The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children

Childhood Obesity Clinical Trial

Official title:

The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284670
• Other study ID #: MeirMc0163-19CTIL
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2020
• Source: Meir Medical Center
• Contact: Dan Nemet, MD
• Phone: 972-97471596
• Email: Dan.Nemet[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Childhood Obesity
• Overweight
• Pediatric Obesity

Intervention

Other:
• EXERCISE
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.

Locations

Country	Name	City	State
Israel	'Meir children's sport and health center'	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical fitness	participants will show changes in physical activity-run/walk perseverance time.	8 weeks
Primary	BMI Percentile	participants will show changes in BMI Percentile	8 weeks
Primary	Muscle strength by Hand-held Dynamometer(newton)	participants will show changes in quadriceps and hamstring group muscles strength.	8 weeks
Primary	Tibial Bone Strength by US(m/s)	participants will show changes in tibial bone strength	8 weeks
Primary	Peak Positive Acceleration (PPA)	participants will show changes in tibial bone acceleration.	8 weeks