<?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>IRCT20210214050356N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Muscle Release Treatment in Patients Infected by Corona- Virus</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Myofascial Release Therapy on the Respiratory Functions in Patients with COVID- 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be based on a single sequence (simple randomization) and the random number table method will be used, so that the table is read from above and even numbers will be considered for the control group and odd numbers for the intervention group (myofascial release).Allocation concealment will be done using sealed opaque envelopes. In this way, 50 envelopes are prepared with aluminum wrappers and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. Finally, the lid of the envelope is glued and placed inside a box, respectively. At the beginning of the study, one of the envelopes is opened in order and the assigned group of the patient is revealed, Blinding description: The present study will be single blinded. In this way, the participants and the therapist, who is the evaluator too, are aware of the study groups. But the date analyzer will be unaware of the study's groups (control or release of fascia).</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID- 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to routine respiratory physiotherapy, 4  myofascial release techniques including : sub occipital release technique, anterior thoracic and sternal myofascial, anterior cervical myofascial, and diaphragm will  be performed for approximately 5 minutes for each technique. Intervention 2: Control group: Routine respiratory physiotherapy will be performed, which includes: 1) Breathing exercises training (deep inhalation and exhalation) 2) Cough training 3) Diaphragmatic training (For diaphragmatic training, each person performs 30 diaphragmatic breaths in the supine position and a medium weight ( 1 kg) will be placed on the anterior abdominal wall to resist the descent of the diaphragm.) 4) Using external vibration to drain mucus. Because posture plays a vital role in respiratory function, patients should be encouraged to be as erect as possible in the head and neck during these procedures and to avoid slumped position.</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:
All data is potentially shareable after unidentified individuals.

When:
Access period starts 3 months after the articles are published.

To whom:
For researchers working in academic, scientific and hospital institutions

Conditions:
Researchers working in the field of lung diseases and respiratory care and manual therapies.

Where to obtain:
Applicants for documentation can contact Dr. Sara Fereydoonnia via email.
S-fereydounnia@sina.tums.ac.ir

How to obtain:
Once they have the necessary criteria, the information will be provided to them within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Fereydounnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche shemiran, Enghelab Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>s-fereydounnia@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Fereydounnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche- Shemiran, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>S-fereydounnia@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>With definitive diagnosis of Covid-19 (PCR test positive)
More than 6 months have passed since the onset of other acute diseases.
The patient does not have COPD or other respiratory diseases.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Body temperature over 38 degrees
The time of initial diagnosis or onset of symptoms is 3 days or less
The initial onset of dyspnea is 3 days or less
The chest image has improved by more than 50% in the last 24 to 48 hours
SpO2 90% or less
Blood pressure less than 90/60 mm Hg and more than 180/90 mm Hg
The number of breaths is more than 40 per minute
Heart rate less than 40 and more than 120 beats per minute
New onset of arrhythmia and myocardial ischemia
Moderate to severe heart disease (grade 3 or 4, according to the New York Heart Association)
with ischemic or hemorrhagic stroke or neurodegenerative diseases
Decreased level of consciousness
Reluctance to continue treatment and discharge with personal consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to routine respiratory physiotherapy, 4  myofascial release techniques including : sub occipital release technique, anterior thoracic and sternal myofascial, anterior cervical myofascial, and diaphragm will  be performed for approximately 5 minutes for each technique.</i_keyword>
      <i_keyword>Control group: Routine respiratory physiotherapy will be performed, which includes: 1) Breathing exercises training (deep inhalation and exhalation) 2) Cough training 3) Diaphragmatic training (For diaphragmatic training, each person performs 30 diaphragmatic breaths in the supine position and a medium weight ( 1 kg) will be placed on the anterior abdominal wall to resist the descent of the diaphragm.) 4) Using external vibration to drain mucus. Because posture plays a vital role in respiratory function, patients should be encouraged to be as erect as possible in the head and neck during these procedures and to avoid slumped position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart Rate. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Cardiopulmonary Monitoring.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Cardiopulmonary Monitoring.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Cardiopulmonary Monitoring.</prim_outcome>
      <prim_outcome>Blood O2 Saturation. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Pulse Oximetry.</prim_outcome>
      <prim_outcome>Chest Expansion. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Tape meter.</prim_outcome>
      <prim_outcome>Ease of Breathing. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: VAS ruler.</prim_outcome>
      <prim_outcome>Dyspnea perception. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Modified Borg Scale.</prim_outcome>
      <prim_outcome>Fatigue Perception. Timepoint: Before Intervention- After the first session and third sessions. Method of measurement: Modified Borg Scale.</prim_outcome>
      <prim_outcome>Exercise Tolerance. Timepoint: Before Intervention- After the third session. Method of measurement: Six Minutes Walking Test.</prim_outcome>
      <prim_outcome>Patient’s thoughts about the treatment. Timepoint: Before Intervention- After the third session. Method of measurement: Six Minutes Walking Test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-04</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
