<?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>IRCT20231115060065N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-06</date_registration>
      <primary_sponsor>University of Medicine and Pharmacy Victor Babes Timisoara</primary_sponsor>
      <public_title>Progressive muscle relaxation techniques in patients with COVID-19 symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Enhancing Symptom Management in Long-COVID 19 Patients: A Comparative Study of Pulmonary Rehabilitation and Progressive Muscle Relaxation Techniques</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74029</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomized to either an interventional group or a control group according to their moment of admission. The patients who were admitted to the study at the same time were assigned to different treatment groups. This method of randomization was used to ensure that the patients in the two groups were similar in terms of their time of admission, which could affect the outcome of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post COVID-19 condition.</hc_freetext>
      <i_freetext>Intervention group: pulmonary rehabilitation and additional progressive muscle relaxation techniques.  The patients performed the pulmonary rehabilitation program for 21 days, twice a day. The pulmonary rehabilitation program included: gradual aerobic conditioning, strength training focusing on the major muscle groups, and breathing exercises with an emphasis on pursed lip breathing, double inhale breathing, and chest expansion exercises. The intervention group engaged in additional daily 20-minute PMR sessions focusing on progressively tensing and then relaxing major muscle groups, starting from the hands and moving up through the body, while maintaining slow, deep breathing. The program involved tensing the muscle group for 5 seconds and then releasing and relaxing for 20 seconds..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Crisan Alexandru Florian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eftimie Murgu</address>
        <city>Timisoara</city>
        <country1>Romania</country1>
        <zip>300041</zip>
        <telephone>+40 765 525 688</telephone>
        <email>crisan@umft.ro</email>
        <affiliation>University of Medicine and Pharmacy Victor Babes Timisoara</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Crisan Alexandru Florian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eftimie Murgu</address>
        <city>Timisoara</city>
        <country1>Romania</country1>
        <zip>300041</zip>
        <telephone>+40 765 525 688</telephone>
        <email>crisan@umft.ro</email>
        <affiliation>University of Medicine and Pharmacy Victor Babes Timisoara</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Romania</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Previous infection with COVID-19
Age over 18 years
Primary symptom of dyspnea and fatigability lasting for over one month</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe heart disease
Severe ischemic or hemorrhagic stroke
Severe cognitive impairment
Medication that could potentially affect their exercise responses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U09.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post COVID-19 condition, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: pulmonary rehabilitation and additional progressive muscle relaxation techniques.  The patients performed the pulmonary rehabilitation program for 21 days, twice a day. The pulmonary rehabilitation program included: gradual aerobic conditioning, strength training focusing on the major muscle groups, and breathing exercises with an emphasis on pursed lip breathing, double inhale breathing, and chest expansion exercises. The intervention group engaged in additional daily 20-minute PMR sessions focusing on progressively tensing and then relaxing major muscle groups, starting from the hands and moving up through the body, while maintaining slow, deep breathing. The program involved tensing the muscle group for 5 seconds and then releasing and relaxing for 20 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduced general anxiety level. Timepoint: before intervention and 3 weeks after intervention. Method of measurement: GAD-7 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improved sleep quality. Timepoint: before intervention and 3 weeks after intervention. Method of measurement: PSQI questionnaire.</sec_outcome>
      <sec_outcome>Improved overall health. Timepoint: before intervention and 3 weeks after intervention. Method of measurement: GHQ-12 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>University of Medicine and Pharmacy Victor Babes Timisoara</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-30</approval_date>
        <contact_name>Comisia de Etică a Spitalului de Boli Infectioase si Pneumoftiziologie Victor Babes Timisoara</contact_name>
        <contact_address>Gheorghe Adam nr. 13 Timisoara Timis Romania</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
