<?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>IRCT20220606055084N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-26</date_registration>
      <primary_sponsor>Muhammad Institute of Medical and Allied Sciences</primary_sponsor>
      <public_title>Effectiveness of exercise along with diaphragmatic breathing in covid-19 survivors</public_title>
      <acronym>interventional</acronym>
      <scientific_title>Effectiveness of upper limb exercise along diaphragmatic breathing with or without lower limb exercise in covid-19 survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>176</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Borg Scale, spirometry, 6-minutes walk test and SF8 questionnaire was used to assess the patients before and after treatment, Randomization description: Allocation concealment occur and patients will be recruited by using simple randomization through lottery method. Lottery method carried out through sealed envelops. Every participants will randomly choose the sealed envelop and open this sealed envelop, Blinding description: Those participants will be unaware of the method of treatment that will be evaluated after the completion of the interventional trial. Subjects will be given the option of choosing between two samples. Both the samples are in the same packing. In one sample, upper limb exercise was performed alongside diaphragmatic breathing exercise in one sample, and lower limb exercise was performed alongside diaphragmatic breathing in the other two samples. Subjects will be completely unaware of the type and effect of both interventions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>corona virus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  group A received upper limb exercise along diaphragmatic breathing for 4 week (5 session per week). Intervention 2: Intervention group:  Group B received upper limb along diaphragmatic breathing with lower limb exercise for 4 week( per week 5 session).</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:
Effectiveness of upper limb exercise along diaphragmatic breathing with or without lower limb exercise in COVID-19 survivors

When:
this will be available at the end of 2022

To whom:
Farah zahid

Conditions:
for reserach purpose

Where to obtain:
https://www.researchgate.net/

How to obtain:
open assess

Comments:
I want randomized clinical trial registration, please provide me as soon as possible so that i can continue my study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zahid Manzoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street Sabzazar, Bosan road, Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 336 6389053</telephone>
        <email>anamzulfiqar049@gmail.com</email>
        <affiliation>Muhammad institute of medical and allied sciences, Multan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farah Zahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street sabzazar metro station bosan road multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 336 6389053</telephone>
        <email>anamzulfiqar049@gmail.com</email>
        <affiliation>Muhammad institute of medical and allied sciences, Multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Between the ages of 35-60 years
Both male and female
COVID-19 survivors; 
Discharged from the hospital six weeks ago (diagnosed with COVID-19, with respiratory illness)</inclusion_criteria>
      <agemin>36 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any of the following: fever; new or worsening respiratory symptoms &gt; 38.2 degrees Celsius (e.g., cough, dyspnea) in the last 14 days, 
Pregnant females
Refusal to give consent approval.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  group A received upper limb exercise along diaphragmatic breathing for 4 week (5 session per week)</i_keyword>
      <i_keyword>Intervention group:  Group B received upper limb along diaphragmatic breathing with lower limb exercise for 4 week( per week 5 session)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory function. Timepoint: before and after treatment(4 week duration). Method of measurement: brog scale, spirometry, 6-minutes walk test and SF8 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Endurance. Timepoint: Before and after treatment(4 week duration). Method of measurement: borg scale, spirometry, 6-minutes walk test and SF8 questionnaire.</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>Muhammad Institute of Medical and Allied Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-18</approval_date>
        <contact_name>Institutional ethical committee of Muhammad institute of medical and allied science Multan</contact_name>
        <contact_address>HBL street near sabzazar metro station busan road, Multan Multan punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
