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

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 Overview

• Status: Unknown
• Conditions: Quadriceps Muscle
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
    • Principal Investigator: Eias Kassem, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic Changes in Knee Muscle and Tendon	Comparison of results of genetic testing both before and after interventions between the 3 groups	One year
Ultrasound Changes in Knee Muscle and Tendon	Comparison of results of pre- and post ultrasound changes after interventions between the 3 groups	One year
Biopsy Changes in Knee Muscle and Tendon	Comparison of changes in biopsies taken before and after interventions between the 3 groups	One year

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HYMC-58-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No