<?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>IRCT20190908044722N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-17</date_registration>
      <primary_sponsor>University of Zululand,</primary_sponsor>
      <public_title>Effects of aerobic dance exercise intensity on body composition, cholesterol, glucose, and cardiovascular fitness in sedentary rural obese black African women</public_title>
      <acronym></acronym>
      <scientific_title>Effects of aerobic dance exercise intensity on body composition, cholesterol, glucose, and cardiovascular fitness in sedentary rural obese black African women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77835</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants were randomised using Random Allocation Software (version 1.0.0) by entering participant details, specifying the randomisation parameters (matching by age and body fat percentage, and assignment to one of 3 groups namely; high-intensity group, moderate-intensity group, and non-exercising control group), and then clicking the "Generate Random Allocation" button to assign participants to different groups randomly, Blinding description: This study was a blind single in that the evaluators did not know which patient was in the intervention group and which was in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Non-exercising control group advised to continue their usual daily routines. Intervention 2: Intervention group:The HIG programmes consisted of supervised aerobic dance sessions performed in the afternoon, three times weekly for eight weeks [23]. All sessions were preceded by a standardised five minute warm-up and concluded with a standardised five minute cooldown [23]. Exercise intensity was monitored continuously as heart rate (HR) using telemetry (Polar Accurex Plus Monitor, Polar Electro Oy, FIN-90440 Kempele, Finland) to ensure workload and the achievement of target heart rate. The HIG performed theirs at 76-95% HRmax for 30 minutes. An experienced Black African dance instructor led each dance session to local and international Black African music. Non-exercising control group participants were instructed to maintain their normal daily activities and dietary practices throughout the experimental period and were phoned three times weekly to ensure compliance. Intervention 3: Intervention group: The MIG programme consisted of supervised aerobic dance sessions performed in the afternoon, three times weekly for eight weeks. All sessions were preceded by a standardised five minute warm-up and concluded with a standardised five minute cooldown. Exercise intensity was monitored continuously as heart rate (HR) using telemetry (Polar Accurex Plus Monitor, Polar Electro Oy, FIN-90440 Kempele, Finland) to ensure workload and the achievement of target heart rate. The MIG participants performed their programme at 60-75% of heart rate maximum (HRmax) for 60 minutes. An experienced Black African dance instructor led each dance session to local and international Black African music. Non-exercising control group participants were instructed to maintain their normal daily activities and dietary practices throughout the experimental period and were phoned three times weekly to ensure compliance.</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:
The analysis of information obtained from the results of the interventions onPrimary outcomes can be published

