Tissue ComplianceNCT02842892
Implication of Stiffness of the Hamstrings, Achilles Tendon and Calf Muscles for Jumping Performance
A study testing Tissue stiffness in people with Tissue Compliance, run by Goethe University at 1 site in Germany.
Trial summary
For optimal jumping performance an adequate interaction of muscles and tendons is required. A parameter in the functional evaluation of both structures is their stiffness (resistance of the tissue against deformation by external forces). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Compliance
- What is being tested?
- Tissue stiffness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Apr 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
Who cannot join
- Drug intake in the past 48 hours
- Pregnancy
- Muscle soreness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, 60487
About this study
For optimal jumping performance an adequate interaction of muscles and tendons is required. A parameter in the functional evaluation of both structures is their stiffness (resistance of the tissue against deformation by external forces). It is unclear so far if higher stiffness values of tendon or muscle or a specific stiffness relation of both tissues is the cause of better jumping performance. The present study examines this based on the Achilles tendon and the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps (squat jump, counter-Movement Jump, Drop-Jump).
The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional study, the jump height of the participants will be measured for each jump form: squat jump (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form is determined randomly. The measurements are carried out within one day. Furthermore the international physical activity questionnaire will be used in order to assess the level of physical activity.
As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar tendon will be detected. The measurement is carried out before the jumps (there are three jumps after one sample jump performed). The measurement is executed non-invasively and completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on the examined tissue will be exerted and measured how much of this can be compressed.
- Conditions
- Tissue Compliance
- Being tested
- Tissue stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue stiffnessOther
| Study group | Role | What they receive |
|---|---|---|
| Squat Jump | Other | Not described Receives: Other: Tissue stiffness |
| Drop Jump | Other | Not described Receives: Other: Tissue stiffness |
| Countermovement Jump | Other | Not described Receives: Other: Tissue stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Stiffness (calf muscles, achilles tendon, hamstring and patellar tendon) using two different tissue compliance meter (Indentometer Pro; Myoton Pro).
Measured: 15 Min.
Secondary outcomes (1)
Jumping performance (counter movement jump, drop jump, squat jump) using a contact time mat (Refitronic)
Measured: 10 Min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue ComplianceStudies 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
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Winfried Banzer, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842892
- Sponsor's protocol ID
- SpM2016-004
- Status last verified
- Feb 2018
- First submitted
- 18 Jul 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Stiffness of the Hamstrings, Achilles Tendon and Calf Muscles for Jumping Performance
- ClinicalTrials.gov ID
- NCT02842892
- Acronym / sponsor ID
- SpM2016-004
- Conditions
- Tissue Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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.
For optimal jumping performance an adequate interaction of muscles and tendons is required. A parameter in the functional evaluation of both structures is their stiffness (resistance of the tissue against deformation by external forces). It is unclear so far if higher stiffness values of tendon or muscle or a specific stiffness relation of both tissues is the cause of better jumping performance. The present study examines this based on the Achilles tendon and the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps (squat jump, counter-Movement Jump, Drop-Jump).
The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional study, the jump height of the participants will be measured for each jump form: squat jump (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form is determined randomly. The measurements are carried out within one day. Furthermore the international physical activity questionnaire will be used in order to assess the level of physical activity.
As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar tendon will be detected. The measurement is carried out before the jumps (there are three jumps after one sample jump performed). The measurement is executed non-invasively and completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on the examined tissue will be exerted and measured how much of this can be compressed.
Study design
- Primary purpose
- Diagnosis
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Squat Jump | Other | Other: Tissue stiffness |
| Drop Jump | Other | Other: Tissue stiffness |
| Countermovement Jump | Other | Other: Tissue stiffness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (3 listed)
- Drug intake in the past 48 hours
- Pregnancy
- Muscle soreness
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 |
|---|---|---|
| Tissue stiffness | Other | Countermovement Jump, Drop Jump, Squat Jump |
Primary outcome
Tissue Stiffness (calf muscles, achilles tendon, hamstring and patellar tendon) using two different tissue compliance meter (Indentometer Pro; Myoton Pro).
Time frame: 15 Min.
1 secondary outcome
Jumping performance (counter movement jump, drop jump, squat jump) using a contact time mat (Refitronic)
Time frame: 10 Min
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 28 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue stiffness in people with Tissue Compliance, run by Goethe University at 1 site in Germany.
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 1 inclusion and 3 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 28 Feb 2018. 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 Germany. 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?
Tissue Stiffness (calf muscles, achilles tendon, hamstring and patellar tendon) using two different tissue compliance meter (Indentometer Pro; Myoton Pro). (time frame: 15 Min.). 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 28 Feb 2018.