<?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>IRCT20230718058826N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-01</date_registration>
      <primary_sponsor>CUVAS</primary_sponsor>
      <public_title>Assessing the effect of aerobic exercises on cardiorespiratory and cardiometabolic fitness in post menopausal females in Multan</public_title>
      <acronym>cross sectional experimental study</acronym>
      <scientific_title>Assessing the effect of aerobic exercises on cardiorespiratory and cardiometabolic fitness in post menopausal females in Multan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71389</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Allocation is done by the lottery method in which the names of the participants are written on pieces of paper and randomly chosen the paper by an individual and then people are allocated randomly to different groups without knowing which participant is added to which intervention group, Blinding description: in this study, triple blinding method involved in which the participants, investigator and data analyzer will be blinded. Participants randomly allocate in different intervention group and they do not know about exercise in any intervention group ,investigator randomly allocate the patient or participant and data analyzer will be independent for results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cardiorespiratory and cardiometabolic health in post menopausal females age 40-60.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention Group 1": with 6 Minute Walk Test (6MWT)A 30m walking pace will be decided. Subjects will be instructed to walk from end to end, while attempting to cover as much distance as possible in the 6 minutes. The time and distance covered will be recorded. The Borg scales for dyspnea and leg fatigue, as well as heart rate were recorded before and immediately after completion of the walk test(24). BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise. Intervention 2: "Intervention Group 2": with Stair climbing3 bouts of stair climbing will be separated.  In this, protocol will be included 3 daily bouts of ascending a 3-flight stairwell (10 steps) for 4 minutes gently without break. The height of step will be 35cm. This activity will be performed 5days/week for 6 weeks. BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise. Intervention 3: 'Intervention group 3": with Step up exercise3 sets with 10 repetitions in each set will be performed for 6 weeks. BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.</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:
Aim of this study is to explore the correlates(BP, HR, oxygen saturation, glucose level, lipid profile, temperature, RR) of post menopausal females of Multan that are associated with body mass index and cardiorespiratory and cardiometabollic health. Aim of this study is to improve the quality of life.  
1.4.	Expected Outcomes
This study will investigate the correlation of cardiorespiratory fitness and cardiometabolic with body mass index in post menopausal females of Multan and also investigate the respiratory improvements.

When:
After the protocol completion data will be available for long time

To whom:
Supervisor provided the all documents

Conditions:
Under strict ethical consideration

Where to obtain:
from secretary BASR

How to obtain:
IRB form, informed consent for and reports

Comments:
Kindly approve it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahid Manzoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bahawalpur , punjab, Pakistan</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 312 6678543</telephone>
        <email>zahidmanzoor@cuvas.edu.pk</email>
        <affiliation>CUVAS</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Perwasha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street near sabzazar metro station bosan road Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 310 6562039</telephone>
        <email>perwashanaseer123@gmail.com</email>
        <affiliation>MIMAS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Females 40-60
post menopausal females
good mental and physical health
natural menopausal
negative screening mammogram</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>young females
perimenopausal
any type of physical and mental disability, major surgery
females with OP OA
history of melanoma  or breast cancer
hormone replacement therapy patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ICD-10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>post menopausal females, cardiorespiratory fitness</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention Group 1": with 6 Minute Walk Test (6MWT)A 30m walking pace will be decided. Subjects will be instructed to walk from end to end, while attempting to cover as much distance as possible in the 6 minutes. The time and distance covered will be recorded. The Borg scales for dyspnea and leg fatigue, as well as heart rate were recorded before and immediately after completion of the walk test(24). BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.</i_keyword>
      <i_keyword>"Intervention Group 2": with Stair climbing3 bouts of stair climbing will be separated.  In this, protocol will be included 3 daily bouts of ascending a 3-flight stairwell (10 steps) for 4 minutes gently without break. The height of step will be 35cm. This activity will be performed 5days/week for 6 weeks. BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.</i_keyword>
      <i_keyword>'Intervention group 3": with Step up exercise3 sets with 10 repetitions in each set will be performed for 6 weeks. BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve Cardiorespiratory and cardiometabollic health. Timepoint: time duration of study will be six weeks. 5 days in a weak for 6 weeks. Method of measurement: BP, RR, HR, Temperature, Oxygen saturation, glucose level, cholestrol level.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: time duration of study will be 6 weeks. 5 days in a week for 6 weeks. Method of measurement: vo2max,cardiorespiratory parameters.</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>scholarship for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-10</approval_date>
        <contact_name>Ethical Committee of Muhammad Institute of Medical and Allied Sciences</contact_name>
        <contact_address>HBL street near sabzazar metro station bosan road Multan Multan punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
