<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230329057784N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-05</date_registration>
      <primary_sponsor>Prince Sattam Bin Abdulaziz University</primary_sponsor>
      <public_title>The difference between fatigue of quadriceps and hamstrings muscles on knee biomechanics during landing on one limb</public_title>
      <acronym></acronym>
      <scientific_title>Is there a difference in knee biomechanics due to fatigue of the quadriceps versus hamstrings during landing on a single limb? Three-dimensional analysis study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69646</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: Each of the 108 athletes was given a number. A researcher not involved in the study performed the randomization using sealed envelopes. Each envelope was labeled as either a Quadriceps group "Intervention group 1" or a Hamstring group "Intervention group 2". Each athlete was requested to choose a sealed envelope using a 1:1 simple randomization. The examining researcher/assessor was not included in the randomization process and was unaware of the group allocation. Athletes will be asked not to report their treatment allocation to the examiner/researcher during their assessment, Blinding description: The athletes were recruited and assigned randomly into one of the two groups. Based on the simple randomization design 1:1 ratio, A researcher not involved in the study performed the randomization using sealed envelopes. Each envelope was labeled as either a Quadriceps group "Intervention group 1" or a Hamstring group "Intervention group 2". Each athlete was requested to choose a sealed envelope. The examining researcher/assessor was not included in the randomization process and was unaware of the group allocation so, the outcome assessor/investigator researcher will examine the outcome measures without knowing the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: the effects of the fatigued quadriceps muscle. Condition 2: 2- We will study the effects of the fatigued hamstring muscle.</hc_freetext>
      <i_freetext>Intervention 1: In Intervention Group 1 (quadriceps muscle group), the 3D kinematic and kinetic data of the knee joint will be collected before and after the fatigue protocol applied to the quadriceps muscle during a single-leg landing in a forward-drop jump task. The 3D motion analysis system consists of the 12 infrared cameras (100Hz) of motion capture system Vicon (Oxford Metrics Limited UK), and two ground reaction forces collect synchronously at 2000 Hz with an AMTI GEN–5 force plate (Watertown, MA, USA). The participant will stand over a 30-cm height box, which will be placed 20 cm behind the force plate form, and perform a forward drop jump onto the force plate, landing on the forefoot (metatarsal heads) with a dominant single leg. The peak torque of quadriceps muscles will be determined by an isokinetic dynamometer (CSMI Humac 2009, Cybex II, II+, version 129, USA) to measure maximal voluntary concentric contraction (MVCC) at 120°.s-1 and the range of motion, in which the measured peak torque, is available from 10 to 90 degrees of knee flexion. The fatigue protocol commences with performing three consecutive repetitions of knee extension of MVCC at 300°.s-1 (16) until the torque measured in the quadriceps declines below 50% of the participant's baseline peak torque value. A 30-second rest will be provided to the participant who will be asked again to replicate MVCC of knee extension until the baseline of peak torque of quadriceps muscle drops to 50% of its value. The cycle of MVCC and rest will be repeated. If five consecutive cycles decrease the baseline of quadriceps' baseline of peak torque to 50%, fatigue is achieved. Intervention 2: In Intervention Group 2 (hamstrings muscle group), the 3D kinematic and kinetic data of the knee joint will be collected before and after the fatigue protocol applied to the hamstrings muscle during a single-leg landing in a forward-drop jump task. The 3D motion analysis system consists of the 12 infrared cameras (100Hz) of motion capture system Vicon (Oxford Metrics Limited UK), and two ground reaction forces collect synchronously at 2000 Hz with an AMTI GEN–5 force plate (Watertown, MA, USA). The participant will stand over a 30-cm height box, which will be placed 20 cm behind the force plate form, and perform a forward drop jump onto the force plate, landing on the forefoot (metatarsal heads) with a dominant single leg. The peak torque of hamstrings muscles will be determined by an isokinetic dynamometer (CSMI Humac 2009, Cybex II, II+, version 129, USA) to measure maximal voluntary concentric contraction (MVCC) at 120°.s-1 and the range of motion, in which the measured peak torque, is available from 10 to 90 degrees of knee flexion. The fatigue protocol commences with performing three consecutive repetitions of knee flexion of MVCC at 300°.s-1 (16) until the torque measured in the hamstrings declines below 50% of the participant's baseline peak torque value. A 30-second rest will be provided to the participant who will be asked again to replicate MVCC of knee flexion until the baseline of peak torque of hamstrings muscle drops to 50% of its value. The cycle of MVCC and rest will be repeated. If five consecutive cycles decrease the baseline of hamstring's baseline of peak torque to 50%, fatigue is achieved.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Patient information sheet, raw data, results

