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/NCT06020846</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIU Ume Farva</org_study_id>
      <nct_id>NCT06020846</nct_id>
    </id_info>
    <brief_title>Effect of Soleus Pushup Exercise in Type 2 Diabetes Patients</brief_title>
    <official_title>Comparison of the Immediate Effects of Soleus Pushup Exercise and Treadmill Walk on Blood Glucose Levels in Type 2 Diabetes Population.</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>
        The aim of this research is to compare the immediate effects of one hour Soleus Pushup&#xD;
        Exercise and treadmill walk in Type 2 Diabetic population on blood glucose level. Randomized&#xD;
        controlled trials done at Railway General Hospital and diabetic centers of Rawalpindi and&#xD;
        Islamabad.. The sample size was 66. The subjects were divided in two groups, 33 subjects in&#xD;
        Soleus Pushup Exercise group and 33 subjects in treadmill walk group. Study duration was of 6&#xD;
        months. Sampling technique applied was non probability convenience sampling technique. Only&#xD;
        40-60 years diabetic people with clinically diagnosed type 2 Diabetes for upto 10 years were&#xD;
        included. Tools used in the study are Glucometer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Diabetes is on the rise worldwide, with a global prevalence in adults in 2021 being 537&#xD;
        million adults (20-79 years) living with diabetes -one in ten. This number is predicted to&#xD;
        rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in&#xD;
        low- and middle-income countries. Although physical activity (PA) is a key element in the&#xD;
        prevention and management of type 2 diabetes. Structured interventions combining Physical&#xD;
        Activity and modest weight loss have been shown to lower type 2 diabetes risk by up to 58% in&#xD;
        high-risk populations. The increase in T2DM prevalence can only partly be attributed to the&#xD;
        increasing prevalence of obesity and a sedentary lifestyle. The exercise recommendations for&#xD;
        individuals with type 2 diabetes are similar as for the general population, suggesting a&#xD;
        minimum of 150 min of moderate-vigorous-intensity aerobic exercise each week. However, the&#xD;
        general population doesn't adhere to these guidelines.&#xD;
  &#xD;
        The goal of treatment in type 2 diabetes is to achieve and maintain optimal BG, lipid, and&#xD;
        blood pressure (BP) levels to prevent or delay chronic complications of diabetes. A&#xD;
        fundamental principle in exercise physiology is that a small muscle mass working in isolation&#xD;
        can achieve a higher local oxygen consumption (VO2/min per kg) than when recruiting a large&#xD;
        muscle mass. The soleus (1% body mass) has a highly pennated architecture favoring greater&#xD;
        amounts of muscular work during plantarflexion. It has an exceptionally high physiological&#xD;
        cross-sectional area (3-8 times more than most of the 20 other limb muscles studied).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</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>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood glucose level</measure>
      <time_frame>baseline to 30 minutes and 60 minutes</time_frame>
      <description>The blood glucise level will be measured by the glucometer at base line , 30 min and at 60 min</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Soleus Pushup Exercise group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>soleus push up exercise</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treadmill group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>treadmill walk</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Soleus Pushup Exercise</intervention_name>
      <description>Patient will be seated on a chair, his legs at 90 degrees to the floor, keep the toes, and feet flat on the ground, and move his heels up and down continuously.&#xD;
  4 sets of 15 minutes each,1hour total intervention time</description>
      <arm_group_label>Soleus Pushup Exercise group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>treadmill walk group 2</intervention_name>
      <description>The patient will do treadmill walk at normal walking speed, 4 sets of treadmill walk for 15 minutes each, 1hour total intervention time</description>
      <arm_group_label>Treadmill group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Both male and female individuals&#xD;
  &#xD;
                 -  Individuals with age between 40 to 60 years&#xD;
  &#xD;
                 -  Individuals with clinically diagnosed diabetes type 2 up to 10 years&#xD;
  &#xD;
                 -  individuals not engaged in a structured walking/exercise program&#xD;
  &#xD;
                 -  2 hours post meal with glucose ranging upto 200.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • No recent or planned changes in diet, physical activity, or medications.&#xD;
