xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032806</url>
    </required_header>
    <id_info>
      <org_study_id>Tanzeela Rehman 41008</org_study_id>
      <nct_id>NCT06032806</nct_id>
    </id_info>
    <brief_title>Effects of 8 Weeks Moderate and High Intensity Training on Hemoglobin Levels of Female Students</brief_title>
    <official_title>Effects of 8 Weeks Moderate and High Intensity Training on Hemoglobin Levels of Female Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aimed to assess the effectiveness of 8 weeks of moderate and high intensity&#xD;
        training on hemoglobin levels of female students&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Anemia is a global health problem and occurs at all stages of the life cycle but is more&#xD;
        prevalent among 50% young females of reproductive age and 21% of age group 9-29 years, faces&#xD;
        the same problem in Punjab, a province of Pakistan. Higher percentage was found in&#xD;
        hostilities (39.2%) as compared to day scholars (23.1%). Anemia has been shown affect to&#xD;
        mental development and learning capacity, stress level, may cause irritability, fatigue,&#xD;
        difficulty with concentration, lethargy, weakness, and increased susceptibility to infection.&#xD;
        Consequently, anemic patients may tend to be poor in quality of life (1).&#xD;
  &#xD;
        Adult men and adult women have different hemoglobin levels in health. This difference is&#xD;
        independent of iron status - iron replete pre-menopausal women have mean hemoglobin levels&#xD;
        approximately 12% lower than age &amp; race matched men. (2) National Health and Nutrition&#xD;
        Examination Survey (NHANES HI) showed that 9% to11% of adolescent girls and women of&#xD;
        child-bearing age were iron-deficient and 2% to5% of them were diagnosed with iron deficiency&#xD;
        anemia. Iron deficiency with the presence of low hemoglobin is the criterion for the&#xD;
        diagnosis of iron deficiency anemia.(3) There have been frequent reports of a sub-optimal&#xD;
        hematological status being observed in athletes involved in intensive physical activity (4)&#xD;
        Physical activity especially moderate and high intensity reduce mortality and prevent many&#xD;
        chronic diseases such as hypertension, diabetes, stroke, and cancer, and stimulate&#xD;
        erythropoiesis, which can promote healthy cognitive and psycho-social function and increased&#xD;
        hemoglobin concentration Hb lead to increase maximum oxygen carrying capacity (5) A study&#xD;
        reported that aerobic exercise increased hemoglobin (Hb) concentration and hematologic&#xD;
        factors in young females(6,7).&#xD;
  &#xD;
        Recently, the rising prevalence of physical inactivity worldwide has become a major public&#xD;
        health concern, and more than one in four adults fail to follow the minimum recommended&#xD;
        levels of participating in 150 min of moderate physical activity (MPA) per week .(8) This is&#xD;
        because the network or cell will need more oxygen when doing activities so that there is&#xD;
        adaptation in binding oxygen in the blood.(9) But another study conducted on sedentary women&#xD;
        suggest that exercise reduce the red blood cells (RBC), hemoglobin (Hb), and hematocrit (Hct)&#xD;
        in sedentary women.(10) Recently, the prevalence and popularity of high intensity interval&#xD;
        exercise (HIIE) among young adults has provided an exciting type of exercise and health&#xD;
        promotion intervention. High-intensity interval training (HIT) consisting of short bouts of&#xD;
        vigorous intensity exercise, interspersed with low-intensity recovery periods, seems to be&#xD;
        the most effective method to improve exercise performance not only in well-trained athletes&#xD;
        but also in sedentary and diseased individuals. (11) Literature shows that there isn't any&#xD;
        defined physical activity, which can affect the Hb concentration. Currently no study was&#xD;
        found in Pakistan regarding effectiveness of Physical activity on Hemoglobin concentration in&#xD;
        young female. Internationally there is also conflicting result about the effect of exercise&#xD;
        in increasing or decreasing Hb level.(12). The authors conclude that both high and moderate&#xD;
        intensity exercises can improve HB levels in female students. They suggest that the benefits&#xD;
        of exercise on HB concentration appear to be more pronounced in those with lower baseline HB&#xD;
        levels. (13) Most of the literature showed that level of physical activity is associated with&#xD;
        Hb level. But there is paucity in the literature regarding the cause-and-effect relationship&#xD;
        of PA and Hb and any defined physical activity, which can affect the Hb concentration in&#xD;
