NCT03076073

Brief Summary

The aim of the current study is to evaluate the Patellar tendon and Achilles tendon structures among children, adolescents and adults with different weight status. That in order to improve our understanding on the impact of acute and overused loads on tendon structure; and, in developing strategies to reduce tendon's injuries following physical exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

3.4 years

First QC Date

March 5, 2017

Last Update Submit

September 29, 2020

Conditions

Obesity, ChildhoodObesityTendon Thickening

Keywords

UltrasoundAchilles tendonPatellar tendonobesity

Outcome Measures

Primary Outcomes (1)

  • Ultrasound tissue characterization

    Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen

    10min

Secondary Outcomes (1)

  • Ultrasound 3-D visualization of tendon structure

    10min

Study Arms (2)

Evaluating Tendons Structures

NO INTERVENTION

Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures

Impact of physical activity on tendons

ACTIVE COMPARATOR

Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures following different types and different intensity of physical activity

Other: Impact of physical activity on tendons

Interventions

Impact of physical activity on tendonsOTHER

Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).

Impact of physical activity on tendons

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • participants that had orthopedic surgery or professional athletes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

'Meir children's sport and health center'

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dan Nemet, Prof.

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dan Nemet

Study Record Dates

First Submitted

March 5, 2017

First Posted

March 9, 2017

Study Start

May 20, 2017

Primary Completion

September 29, 2020

Study Completion

September 29, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)