criteria (2 listed)
- Participant that does not wish to participate - will not be obligated to do so, and shall not participate in the study.
- Participants with orthopaedic history in the past two years.
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 |
|---|---|---|
| EXERCISEThe intervention group will perform an 8 week program, 2 sessions a weak for a total of 16 sessions. training will be done on a designated negative gradient treadmill, first two session will be in -5% gradient. sessions 3,4 and 5 will be in -10% gradient, all of the following sessions will be in -15% gradient. exercise intensity will be 70%-80% out of maximal heart-rate. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. each training will start and end with a 2 minutes of warm up and calm down under neutral gradient. Every two minutes of training, Visual Analog Scale and Rating of Perceived Exertion data will be collected from the participants. | Other | Control group, Eccentric treadmill training |
Primary outcome
Physical fitness
Time frame: 8 weeks
participants will show changes in physical activity-run/walk perseverance time.
BMI Percentile
Time frame: 8 weeks
participants will show changes in BMI Percentile
Muscle strength by Hand-held Dynamometer(newton)
Time frame: 8 weeks
participants will show changes in quadriceps and hamstring group muscles strength.
Tibial Bone Strength by US(m/s)
Time frame: 8 weeks
participants will show changes in tibial bone strength
Peak Positive Acceleration (PPA)
Time frame: 8 weeks
participants will show changes in tibial bone acceleration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE in people with Childhood Obesity, run by Meir Medical Center at 1 site in Israel.
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 4 inclusion and 2 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 26 Feb 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 Israel. 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?
Contact Dan Nemet, MD (972-97471596, Dan.Nemet@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical fitness (time frame: 8 weeks). The study lists 5 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 26 Feb 2020.