        young female. So objective of the current study is to determine and compare the effectiveness&#xD;
        of moderate and vigorous physical activity improving hemoglobin concentration in young&#xD;
        female.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>hemoglobin (Hb) level improvement</measure>
      <time_frame>8 weeks</time_frame>
      <description>Changes from the baseline will be measured The amount of hemoglobin in whole blood is expressed in grams per deciliter (g/dl). The normal Hb level for males is 14 to 18 g/dl; that for females is 12 to 16 g/dl.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CBC (Complete blood count)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Changes from the baseline will be measured The CBC test identifies and counts the 7 types of cells found in the blood, red blood cell, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and platelet.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulse oximeter for Heart Rate</measure>
      <time_frame>8 weeks</time_frame>
      <description>Pulse oximeters are often used for estimating heart rate at rest and during exercise.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Moderate and High Intensity Training and Hemoglobin Levels</condition>
    <arm_group>
      <arm_group_label>Group A (Moderate Intensity)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Warm up protocol to reach max HR 50% than moderate intensity exercise. Group A will be given moderate intensity exercise i.e Brisk walk (HR will be in between 50-60% of max HR) .</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B (High Intensity)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Warm up protocol achieve 70% of max HR. Group B will be given high intensity exercise i.e Skipping rope (HR will be in between 70-85% of max HR).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>moderate intensity</intervention_name>
      <description>Arm circles&#xD;
  Leg swings&#xD;
  Lunges</description>
      <arm_group_label>Group A (Moderate Intensity)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>High intensity</intervention_name>
      <description>Arm circles&#xD;
  Leg swings&#xD;
  Lunges&#xD;
  Butt kicks</description>
      <arm_group_label>Group B (High Intensity)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18-25 years.&#xD;
  &#xD;
            -  Hb levels greater than 10 &amp; less than 12.0 gm/dl&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Female staff of the institute.&#xD;
  &#xD;
            -  Students already engaged in physical activity.&#xD;
  &#xD;
            -  Hb levels greater than 12.0 &amp; less than 10 gm/dl&#xD;
  &#xD;
            -  Female having any bony deformity (spine, hip, knee &amp; ankle)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>23 Years</minimum_age>
      <maximum_age>27 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tanzeela Rehman, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University Islamabad</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Waqar Awan, PhD</last_name>
      <phone>0333534884</phone>
      <email>Waqar.ahmed@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tanzeela Rehman, DPT</last_name>
      <phone>03359084922</phone>
      <email>tanzeelarehman82@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sargodha institute of health sciences</name>
        <address>
          <city>Sargodha</city>
          <state>Punjab</state>
          <zip>40100</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Waqar Ahmed, PhD</last_name>
        <phone>0333-5348846</phone>
        <email>waqar.ahmed@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Tanzeela Rehman, DPT</last_name>
        <phone>03359084922</phone>
        <email>tanzeelarehman82@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Tabinda Kanwal, DPT</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>moderate intensity, anemia, high intensity training, Hemoglobin levels</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032806
  org study id: Tanzeela Rehman 41008
  nct id: NCT06032806
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess the effectiveness of 8 weeks of moderate and high intensity
        training on hemoglobin levels of female students
  Anemia is a global health problem and occurs at all stages of the life cycle but is more
        prevalent among 50% young females of reproductive age and 21% of age group 9-29 years, faces
        the same problem in Punjab, a province of Pakistan. Higher percentage was found in
        hostilities (39.2%) as compared to day scholars (23.1%). Anemia has been shown affect to
        mental development and learning capacity, stress level, may cause irritability, fatigue,
        difficulty with concentration, lethargy, weakness, and increased susceptibility to infection.
        Consequently, anemic patients may tend to be poor in quality of life (1).