When:
From the time the article was published until a year later

To whom:
All researchers

Conditions:
Provided Someone wants to do a similar research project

Where to obtain:
r.khanmohamadi65@yahoo.com

How to obtain:
Send request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Musa Lewis Mathunjwaa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 Main Road Vulindlela, kwadlangezwa, Empangeni, South Africa</address>
        <city>Kwadlangezwa</city>
        <country1>South Africa</country1>
        <zip>3886</zip>
        <telephone>+27 73 895 5897</telephone>
        <email>MathunjwaM@unizulu.ac.za</email>
        <affiliation>University of Zululand,</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Musa Lewis Mathunjwaa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Main Road  Vulindlela,  kwadlangezwa, Empangeni, South Africa</address>
        <city>Kwadlangezwa</city>
        <country1>South Africa</country1>
        <zip>3886</zip>
        <telephone>+27 73 895 5897</telephone>
        <email>MathunjwaM@unizulu.ac.za</email>
        <affiliation>University of Zululand</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>South Africa</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Black African
female
live in a rural community,
have a BF% of more than 32%, be between the ages of 18 and 25 years
self-report as being sedentary and weight stable for at least six months before the beginning of the intervention, and were not taking any medication or supplements that could enhance their metabolism or alter their fat metabolism</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participants were excluded from participation in this study if they had any relative or absolute contraindication to exercise and/or testing
any systemic condition or disease, physical disability and/or psychosocial distress precluding them from  exercise testing and training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Non-exercising control group advised to continue their usual daily routines.</i_keyword>
      <i_keyword>Intervention group:The HIG programmes consisted of supervised aerobic dance sessions performed in the afternoon, three times weekly for eight weeks [23]. All sessions were preceded by a standardised five minute warm-up and concluded with a standardised five minute cooldown [23]. Exercise intensity was monitored continuously as heart rate (HR) using telemetry (Polar Accurex Plus Monitor, Polar Electro Oy, FIN-90440 Kempele, Finland) to ensure workload and the achievement of target heart rate. The HIG performed theirs at 76-95% HRmax for 30 minutes. An experienced Black African dance instructor led each dance session to local and international Black African music. Non-exercising control group participants were instructed to maintain their normal daily activities and dietary practices throughout the experimental period and were phoned three times weekly to ensure compliance.</i_keyword>
      <i_keyword>Intervention group: The MIG programme consisted of supervised aerobic dance sessions performed in the afternoon, three times weekly for eight weeks. All sessions were preceded by a standardised five minute warm-up and concluded with a standardised five minute cooldown. Exercise intensity was monitored continuously as heart rate (HR) using telemetry (Polar Accurex Plus Monitor, Polar Electro Oy, FIN-90440 Kempele, Finland) to ensure workload and the achievement of target heart rate. The MIG participants performed their programme at 60-75% of heart rate maximum (HRmax) for 60 minutes. An experienced Black African dance instructor led each dance session to local and international Black African music. Non-exercising control group participants were instructed to maintain their normal daily activities and dietary practices throughout the experimental period and were phoned three times weekly to ensure compliance</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body composition. Timepoint: before intervention and at 8 weeks after start of intervention. Method of measurement: Participants were evaluated for body composition as per the International Society for the Advancement of Kinanthropometry (ISAK) guidelines [20]. Body weight was measured and recorded (to the nearest 0.1 kilogramme (kg)) using a digital scale (Jawon, Model IOI-353, Kyungsun City, Korea), while body height was measured (to the nearest 0.5 cm) using a stadiometer (Marsden HM-250P Portable Height Measure, London, UK). Body mass index (BMI) was calculated by dividing the participant’s body mass (kg) by stature squared (m²) and expressed as kilogrammes per square meter (kg.m-2). Waist circumference was measured at the mid-point between the iliac crest and bottom of the ribcage while hip circumference measurement was taken at the widest circumference of buttocks and these two values were used to calculate the waist-to-hip ratio (WHR). Skinfolds of the triceps, subscapular, chest, mid-axillary, suprailiac, abdominal, and thigh were measured to the nearest 0.2 millimetres with a Holtain skinfold calliper (Holtain Ltd Crymych, UK). Body fat percentage (BF%) was calculated using the equation of Jackson and Pollock.</prim_outcome>
      <prim_outcome>Blood total cholesterol,. Timepoint: before intervention and at 8 weeks after start of intervention. Method of measurement: Following a nine to 12-hour overnight period of fasting and 48-hour period of no exercise, blood glucose and total cholesterol (TC) were assessed from capillary blood samples collected through transcutaneous puncture on the medial side of the tip of the middle finger using a disposable hypodermic lancet. Prior to puncture, 70% alcohol was used to promote antisepsis. The first drop of blood was discarded, and the following were used in random order for the analyses using a validated and reliable point-of-care (POC) monitoring device (Accutrend Plus system, Roche Diagnostics, USA). The Accutrend Plus system has previously demonstrated good reproducibility (Lin's coefficient: glucose = 0.958, and TC =  0.940) and high concordance with the laboratory method (Lin's coefficient: glucose = 0.952, and TC = 0.944) and high sensitivity (glucose = 80.0%, and total cholesterol = 84.4%) and specificity (glucose = 100.0%, and total cholesterol = 95.2%).</prim_outcome>
      <prim_outcome>Blood glucose,. Timepoint: before intervention and at 8 weeks after start of intervention. Method of measurement: Following a nine to 12-hour overnight period of fasting and 48-hour period of no exercise, blood glucose and total cholesterol (TC) were assessed from capillary blood samples collected through transcutaneous puncture on the medial side of the tip of the middle finger using a disposable hypodermic lancet. Prior to puncture, 70% alcohol was used to promote antisepsis. The first drop of blood was discarded, and the following were used in random order for the analyses using a validated and reliable point-of-care (POC) monitoring device (Accutrend Plus system, Roche Diagnostics, USA). The Accutrend Plus system has previously demonstrated good reproducibility (Lin's coefficient: glucose = 0.958, and TC =  0.940) and high concordance with the laboratory method (Lin's coefficient: glucose = 0.952, and TC = 0.944) and high sensitivity (glucose = 80.0%, and total cholesterol = 84.4%) and specificity (glucose = 100.0%, and total cholesterol = 95.2%).</prim_outcome>
      <prim_outcome>Cardiovascular fitness. Timepoint: before intervention and at 8 weeks after start of intervention. Method of measurement: Cardiorespiratory fitness (VO2max) was evaluated using the 20-metre shuttle run test [22]. For this test, participants were instructed to run back and forth shuttles between two cones placed 20 metres apart from each other. The pace of participants was controlled by an audible beep on a pre-recorded tape that sounded each time the participant was expected to reach the cone for the completion of a shuttle. The test was automatically cancelled if a participant failed to complete two successive shuttles. VO2max was estimated by retroextrapolating the oxygen recovery curve at time zero of recovery [22].</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>University of Zululand,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-26</approval_date>
        <contact_name>University of Zululand Research Ethics Committee</contact_name>
        <contact_address>Department of Human Movement Science, University of Zululand, Kwadlangezwa, KwaZulu-Natal, South Africa, 3886 Kwadlangezwa KwaZulu-Natal South Africa</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
