Quadriceps MuscleNCT03950596
Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load
A study testing Acute resistant load exercises, Background Questionnaire and Pain Questionnaire in people with Quadriceps Muscle, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine the influence of acute resistance exercises on anatomical and biological changes in the quadriceps muscle and tendons of the knee Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Muscle
- What is being tested?
- Acute resistant load exercises, Background Questionnaire and Pain Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2019to May 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-professional athletes
- Pass heart/lung endurance tests
- Pass ergometrics testing
Who cannot join
- Have been injured
- Had physiotherapy for back or lower limbs in past 6 months
- Orthopedic surgery in lower limbs
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Eias Kassem, MD, eiask@hy.health.gov.il
Eias Kassem, MD
About this study
The aim of this study is to determine the influence of acute resistance exercises on anatomical and biological changes in the quadriceps muscle and tendons of the knee
- Conditions
- Quadriceps Muscle
- Being tested
- Acute resistant load exercises, Background Questionnaire, Pain Questionnaire, DNA and RNA test, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute resistant load exercisesOther
Leg bench and leg press acute resistant load exercises
Leg-bench and leg-press acute resistant load exercises
Background QuestionnaireBehavioural
Background questionnaire will be filled out by participants
Pain QuestionnaireOther
Pain questionnaire regarding pain in the knee during previous 3 months
DNA and RNA testGenetic
DNA and RNA tests will be sent to a genetic laboratory for analysis
UltrasoundDiagnostic test
Ultrasound of the knee joint and the quadriceps muscle and the pica tendon
Percutaneous Needle Core BiopsyDiagnostic test
Core Biopsy will be taken from the quadriceps femoris muscle
| Study group | Role | What they receive |
|---|---|---|
| One acute resistance load exercise | Active comparator | One hundred volunteers will participate in one acute resistance load exercises to their quadriceps Receives: Other: Acute resistant load exercises; Behavioral: Background Questionnaire; Other: Pain Questionnaire; Genetic: DNA and RNA test; Diagnostic Test: Ultrasound; Diagnostic Test: Percutaneous Needle Core Biopsy |
| Three acute resistance load exercises | Active comparator | One hundred volunteers will participate in three acute resistance load exercises to their quadriceps Receives: Other: Acute resistant load exercises; Behavioral: Background Questionnaire; Other: Pain Questionnaire; Genetic: DNA and RNA test; Diagnostic Test: Ultrasound; Diagnostic Test: Percutaneous Needle Core Biopsy |
| Control Group | Active comparator | One hundred volunteers will participate in study as a control group Receives: Behavioral: Background Questionnaire; Other: Pain Questionnaire; Genetic: DNA and RNA test; Diagnostic Test: Ultrasound; Diagnostic Test: Percutaneous Needle Core Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Changes in Knee Muscle and Tendon
Comparison of results of genetic testing both before and after interventions between the 3 groups
Measured: One year
Ultrasound Changes in Knee Muscle and Tendon
Comparison of results of pre- and post ultrasound changes after interventions between the 3 groups
Measured: One year
Biopsy Changes in Knee Muscle and Tendon
Comparison of changes in biopsies taken before and after interventions between the 3 groups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriceps MuscleStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950596
- Sponsor's protocol ID
- HYMC-58-16
- Status last verified
- May 2019
- First submitted
- 1 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load
- ClinicalTrials.gov ID
- NCT03950596
- Acronym / sponsor ID
- HYMC-58-16
- Conditions
- Quadriceps Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 15 May 2019 (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 this study is to determine the influence of acute resistance exercises on anatomical and biological changes in the quadriceps muscle and tendons of the knee
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One acute resistance load exercise | Active comparator | Other: Acute resistant load exercises, Behavioral: Background Questionnaire, Other: Pain Questionnaire, Genetic: DNA and RNA test, Diagnostic Test: Ultrasound, Diagnostic Test: Percutaneous Needle Core BiopsyOne hundred volunteers will participate in one acute resistance load exercises to their quadriceps |
| Three acute resistance load exercises | Active comparator | Other: Acute resistant load exercises, Behavioral: Background Questionnaire, Other: Pain Questionnaire, Genetic: DNA and RNA test, Diagnostic Test: Ultrasound, Diagnostic Test: Percutaneous Needle Core BiopsyOne hundred volunteers will participate in three acute resistance load exercises to their quadriceps |
| Control Group | Active comparator | Behavioral: Background Questionnaire, Other: Pain Questionnaire, Genetic: DNA and RNA test, Diagnostic Test: Ultrasound, Diagnostic Test: Percutaneous Needle Core BiopsyOne hundred volunteers will participate in study as a control group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-professional athletes
- Pass heart/lung endurance tests
- Pass ergometrics testing
Key exclusion criteria (3 listed)
- Have been injured
- Had physiotherapy for back or lower limbs in past 6 months
- Orthopedic surgery in lower limbs
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 |
|---|---|---|
| Acute resistant load exercisesLeg bench and leg press acute resistant load exercises Leg-bench and leg-press acute resistant load exercises | Other | One acute resistance load exercise, Three acute resistance load exercises |
| Background QuestionnaireBackground questionnaire will be filled out by participants | Behavioural | Control Group, One acute resistance load exercise, Three acute resistance load exercises |
| Pain QuestionnairePain questionnaire regarding pain in the knee during previous 3 months | Other | Control Group, One acute resistance load exercise, Three acute resistance load exercises |
| DNA and RNA testDNA and RNA tests will be sent to a genetic laboratory for analysis | Genetic | Control Group, One acute resistance load exercise, Three acute resistance load exercises |
| UltrasoundUltrasound of the knee joint and the quadriceps muscle and the pica tendon | Diagnostic test | Control Group, One acute resistance load exercise, Three acute resistance load exercises |
| Percutaneous Needle Core BiopsyCore Biopsy will be taken from the quadriceps femoris muscle | Diagnostic test | Control Group, One acute resistance load exercise, Three acute resistance load exercises |
Primary outcome
Genetic Changes in Knee Muscle and Tendon
Time frame: One year
Comparison of results of genetic testing both before and after interventions between the 3 groups
Ultrasound Changes in Knee Muscle and Tendon
Time frame: One year
Comparison of results of pre- and post ultrasound changes after interventions between the 3 groups
Biopsy Changes in Knee Muscle and Tendon
Time frame: One year
Comparison of changes in biopsies taken before and after interventions between the 3 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute resistant load exercises, Background Questionnaire and Pain Questionnaire in people with Quadriceps Muscle, run by Hillel Yaffe 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 3 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: status not confirmed, as of the sponsor's last update on 15 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eias Kassem, MD (972-50-6246882, eiask@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Changes in Knee Muscle and Tendon (time frame: One year). The study lists 3 primary outcomes in all. 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 15 May 2019.