  
        Adult men and adult women have different hemoglobin levels in health. This difference is
        independent of iron status - iron replete pre-menopausal women have mean hemoglobin levels
        approximately 12% lower than age & race matched men. (2) National Health and Nutrition
        Examination Survey (NHANES HI) showed that 9% to11% of adolescent girls and women of
        child-bearing age were iron-deficient and 2% to5% of them were diagnosed with iron deficiency
        anemia. Iron deficiency with the presence of low hemoglobin is the criterion for the
        diagnosis of iron deficiency anemia.(3) There have been frequent reports of a sub-optimal
        hematological status being observed in athletes involved in intensive physical activity (4)
        Physical activity especially moderate and high intensity reduce mortality and prevent many
        chronic diseases such as hypertension, diabetes, stroke, and cancer, and stimulate
        erythropoiesis, which can promote healthy cognitive and psycho-social function and increased
        hemoglobin concentration Hb lead to increase maximum oxygen carrying capacity (5) A study
        reported that aerobic exercise increased hemoglobin (Hb) concentration and hematologic
        factors in young females(6,7).
  
        Recently, the rising prevalence of physical inactivity worldwide has become a major public
        health concern, and more than one in four adults fail to follow the minimum recommended
        levels of participating in 150 min of moderate physical activity (MPA) per week .(8) This is
        because the network or cell will need more oxygen when doing activities so that there is
        adaptation in binding oxygen in the blood.(9) But another study conducted on sedentary women
        suggest that exercise reduce the red blood cells (RBC), hemoglobin (Hb), and hematocrit (Hct)
        in sedentary women.(10) Recently, the prevalence and popularity of high intensity interval
        exercise (HIIE) among young adults has provided an exciting type of exercise and health
        promotion intervention. High-intensity interval training (HIT) consisting of short bouts of
        vigorous intensity exercise, interspersed with low-intensity recovery periods, seems to be
        the most effective method to improve exercise performance not only in well-trained athletes
        but also in sedentary and diseased individuals. (11) Literature shows that there isn't any
        defined physical activity, which can affect the Hb concentration. Currently no study was
        found in Pakistan regarding effectiveness of Physical activity on Hemoglobin concentration in
        young female. Internationally there is also conflicting result about the effect of exercise
        in increasing or decreasing Hb level.(12). The authors conclude that both high and moderate
        intensity exercises can improve HB levels in female students. They suggest that the benefits
        of exercise on HB concentration appear to be more pronounced in those with lower baseline HB
        levels. (13) Most of the literature showed that level of physical activity is associated with
        Hb level. But there is paucity in the literature regarding the cause-and-effect relationship
        of PA and Hb and any defined physical activity, which can affect the Hb concentration in
        young female. So objective of the current study is to determine and compare the effectiveness
        of moderate and vigorous physical activity improving hemoglobin concentration in young
        female.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: hemoglobin (Hb) level improvement
  time frame: 8 weeks
  description: Changes from the baseline will be measured The amount of hemoglobin in whole blood is expressed in grams per deciliter (g/dl). The normal Hb level for males is 14 to 18 g/dl; that for females is 12 to 16 g/dl.
  measure: CBC (Complete blood count)
  time frame: 8 weeks
  description: Changes from the baseline will be measured The CBC test identifies and counts the 7 types of cells found in the blood, red blood cell, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and platelet.
  measure: Pulse oximeter for Heart Rate
  time frame: 8 weeks
  description: Pulse oximeters are often used for estimating heart rate at rest and during exercise.
  arm group label: Group A (Moderate Intensity)
  arm group type: Experimental
  description: Warm up protocol to reach max HR 50% than moderate intensity exercise. Group A will be given moderate intensity exercise i.e Brisk walk (HR will be in between 50-60% of max HR) .
  arm group label: Group B (High Intensity)
  arm group type: Experimental
  description: Warm up protocol achieve 70% of max HR. Group B will be given high intensity exercise i.e Skipping rope (HR will be in between 70-85% of max HR).
  intervention type: Other
  intervention name: moderate intensity
  description: Arm circles
  Leg swings
  Lunges
  arm group label: Group A (Moderate Intensity)
  intervention type: Other
  intervention name: High intensity
  description: Arm circles
  Leg swings
  Lunges
  Butt kicks
  arm group label: Group B (High Intensity)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 23 Years
  maximum age: 27 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tanzeela Rehman, DPT
  role: Principal Investigator
  affiliation: Riphah International University Islamabad
  last name: Waqar Awan, PhD
  phone: 0333534884
  email: Waqar.ahmed@riphah.edu.pk
  last name: Tanzeela Rehman, DPT
  phone: 03359084922
  email: tanzeelarehman82@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: No