  &#xD;
                 -  Participants diagnosed with pre-diabetes, gestational diabetes, or type 1&#xD;
                    diabetes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, PHD</last_name>
      <phone>03324390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Railway General Hospital</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <zip>46000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
        <phone>03015030784</phone>
        <email>aisha.razzaq@riphah.edu.pk</email>
      </contact>
      <investigator>
        <last_name>um Farwa, MSPT-OMPT*</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 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 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diabetes mellitus, type 2</keyword>
    <keyword>soleus push up</keyword>
    <keyword>treadmill walk</keyword>
    <keyword>blood glucose</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <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/NCT06020846
  org study id: RiphahIU Ume Farva
  nct id: NCT06020846
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this research is to compare the immediate effects of one hour Soleus Pushup
        Exercise and treadmill walk in Type 2 Diabetic population on blood glucose level. Randomized
        controlled trials done at Railway General Hospital and diabetic centers of Rawalpindi and
        Islamabad.. The sample size was 66. The subjects were divided in two groups, 33 subjects in
        Soleus Pushup Exercise group and 33 subjects in treadmill walk group. Study duration was of 6
        months. Sampling technique applied was non probability convenience sampling technique. Only
        40-60 years diabetic people with clinically diagnosed type 2 Diabetes for upto 10 years were
        included. Tools used in the study are Glucometer
  Diabetes is on the rise worldwide, with a global prevalence in adults in 2021 being 537
        million adults (20-79 years) living with diabetes -one in ten. This number is predicted to
        rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in
        low- and middle-income countries. Although physical activity (PA) is a key element in the
        prevention and management of type 2 diabetes. Structured interventions combining Physical
        Activity and modest weight loss have been shown to lower type 2 diabetes risk by up to 58% in
        high-risk populations. The increase in T2DM prevalence can only partly be attributed to the
        increasing prevalence of obesity and a sedentary lifestyle. The exercise recommendations for
        individuals with type 2 diabetes are similar as for the general population, suggesting a
        minimum of 150 min of moderate-vigorous-intensity aerobic exercise each week. However, the
        general population doesn't adhere to these guidelines.
  
        The goal of treatment in type 2 diabetes is to achieve and maintain optimal BG, lipid, and
        blood pressure (BP) levels to prevent or delay chronic complications of diabetes. A
        fundamental principle in exercise physiology is that a small muscle mass working in isolation
        can achieve a higher local oxygen consumption (VO2/min per kg) than when recruiting a large
        muscle mass. The soleus (1% body mass) has a highly pennated architecture favoring greater
        amounts of muscular work during plantarflexion. It has an exceptionally high physiological
        cross-sectional area (3-8 times more than most of the 20 other limb muscles studied).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Blood glucose level
  time frame: baseline to 30 minutes and 60 minutes
  description: The blood glucise level will be measured by the glucometer at base line , 30 min and at 60 min
  arm group label: Soleus Pushup Exercise group A
  arm group type: Experimental
  description: soleus push up exercise
  arm group label: Treadmill group 2
  arm group type: Active Comparator
  description: treadmill walk
  intervention type: Other
  intervention name: Soleus Pushup Exercise
  description: Patient will be seated on a chair, his legs at 90 degrees to the floor, keep the toes, and feet flat on the ground, and move his heels up and down continuously.
  4 sets of 15 minutes each,1hour total intervention time
  arm group label: Soleus Pushup Exercise group A
  intervention type: Other
  intervention name: treadmill walk group 2
  description: The patient will do treadmill walk at normal walking speed, 4 sets of treadmill walk for 15 minutes each, 1hour total intervention time
  arm group label: Treadmill group 2
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Aisha Razzaq, MSPT-OMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Imran Amjad, PHD
  phone: 03324390125
  email: imran.amjad@riphah.edu.pk
  facility: 
  contact: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No