<?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>IRCT20220906055902N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of exercise and caffeine on health and performance indicators</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of spinning training and caffeine supplementation on lipid profile, body composition and functional fitness of overweight women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Blinding description: The study analyst will not be informed of the nature of the groups and we will identify each group with a number.</study_design>
      <phase>3</phase>
      <hc_freetext>Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Spinning exercise + caffeine; Spinning training will be done by pedaling on special bikes for 8 weeks, 3 sessions a week, with an intensity of 40-85% of the maximum reserve heart rate, 30-40 minutes per session and with a resistance of 50-90 revolutions per minute. In order to comply with the overload principle, the intensity, duration and resistance of the bike will be increased once every two weeks. Caffeine powder at the rate of 5 mg/kg of body weight will be consumed 60 minutes before the start of the activity with a glass of water. Intervention 2: Control group: They will do their normal daily activities and will not practice spinning and consume caffeine or placebo. Intervention 3: Intervention group: Spinning exercise + placebo; This group will perform the same spinning exercise as the Spinning + Caffeine group. But instead of caffeine, they will use capsules containing dextrose in the amount of 5 mg/kg 60 minutes before the activity as a placebo. Intervention 4: intervention group: caffeine; This group will use capsules containing caffeine with a dose of 5 mg/kg along with a glass of water at the same hours and days as the other intervention groups.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9, Daneshjo Ave., Shahrood Town</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614616575</zip>
        <telephone>+98 23 3233 4216</telephone>
        <email>S.rajabi@iau-shahrood.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9, Daneshjo Ave., Shahrood Town</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614616575</zip>
        <telephone>+98 23 3233 4216</telephone>
        <email>S.rajabi@iau-shahrood.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a body mass index between 25 and 35 kg/m2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of cardiovascular respiratory disease, diabetes, pregnancy and breastfeeding
Taking anti-inflammatory drugs and special drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified   - Simple obesity NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Spinning exercise + caffeine; Spinning training will be done by pedaling on special bikes for 8 weeks, 3 sessions a week, with an intensity of 40-85% of the maximum reserve heart rate, 30-40 minutes per session and with a resistance of 50-90 revolutions per minute. In order to comply with the overload principle, the intensity, duration and resistance of the bike will be increased once every two weeks. Caffeine powder at the rate of 5 mg/kg of body weight will be consumed 60 minutes before the start of the activity with a glass of water.</i_keyword>
      <i_keyword>Control group: They will do their normal daily activities and will not practice spinning and consume caffeine or placebo.</i_keyword>
      <i_keyword>Intervention group: Spinning exercise + placebo; This group will perform the same spinning exercise as the Spinning + Caffeine group. But instead of caffeine, they will use capsules containing dextrose in the amount of 5 mg/kg 60 minutes before the activity as a placebo.</i_keyword>
      <i_keyword>intervention group: caffeine; This group will use capsules containing caffeine with a dose of 5 mg/kg along with a glass of water at the same hours and days as the other intervention groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profile (cholesterol, triglyceride, LDL and HDL). Timepoint: Before and after the intervention. Method of measurement: Blood sampling using a diagnostic kit for cholesterol, triglycerides, LDL and HDL.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before and after the intervention. Method of measurement: scales.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before and after the intervention. Method of measurement: The ratio of weight to the square of height.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before and after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Abdominal circumference. Timepoint: Before and after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Before and after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: Before and after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Fat percentage. Timepoint: Before and after the intervention. Method of measurement: Caliper.</sec_outcome>
      <sec_outcome>Upper body strength. Timepoint: Before and after the intervention. Method of measurement: One repetition maximum chest press test.</sec_outcome>
      <sec_outcome>Lower body strength. Timepoint: Before and after the intervention. Method of measurement: One repetition maximum leg press test.</sec_outcome>
      <sec_outcome>Upper body muscular endurance. Timepoint: Before and after the intervention. Method of measurement: 60% of one repetition maximum chest press test, repetitions until exhaustion.</sec_outcome>
      <sec_outcome>Lower body muscular endurance. Timepoint: Before and after the intervention. Method of measurement: 60% one repetition maximum leg press test, repetitions until fatigue.</sec_outcome>
      <sec_outcome>Aerobic power. Timepoint: Before and after the intervention. Method of measurement: Bruce's test.</sec_outcome>
      <sec_outcome>Anaerobic power. Timepoint: Before and after the intervention. Method of measurement: Sargent's jump test.</sec_outcome>
      <sec_outcome>Balance. Timepoint: Before and after the intervention. Method of measurement: One leg standing test.</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>Azad University of Shahrood</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-30</approval_date>
        <contact_name>Ethics Committee of Shahrood Islamic Azad University</contact_name>
        <contact_address>University Boulevard, Khatam Al Anbia Hospital, Faculty of Medical Sciences Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
