<?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>IRCT20221126056606N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-25</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of 3 different recovery modalities on fatigue induced by prolonged sitting in sedentary adults</public_title>
      <acronym></acronym>
      <scientific_title>Fatigue and Recovery-related Changes in Postural and Core Stability, Back and Hamstring Muscle Strength, and Spine Mobility in Sedentary Adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This is a cross-sectional study to model the process of fatigue and recovery-related changes in postural and core stability, back and hamstring muscle strength, and spine mobility in sedentary middle-age adults at risk of low back pain, Randomization description: Restricted randomization, Permuted block randomization:
For randomization, the ‘proc plan’ procedure in the SAS software (ver. 9.1; SAS Institute, Cary, NC, USA) will be used. Using a block randomization method, 160 subjects will be divided randomly into 4 groups in a 1:1:1:1 ratio (block size, 4).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Trunk Stability Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors. Intervention 2: Second intervention group: Foam Rolling Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors. Intervention 3: Third Intervention group: Diaphragmatic Breathing Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors. Intervention 4: Control group: Lying on the bed will be applied as a passive recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.</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:
Just that part of the data that includes the main results of the work can be shared, which means that the data related to the personal characteristics of the participants will not be shared.

When:
April 2024 onward

To whom:
Scientific researcher

Conditions:
In case of request for cooperation to perform comparative analysis or validation.

Where to obtain:
Banafsheh Amiri
amirib1392@gnail.com

How to obtain:
I will send data after receiving a request email as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Banafsheh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8, Komeyl Ave., Jomhoori Blvd., Kerman,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4133 889 761</zip>
        <telephone>+98 34 3212 5469</telephone>
        <email>amirib1392@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Banafsheh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8, Komeyl Ave., Jomhoori Blvd., Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4133 889 761</zip>
        <telephone>+98 34 3212 5469</telephone>
        <email>amirib1392@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The sedentary middle-aged adults (aged 25 to 44 years),
At risk of developing non-specific low back pain,
Self-reporting sitting for at least two hours on any working day.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>44 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy;
History of spinal, femoral, or intra-abdominal surgery in the previous 12 months;
Participants having been diagnosed with a congenital anomaly of the spine, arthritis, rheumatoid, infection of the spine and discs, spondylolisthesis, ankylosing spondylitis, spondylosis, tumor, systemic lupus erythematosus, or osteoporosis;
Receiving physiotherapy services 1 month before the beginning of the study;
Having suffered any kind of mental health disorder, including anxiety and depression, during the past 3 years.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Trunk Stability Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.</i_keyword>
      <i_keyword>Second intervention group: Foam Rolling Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.</i_keyword>
      <i_keyword>Third Intervention group: Diaphragmatic Breathing Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.</i_keyword>
      <i_keyword>Control group: Lying on the bed will be applied as a passive recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural stability. Timepoint: Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up. Method of measurement: FiTRO Sway Check (FiTRONiC, Bratislava, Slovakia).</prim_outcome>
      <prim_outcome>Core stability. Timepoint: Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up. Method of measurement: Gyko inertial sensor system (Microgate, Bolzano, Italy).</prim_outcome>
      <prim_outcome>Maximal isometric back extensor muscle strength. Timepoint: Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up. Method of measurement: FiTRO Back Dynamometer (FiTRONiC, Bratislava, Slovakia).</prim_outcome>
      <prim_outcome>Maximal isometric hamstring muscles strength. Timepoint: Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up. Method of measurement: FiTRO Back Dynamometer (FiTRONiC, Bratislava, Slovakia).</prim_outcome>
      <prim_outcome>Spine mobility. Timepoint: Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up. Method of measurement: Spinal Mouse device (Idiag, Volkerswill, Switzerland).</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-07</approval_date>
        <contact_name>Ethics committee of Kerman University of medical sciences</contact_name>
        <contact_address>Deputy of Research, Kerman University of medical sciences, Somayeh Cross way, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