When:
After publication

To whom:
Public

Conditions:
Statistical analysis

Where to obtain:
Researchgate

How to obtain:
via email. research gate

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Waleed Salah Eldin Mahmoud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Aljamaa District, King Abdulla street, Alkharj, Riyadh, Saudi Arabia</address>
        <city>Al-Kharj</city>
        <country1>Saudi Arabia</country1>
        <zip>11942</zip>
        <telephone>+966 56 311 4324</telephone>
        <email>waleeds306@yahoo.com</email>
        <affiliation>Prince Sattam Bin Abdulaziz University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Waleed Salah Eldin Mahmoud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>King Abduallah Abdulaziz street</address>
        <city>Al-Kharj</city>
        <country1>Saudi Arabia</country1>
        <zip>11942</zip>
        <telephone>+966 56 311 4324</telephone>
        <email>waleeds306@yahoo.com</email>
        <affiliation>Prince Sattam Bin Abdulaziz University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Saudi Arabia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age ranged from 20-25 years.
A minimum of five-year experience in the recorded sport was required.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of cardiovascular problems.
History of respiratory problems.
History of neurological disorders.
History of neurological problems.
Anterior cruciate ligament injury.
Previous lower extremity injury.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T73.3XXA</hc_code>
      <hc_code>T73.3XXA</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Exhaustion due to excessive exertion, initial encounter</hc_keyword>
      <hc_keyword>Exhaustion due to excessive exertion, initial encounter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In Intervention Group 1 (quadriceps muscle group), the 3D kinematic and kinetic data of the knee joint will be collected before and after the fatigue protocol applied to the quadriceps muscle during a single-leg landing in a forward-drop jump task. The 3D motion analysis system consists of the 12 infrared cameras (100Hz) of motion capture system Vicon (Oxford Metrics Limited UK), and two ground reaction forces collect synchronously at 2000 Hz with an AMTI GEN–5 force plate (Watertown, MA, USA). The participant will stand over a 30-cm height box, which will be placed 20 cm behind the force plate form, and perform a forward drop jump onto the force plate, landing on the forefoot (metatarsal heads) with a dominant single leg. The peak torque of quadriceps muscles will be determined by an isokinetic dynamometer (CSMI Humac 2009, Cybex II, II+, version 129, USA) to measure maximal voluntary concentric contraction (MVCC) at 120°.s-1 and the range of motion, in which the measured peak torque, is available from 10 to 90 degrees of knee flexion. The fatigue protocol commences with performing three consecutive repetitions of knee extension of MVCC at 300°.s-1 (16) until the torque measured in the quadriceps declines below 50% of the participant's baseline peak torque value. A 30-second rest will be provided to the participant who will be asked again to replicate MVCC of knee extension until the baseline of peak torque of quadriceps muscle drops to 50% of its value. The cycle of MVCC and rest will be repeated. If five consecutive cycles decrease the baseline of quadriceps' baseline of peak torque to 50%, fatigue is achieved.</i_keyword>
      <i_keyword>In Intervention Group 2 (hamstrings muscle group), the 3D kinematic and kinetic data of the knee joint will be collected before and after the fatigue protocol applied to the hamstrings muscle during a single-leg landing in a forward-drop jump task. The 3D motion analysis system consists of the 12 infrared cameras (100Hz) of motion capture system Vicon (Oxford Metrics Limited UK), and two ground reaction forces collect synchronously at 2000 Hz with an AMTI GEN–5 force plate (Watertown, MA, USA). The participant will stand over a 30-cm height box, which will be placed 20 cm behind the force plate form, and perform a forward drop jump onto the force plate, landing on the forefoot (metatarsal heads) with a dominant single leg. The peak torque of hamstrings muscles will be determined by an isokinetic dynamometer (CSMI Humac 2009, Cybex II, II+, version 129, USA) to measure maximal voluntary concentric contraction (MVCC) at 120°.s-1 and the range of motion, in which the measured peak torque, is available from 10 to 90 degrees of knee flexion. The fatigue protocol commences with performing three consecutive repetitions of knee flexion of MVCC at 300°.s-1 (16) until the torque measured in the hamstrings declines below 50% of the participant's baseline peak torque value. A 30-second rest will be provided to the participant who will be asked again to replicate MVCC of knee flexion until the baseline of peak torque of hamstrings muscle drops to 50% of its value. The cycle of MVCC and rest will be repeated. If five consecutive cycles decrease the baseline of hamstring's baseline of peak torque to 50%, fatigue is achieved.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The peak knee flexion angle (in degrees). Timepoint: Pre- and post-fatigue program. Method of measurement: 3D motion analysis system (Vicon).</prim_outcome>
      <prim_outcome>The peak vGRF (expressed in BW) at initial contact. Timepoint: Pre- and post-fatigue program. Method of measurement: Force plate forms (Vicon).</prim_outcome>
      <prim_outcome>The proximal tibial anterior shear force was measured in (Nm/Kg). Timepoint: Pre- and post-fatigue program. Method of measurement: 3D motion analysis system (Vicon).</prim_outcome>
      <prim_outcome>The knee flexion-extension moments. Timepoint: Pre- and post-fatigue program. Method of measurement: 3D motion analysis system (Vicon).</prim_outcome>
      <prim_outcome>Knee valgus-varus moment were measured in (Nm/Kg*m). Timepoint: Pre- and post-fatigue program. Method of measurement: 3D motion analysis system (Vicon).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Prince Sattam Bin Abdulaziz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-10</approval_date>
        <contact_name>The Standing Committee of Bioethics Research (SCBR).</contact_name>
        <contact_address>King Abduallah Abdulaziz street Al-Kharj Riyadh Saudi Arabia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
