Obesity, ChildhoodNCT03076073
Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
A study testing Impact of physical activity on tendons in people with Obesity, Childhood and Obesity, run by Meir Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Obesity, Tendon Thickening
- What is being tested?
- Impact of physical activity on tendons
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 20 May 2017to 29 Sep 2020
- 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 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- participants that had orthopedic surgery or professional athletes.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Studies showed that the probability of tendon abnormalities is higher in obese subjects compared to normal weight peer. Adiposity has been recognized as a risk factor for alterations in load- bearing tendons; and, different impact of loading exercises on tendon structure has been reported for obese individuals compared to normal weight individuals. 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.
Tendon structure would be evaluated with UTC-imaging ultrasound device. UTC imaging allows for three-dimensional imaging of the tendon, semi- quantification of structure, and calculation of tendon dimensions. The resultant UTC analysis quantify the tendon into four echo types (I-IV) based on the stability of pixel brightness over contiguous images allowing inferences to be made on the alignment of tendon bundles. Briefly, echo types I and II correspond with relatively high stability in gray-scale pixel brightness over contiguous images due to one resulting US signal transmission. These echo types correspond with aligned fibrillar structure (AFS) within the tendon. Echo types III and IV are generated by multiple signal transmission that interfere as a consequence of multiple interfaces. These echo types represent a disorganized amorphous fibrillar structure that has non parallel fiber arrangement. For this study, the relative percentage and (muscle cross section area (mCSA) of these parameters were the main outcomes investigated. A linear-array US transducer (SmartProbe, A 10- megahertz (MHz) linear-array transducer, USA) mounted within a customized tracking device with motor drive and built-in acoustic stand off pad (UTC Tracker, UTC Imaging, Netherlands) was placed on the skin, perpendicular to the long axis of the tendon (Achilles or patellar), ensuring that the calcaneus or inferior pole of the patella was visible. Coupling gel was applied between the transducer, standoff pad, and skin to ensure maximum contact. Once a clear transverse image of the tendon and bony landmark was established, the motor drive automatically moved the transducer over the length of the tendon capturing a transverse grayscale US image every 0.2 mm over a distance of 12 cm. By compounding these images, a gray-scale US image data block is rendered that allows the tendon to be viewed in three planes: transverse, sagittal, and coronal (UTC2010, UTC Imaging). From this data block, each tendon was classified as either normal or pathological.
Each participant would be measured at both Achilles tendons and both Patellar tendons (total time 10min) while prone position (for the Achilles tendon) and in sitting position (for Patellar tendon). Each screening is for 45sec.
- Participants in different ages and different weight status would be measured for tendon structure
- Tendon structure would be evaluated following single and multiple (up to 12 weeks) aerobic and anaerobic exercises.
- Conditions
- Obesity, Childhood, Obesity, Tendon Thickening
- Being tested
- Impact of physical activity on tendons
- Keywords
- Ultrasound, Achilles tendon, Patellar tendon, obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of physical activity on tendonsOther
Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Impact of physical activity on tendons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound tissue characterization
Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen
Measured: 10min
Secondary outcomes (1)
Ultrasound 3-D visualization of tendon structure
measuring the total volume of the tendon; anterior-posterior and medial-lateral diameters
Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start20 May 2017
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Nemet, MD, Meir Medical Center
- Investigators
- Dan Nemet, Prof., Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076073
- Sponsor's protocol ID
- MeirMc0321-16CTIL
- Status last verified
- Sep 2020
- First submitted
- 5 Mar 2017
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
- ClinicalTrials.gov ID
- NCT03076073
- Acronym / sponsor ID
- MeirMc0321-16CTIL
- Conditions
- Obesity, Childhood, Obesity, Tendon Thickening
- Keywords
- Ultrasound, Achilles tendon, Patellar tendon, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 9 Mar 2017 (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 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.
Detailed description
Studies showed that the probability of tendon abnormalities is higher in obese subjects compared to normal weight peer. Adiposity has been recognized as a risk factor for alterations in load- bearing tendons; and, different impact of loading exercises on tendon structure has been reported for obese individuals compared to normal weight individuals. 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.
Tendon structure would be evaluated with UTC-imaging ultrasound device. UTC imaging allows for three-dimensional imaging of the tendon, semi- quantification of structure, and calculation of tendon dimensions. The resultant UTC analysis quantify the tendon into four echo types (I-IV) based on the stability of pixel brightness over contiguous images allowing inferences to be made on the alignment of tendon bundles. Briefly, echo types I and II correspond with relatively high stability in gray-scale pixel brightness over contiguous images due to one resulting US signal transmission. These echo types correspond with aligned fibrillar structure (AFS) within the tendon. Echo types III and IV are generated by multiple signal transmission that interfere as a consequence of multiple interfaces. These echo types represent a disorganized amorphous fibrillar structure that has non parallel fiber arrangement. For this study, the relative percentage and (muscle cross section area (mCSA) of these parameters were the main outcomes investigated. A linear-array US transducer (SmartProbe, A 10- megahertz (MHz) linear-array transducer, USA) mounted within a customized tracking device with motor drive and built-in acoustic stand off pad (UTC Tracker, UTC Imaging, Netherlands) was placed on the skin, perpendicular to the long axis of the tendon (Achilles or patellar), ensuring that the calcaneus or inferior pole of the patella was visible. Coupling gel was applied between the transducer, standoff pad, and skin to ensure maximum contact. Once a clear transverse image of the tendon and bony landmark was established, the motor drive automatically moved the transducer over the length of the tendon capturing a transverse grayscale US image every 0.2 mm over a distance of 12 cm. By compounding these images, a gray-scale US image data block is rendered that allows the tendon to be viewed in three planes: transverse, sagittal, and coronal (UTC2010, UTC Imaging). From this data block, each tendon was classified as either normal or pathological.
Each participant would be measured at both Achilles tendons and both Patellar tendons (total time 10min) while prone position (for the Achilles tendon) and in sitting position (for Patellar tendon). Each screening is for 45sec.
- Participants in different ages and different weight status would be measured for tendon structure
- Tendon structure would be evaluated following single and multiple (up to 12 weeks) aerobic and anaerobic exercises.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluating Tendons Structures | No intervention | –Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures |
| Impact of physical activity on tendons | Active comparator | Other: Impact of physical activity on tendonsUltrasound measurements of Patellar Tendon and Achilles Tendon Structures following different types and different intensity of physical activity |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- participants that had orthopedic surgery or professional athletes.
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 |
|---|---|---|
| Impact of physical activity on tendonsSingle vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities). | Other | Impact of physical activity on tendons |
Primary outcome
Ultrasound tissue characterization
Time frame: 10min
Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen
1 secondary outcome
Ultrasound 3-D visualization of tendon structure
Time frame: 10min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Dan Nemet, Prof. principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact of physical activity on tendons in people with Obesity, Childhood and 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound tissue characterization (time frame: 10min). 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 30 Sep 2020.