<?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>IRCT20230718058826N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-03</date_registration>
      <primary_sponsor>CUVAS</primary_sponsor>
      <public_title>Assessing the effect of   aerobic exercises on cardiorespiratory and cardiometabolic fitness in hyperlipidemic young population of Multan</public_title>
      <acronym>cross sectional experimental study</acronym>
      <scientific_title>Assessing the effect of aerobic exercises on cardiorespiratory and cardiometabolic fitness in hyperlipidemic young population of Multan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>393</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71393</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research, Other design features: Randomized control trial will be used in this study. We will  randomly allocate the patients into 3 different interventional groups. Each group contain 131 participants, Randomization description: we are studying randomized   control trial   allocation done by lottery method in which 393 patients or participants divided into 3 groups randomly with 131 participants each in each group, Blinding description: in this study, triple blinding method involved in which the participants, investigator and data analyzer will be blinded. Participant do not know about exercise,  investigator  randomly allocate the patient or participants and data analyzer will be independent for results.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>cardiometabolic and cardiorespiratory fitness health in young adults of Multan with hyperlipidemia.</hc_freetext>
      <i_freetext>Intervention 1: 'Intervention group' 1 with jogging .Drink 1 glass of water every hour until you run so you are hydrated. Start with 5 mins of exercise in start and then build up at least 10 mins per session. The goal will be to achieve at least 65-70 mins of jogging per week. Make sure you warm and stretch thoroughly before the exercise. Heart rate , blood pressure, respiration rate, oxygen saturation and temperature will be recorded before and after the exercise. (21). Intervention 2: Intervention group:  ‘Internationale group 2’ with brisk walking .This analysis will be done in young overweight/obese people who completed either the brisk walking program or the brisk walking plus diet program. The brisk walking consisted of walking for 5 to 10 minutes per session and for 3 to 6 days/week. The diet consisted of 60 minutes of group education and 15 to 20 minutes of individual counselings every week. Heart rate, respiration rate ,blood pressure, oxygen saturation and temperature will be recorded before and after the exercise. (22). Intervention 3: Intervention group:  ‘Intervention group 3’ with jumping rope. Exercise intervention will be designed as individualised rope skipping 20 per session and three times a week. The participants will be instructed to gradually increase the amount of rope skipping to 150 per week and then they maintain this exercise intensity until the end of the intervention. Heart rate ,respiration rate, blood pressure ,oxygen saturation and temperature will be recorded before and after the  exercise. (23).</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 correlation of (blood pressure, pulse rate, oxygen saturation, glucose level, lipid profile, temperature and respiration rate) and to improve the quality of life in young adults of Multan with hyperlipidemia that are associated with body mass index and cardiorespiratory and cardiometabolic health.
1.6.	   Expected outcomes
This study will investigate the correlation of cardiorespiratory and cardiometabolic fitness with body mass index in young adults of Multan with hyperlipidemia. We will expect a positive result with blood pressure, heart rate, respiration rate, temperature and oxygen saturation and negative result with VO2max and cholesterol level.

When:
after practical completion

To whom:
investigator

Conditions:
under ethical consideration

Where to obtain:
secretary BASR

How to obtain:
supervisor

Comments:
kindly consider 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>•	Young Adults.•
Age group of 18-30 years
Hyperlipidemic people.•
.•	 Mentally and physically wellbeing.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Older Adults.•
Childs.•
Pregnant Women.•
Uncontrolled hypertension.•
Chronic heart problems.•
Physically disable.•
Mentally ill.•
Any type of major surgery.•
Lactating females.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E00-E89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endocrine, nutritional and metabolic diseases</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 jogging .Drink 1 glass of water every hour until you run so you are hydrated. Start with 5 mins of exercise in start and then build up at least 10 mins per session. The goal will be to achieve at least 65-70 mins of jogging per week. Make sure you warm and stretch thoroughly before the exercise. Heart rate , blood pressure, respiration rate, oxygen saturation and temperature will be recorded before and after the exercise. (21)</i_keyword>
      <i_keyword>Intervention group:  ‘Internationale group 2’ with brisk walking .This analysis will be done in young overweight/obese people who completed either the brisk walking program or the brisk walking plus diet program. The brisk walking consisted of walking for 5 to 10 minutes per session and for 3 to 6 days/week. The diet consisted of 60 minutes of group education and 15 to 20 minutes of individual counselings every week. Heart rate, respiration rate ,blood pressure, oxygen saturation and temperature will be recorded before and after the exercise. (22)</i_keyword>
      <i_keyword>Intervention group:  ‘Intervention group 3’ with jumping rope. Exercise intervention will be designed as individualised rope skipping 20 per session and three times a week. The participants will be instructed to gradually increase the amount of rope skipping to 150 per week and then they maintain this exercise intensity until the end of the intervention. Heart rate ,respiration rate, blood pressure ,oxygen saturation and temperature will be recorded before and after the  exercise. (23)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease cholestrol level and improve the cardiorespiratory health. Timepoint: Time duration of study will be 8 weeks .5 days a week for 8 weeks. Method of measurement: digital sphygmomonometer, thermometer, pulse oximeter, lab kit to measure blood glucose, cholesterol and uric acid.</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>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>
