<?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>IRCT20240430061607N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-06</date_registration>
      <primary_sponsor>Debre Markos University</primary_sponsor>
      <public_title>Impact of Exercise on Metabolism in Overweight/Obese Adults</public_title>
      <acronym></acronym>
      <scientific_title>Metabolic Impact of Exercise Modalities in Inactive Overweight and Obese Adults: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76528</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In our clinical trial, randomization was achieved through simple random sampling, with individuals as the unit of randomization. A computerized random number generator created a sequence to allocate participants to their respective groups, ensuring each had an equal chance of assignment. Allocation concealment was implemented using sealed opaque envelopes, which were opened only after baseline assessments, to prevent selection bias and uphold the study’s integrity, Blinding description: The outcome assessors and data analysts were masked to the group assignments of participants. This was achieved by assigning codes to participant groups that were only known to researchers. The assessors and analysts worked with these codes, devoid of any knowledge regarding which group each code represented. This method effectively prevented potential bias in the assessment of outcomes and the analysis of data, thereby upholding the integrity of the research findings.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: glucose intolerance. Condition 2: dyslipidemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Aerobic exercise training group. Participants in the AT group engaged in treadmill exercise at 50-75% of their maximum heart rate for 25-40 minutes, 3 times per week. Intervention 2: Intervention group 2: resistance Exercise training group. The RT group performed 6 major muscle exercises targeting major muscle groups at 50–75% of their 1-RM, 3 times per week. Intervention 3: Control group: concurrent training group. The CT group combined the total volume of both the RT and AT groups, performing endurance exercises followed by strength exercises in each session.</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 The datasets generated and/or analyzed during the current study are not publicly available due to data security before publication but are available from the corresponding author on reasonable request.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Friew Amare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abima, Debre Markos</address>
        <city>Debre Markos</city>
        <country1>Ethiopia</country1>
        <zip>no</zip>
        <telephone>+251 58 771 6070</telephone>
        <email>firewa6070@gmail.com</email>
        <affiliation>Debre Markos University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yehualaw Alemu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abima, Debre Markos</address>
        <city>Debre Markos</city>
        <country1>Afghanistan</country1>
        <zip>no</zip>
        <telephone>+251 58 771 6070</telephone>
        <email>yehualaw@gmail.com</email>
        <affiliation>Debre Markos University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Ethiopia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Had a BMI &gt; 24.9 kg/m2
Were aged between 45 and 60 years
Volunteered to participate
Were physically inactive (not achieving 30–60 min per day or 150 min per week of moderate intensity exercise or 20–60 min per day (75 min per week) of vigorous intensity and cleared a medical history form the physical activity readiness questionnaire)
Were able to perform the necessary exercises</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any cardiovascular, respiratory, or muscle-skeletal disorders precluding physical exercise
Uncontrolled hyperglycemia (≥ 126 mg/d)
 Uncontrolled hypertension (a resting blood pressure ≥140/100 mm hg)
Active infection
Acute myocardial infarction, stroke, trauma, surgery or severe liver dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Aerobic exercise training group. Participants in the AT group engaged in treadmill exercise at 50-75% of their maximum heart rate for 25-40 minutes, 3 times per week.</i_keyword>
      <i_keyword>Intervention group 2: resistance Exercise training group. The RT group performed 6 major muscle exercises targeting major muscle groups at 50–75% of their 1-RM, 3 times per week.</i_keyword>
      <i_keyword>Control group: concurrent training group. The CT group combined the total volume of both the RT and AT groups, performing endurance exercises followed by strength exercises in each session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glucose tolerance. Timepoint: before intervention and at the end of eighth week. Method of measurement: GOTT tests were analyzed by the hexokinase method (COBAS, Roche), and its intracoefficient of variation ranged between 1.58% (µ=64.7 mg/dl) and 1.38% (µ=369 mg/dl).</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: before intervention and at the end of eighth week. Method of measurement: An enzymatic method utilizing an Alpha X autoanalyzer with E2HL-100 kits and a sensitivity of 0.1 mmol/dL (Hitachi, Tokyo, Japan) was employed for lipid measurement.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: before intervention and at the end of eighth week. Method of measurement: body fat percentage were determine by abdominal, thigh, suprailiac and triceps skinfolds measurements on the right side of the body to the nearest 0.5 mm with a Lange caliper (Cambridge Scientific Instruments, Cambridge, MD, USA). and determined by sari equation.</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>Debre Markos University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-15</approval_date>
        <contact_name>Debre Markos University Sport Science Academy Ethics committee</contact_name>
        <contact_address>Abima, Debre Markos Debre Markos Amhara Ethiopia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
