<?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>IRCT20250222064811N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-09</date_registration>
      <primary_sponsor>Khyber Medical University</primary_sponsor>
      <public_title>Comparing Walking Exercises to Improve Blood Sugar Control in Type 2 Diabetes Patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Immediate Effect of Flat Treadmill Walking with Soleus Pushups versus Inclined Treadmill Walking on Glucose Levels in Type 2 Diabetes Patients: A Randomized Controlled Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of Randomization: Simple randomization using a lottery method.

Unit of Randomization: Individual participants.

Randomization Strata: No stratification is used in this study.

Tools Used in Randomization: A lottery draw is used to generate the random sequence.

How the Random Sequence Was Built: The random sequence is generated through a lottery draw, where participants randomly select their group assignment.

Allocation Concealment: Allocation concealment is not explicitly implemented, as participants are aware of their group assignment immediately after the lottery draw. However, the lottery method ensures that the sequence is unpredictable until the participant makes their selection.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Flat treadmill walking with soleus pushups. Intervention 2: Intervention group: inclined treadmill walk.</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:
COMPARISON OF THE IMMEDIATE EFFECT OF FLAT TREADMILL WALKING WITH SOLEUS PUSHUPS VERSUS INCLINED TREADMILL WALKING ON GLUCOSE LEVELS IN TYPE 2 DIABETES PATIENTS: A RANDOMIZED CONTROLLED TRIAL.
Additional Details: This dataset includes deidentified participant data collected during the study, specifically focusing on blood glucose levels before and after exercise interventions. The shared data will include demographic information, exercise type (flat treadmill walking with soleus pushups or inclined treadmill walking), and corresponding glucose measurements.

When:
After data collection and analysis it will be provided which will probably take 6 months.

To whom:
Deidentified individual participant data (IPD) and supporting documents will be available to researchers from academic institutions, research organizations, and other entities upon request. Access will be granted for the purpose of scientific research and analysis, subject to approval by the study's principal investigator and adherence to ethical guidelines. The data will be shared through a secure platform, ensuring confidentiality and compliance with data protection regulations.

Conditions:
Deidentified IPD will be shared for scientific research related to the study's objectives. Requests must be made in writing, specifying intended use. The principal investigator will review requests based on scientific merit, relevance, and adherence to ethical guidelines.

Where to obtain:
Applicants can obtain the data/documents by contacting the principal investigator, Rabia Qubais, via email at rqubais4@gmail.com. Requests should include a brief description of the intended use of the data.

How to obtain:
Initial Contact: Applicants should contact the principal investigator, Rabia Qubais, via email at rqubais4@gmail.com to express interest in accessing the data/documents.

Application Submission: A formal request must be submitted, including a detailed description of the intended use of the data and how it aligns with the study's objectives.

Review Process: The request will be reviewed by the principal investigator and relevant stakeholders to ensure alignment with ethical guidelines and study objectives.

Approval: Once approved, the applicant will receive instructions on how to access the data/documents securely.

Timeline: The review process typically takes 2-4 weeks, depending on the complexity of the request and the availability of the review committee.

Communication: Applicants will be notified via email regarding the status of their request. If additional information is required, they will be contacted promptly.

Comments:
No additional comments at this time. For any further inquiries or clarification regarding the study or data sharing, please contact the principal investigator via the provided contact information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rabia Qubais</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no.57, street 5, sector k-6, phase 3, Hayatabad Peshawar, Pakistan.</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 332 9993006</telephone>
        <email>rqubais4@gmail.com</email>
        <affiliation>Khyber Medical University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rabia Qubais</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no.57, street 5, sector k-6, phase 3, Hayatabad Peshawar, Pakistan.</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 332 9993006</telephone>
        <email>rqubais4@gmail.com</email>
        <affiliation>Khyber Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Able to complete Physical activity readiness questionnaire
Age 18 years and above
Persons diagnosed with type 2 diabetes for at least a year
Ambulatory (with or without assistive device)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>recently started a new treatment including medication or changed treatment
history of surgery of spine or lower extremity
comorbid conditions that may influence understanding, or answering of the questionnaires (e.g., cognitive impairments).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Type 2 dia</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>E11</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Flat treadmill walking with soleus pushups.</i_keyword>
      <i_keyword>Intervention group: inclined treadmill walk</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood glucose level. Timepoint: immediately after intervention. Method of measurement: glucometer.</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>Khyber Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-05</approval_date>
        <contact_name>Ethics committee of Khyber Medical university</contact_name>
        <contact_address>phase 5, Hayatabad Peshawar Peshawar Khyber Pakhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
