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

Primary Purpose

Childhood Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EXERCISE
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Obesity focused on measuring eccentric training, childhood obesity, decline treadmill

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 'Meir children's sport and health center'Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Eccentric treadmill training

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 25, 2019
Last Updated
February 23, 2020
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04284670
Brief Title
The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children
Official Title
The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
eccentric training, childhood obesity, decline treadmill

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eccentric treadmill training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EXERCISE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical fitness
Description
participants will show changes in physical activity-run/walk perseverance time.
Time Frame
8 weeks
Title
BMI Percentile
Description
participants will show changes in BMI Percentile
Time Frame
8 weeks
Title
Muscle strength by Hand-held Dynamometer(newton)
Description
participants will show changes in quadriceps and hamstring group muscles strength.
Time Frame
8 weeks
Title
Tibial Bone Strength by US(m/s)
Description
participants will show changes in tibial bone strength
Time Frame
8 weeks
Title
Peak Positive Acceleration (PPA)
Description
participants will show changes in tibial bone acceleration.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Nemet, MD
Phone
972-97471596
Email
Dan.Nemet@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Pantanowitz, PhD
Phone
972-9-7471596
Email
michal.pantanowitz@clalit.org.il
Facility Information:
Facility Name
'Meir children's sport and health center'
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Phone
972-9-7471076
Email
dan.nemet@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD

12. IPD Sharing Statement

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

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