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Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load

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ClinicalTrials.gov Identifier: NCT03950596
Recruitment Status : Unknown
Verified May 2019 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Quadriceps Muscle 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: One acute resistance load exercise
One hundred volunteers will participate in one acute resistance load exercises to their quadriceps
Other: Acute resistant load exercises

Leg bench and leg press acute resistant load exercises

Leg-bench and leg-press acute resistant load exercises


Behavioral: Background Questionnaire
Background questionnaire will be filled out by participants

Other: Pain Questionnaire
Pain questionnaire regarding pain in the knee during previous 3 months

Genetic: DNA and RNA test
DNA and RNA tests will be sent to a genetic laboratory for analysis

Diagnostic Test: Ultrasound
Ultrasound of the knee joint and the quadriceps muscle and the pica tendon

Diagnostic Test: Percutaneous Needle Core Biopsy
Core Biopsy will be taken from the quadriceps femoris muscle

Active Comparator: Three acute resistance load exercises
One hundred volunteers will participate in three acute resistance load exercises to their quadriceps
Other: Acute resistant load exercises

Leg bench and leg press acute resistant load exercises

Leg-bench and leg-press acute resistant load exercises


Behavioral: Background Questionnaire
Background questionnaire will be filled out by participants

Other: Pain Questionnaire
Pain questionnaire regarding pain in the knee during previous 3 months

Genetic: DNA and RNA test
DNA and RNA tests will be sent to a genetic laboratory for analysis

Diagnostic Test: Ultrasound
Ultrasound of the knee joint and the quadriceps muscle and the pica tendon

Diagnostic Test: Percutaneous Needle Core Biopsy
Core Biopsy will be taken from the quadriceps femoris muscle

Active Comparator: Control Group
One hundred volunteers will participate in study as a control group
Behavioral: Background Questionnaire
Background questionnaire will be filled out by participants

Other: Pain Questionnaire
Pain questionnaire regarding pain in the knee during previous 3 months

Genetic: DNA and RNA test
DNA and RNA tests will be sent to a genetic laboratory for analysis

Diagnostic Test: Ultrasound
Ultrasound of the knee joint and the quadriceps muscle and the pica tendon

Diagnostic Test: Percutaneous Needle Core Biopsy
Core Biopsy will be taken from the quadriceps femoris muscle




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-professional athletes
  • Pass heart/lung endurance tests
  • Pass ergometrics testing

Exclusion Criteria:

  • Have been injured
  • Had physiotherapy for back or lower limbs in past 6 months
  • Orthopedic surgery in lower limbs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950596


Contacts
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Contact: Eias Kassem, MD 972-50-6246882 eiask@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: Eias Kassem, MD       eiask@hy.health.gov.il   
Principal Investigator: Eias Kassem, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03950596    
Other Study ID Numbers: HYMC-58-16
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No