NCT04284670

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

September 25, 2019

Last Update Submit

February 23, 2020

Conditions

Childhood Obesity

Keywords

eccentric trainingchildhood obesitydecline treadmill

Outcome Measures

Primary Outcomes (5)

  • Physical fitness

    participants will show changes in physical activity-run/walk perseverance time.

    8 weeks

  • BMI Percentile

    participants will show changes in BMI Percentile

    8 weeks

  • Muscle strength by Hand-held Dynamometer(newton)

    participants will show changes in quadriceps and hamstring group muscles strength.

    8 weeks

  • Tibial Bone Strength by US(m/s)

    participants will show changes in tibial bone strength

    8 weeks

  • Peak Positive Acceleration (PPA)

    participants will show changes in tibial bone acceleration.

    8 weeks

Study Arms (2)

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.

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.

Other: EXERCISE

Interventions

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.

Control groupEccentric treadmill training

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

'Meir children's sport and health center'

Kfar Saba, 44281, Israel

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dan Nemet, MD

CONTACT

972-97471596Dan.Nemet@clalit.org.il

Michal Pantanowitz, PhD

CONTACT

972-9-7471596michal.pantanowitz@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Child Health and Sports Center

Study Record Dates

First Submitted

September 25, 2019

First Posted

February 26, 2020

Study Start

February 20, 2020

Primary Completion

July 1, 2021

Study Completion

November 1, 2021

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

IL(1)