<?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>IRCT20191117045462N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-23</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effects of resistance training on inflammatory markers, cardiorespiratory fitness and pulmonary functions in patients with Rheumatoid arthritis.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of resistance training on inflammatory markers, cardiorespiratory fitness and pulmonary functions in patients with Rheumatoid arthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group through Random Sampling sealed opaque enveloped, Blinding description: Investigator will be blind. Assesmnt will be done by 2nd therapist who will not be involved in treatment and data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with rheumatoid arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Resistance exercise training:                                                                              Patients will ask to perform four exercises utilizing large muscle groups (eg, leg press, shoulder press, chest press and pull ups). Intensity will determine during their first resistance exercise session using an established protocol. They will required to complete three sets of 12–15 repetitions during each exercise session. Each exercise session will be last about 20 to 30 minutes, depending on the individual's tolerance and fitness level. Frequency will be aimed for 2-3 sessions per week. This frequency allows for adequate recovery between sessions while providing enough stimulus to improve fitness over time. Mode and intensity of exercise will adjust monthly. Intervention 2: Control group: conventional therapy along with verbal advice about the cardiovascular and arthritis related benefits of exercise for the same period.</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>Aqsa Riaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>95A Lda avenue 1, Raiwind road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 42 35126110</telephone>
        <email>aqsariaz246@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Wajeeha zia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza saeed Rd, Bhabra Block M Gulberg III, Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• Patient with RA
Patients with sedentary lifestyle (no participation in structural exercise for thepreceding 6 months)
RA factor positive
Both males and females
• Age between 40-65 years
• Stable disease</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Joint surgery (in the preceding 6 months)
Cognitive disability
Other joint diseases such as Osteoporosis and Osteoarthritis
Previous history of fracture
• Primary neurological disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other rheumatoid arthritis</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: Resistance exercise training:                                                                              Patients will ask to perform four exercises utilizing large muscle groups (eg, leg press, shoulder press, chest press and pull ups). Intensity will determine during their first resistance exercise session using an established protocol. They will required to complete three sets of 12–15 repetitions during each exercise session. Each exercise session will be last about 20 to 30 minutes, depending on the individual's tolerance and fitness level. Frequency will be aimed for 2-3 sessions per week. This frequency allows for adequate recovery between sessions while providing enough stimulus to improve fitness over time. Mode and intensity of exercise will adjust monthly.</i_keyword>
      <i_keyword>Control group: conventional therapy along with verbal advice about the cardiovascular and arthritis related benefits of exercise for the same period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resistance training. Timepoint: Pre post treatment. Method of measurement: 6 minutes walk test,spirometry, blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inflammatory markers. Timepoint: Pre post treatment. Method of measurement: Blood Test ( Complete Blood Count).</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>Riphah international university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-15</approval_date>
        <contact_name>Riphah College of rehabilitation &amp; Allied health sciences</contact_name>
        <contact_address>25 Raza Saeed Rd, Bhabra block M Gulberg III, Lahore. Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
