<?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>IRCT20220713055466N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-18</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of tai chi exercise and walking on HbA1C levels health related quality of life in patient with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of tai chi exercise and walking on HbA1C levels health related quality of life in patient with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64786</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation by block method will be in order for the researcher to make sure that exactly the same number of patients will enter the intervention and control groups in a consecutive, but equal, time interval. The groups will be formed as B, A and C. Before assigning people to one of the groups, a list of these letters (B, A, and C), in other words, blocks of sizes 3, 9, and 12, will be created by the reliable website https://www.sealedenvelope.com. Each of the referring and qualified people will be assigned to one of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patient with type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: tai chi exercise: This exercise is performed for 12 weeks (1 to 2 hours after eating). Subjects will participate in two 60-minute Tai Chi training sessions per week for 12 weeks. Each session will include 10 minutes of warm-up, 40 minutes of tai chi and 10 minutes of cooling down. warm up includes; Exercise major joints and muscle groups at a low intensity level to prepare the skeletal muscles, heart and lungs for a gradual increase in exercise intensity following the recommendation of the American Diabetes Association. During each session, in addition to gentle, coordinated and smooth movements of different body parts, relaxation and deep breathing will be emphasized during the exercise. A tai chi workout will be followed by a cool-down workout that is structured like a warm-up to gradually lower the heart rate to pre-exercise levels. Because tai chi involves significant footwork, participants are advised to take precautions to prevent blisters and keep feet dry to minimize foot injury, as recommended by the American Diabetes Association. Recommends. Participants will also be reminded to drink enough water before, during and after exercise, as dehydration can negatively affect blood glucose levels and heart function. To prevent dehydration due to the heat caused by the activity, the gym will have air conditioning. Also, precautions such as eating a snack before exercise will be taken to prevent hypoglycemia caused by exercise. Participants will be advised to notice and report symptoms such as hunger, nervousness, tremors, or sweating. Glucose tablets, juice, soft drinks will be provided to increase blood glucose if needed. In addition, brochures and educational CDs will be given. Intervention 2: Intervention group 2: walking: This exercise is performed for 12 weeks (1 to 2 hours after eating). Each session will include 10 minutes of warm-up and 10 minutes of cool-down. warm up includes; Exercise major joints and muscle groups at a low intensity level to prepare the skeletal muscles, heart and lungs for a gradual increase in exercise intensity following the recommendation of the American Diabetes Association. Participants will be reminded to drink enough water before, during and after exercise, as dehydration can negatively affect blood glucose levels and heart function. To prevent dehydration due to the heat caused by the activity, the gym will have air conditioning. Also, precautions such as eating a snack before exercise will be taken to prevent hypoglycemia caused by exercise. Participants will be advised to notice and report symptoms such as hunger, nervousness, tremors, or sweating. Glucose tablets, juice, soft drinks will be provided to increase blood glucose if needed. In addition, the relevant brochure will be given. Intervention 3: Control group: Non-intervention: This training group will not be given.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Layeghi Motlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 51, Shahid 1 Alley., 30 meters from Maad Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591719154</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>maryam.layeghi93@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Layeghi Motlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 51, Shahid 1 Alley., 30 meters from Maad Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran</address>
        <city>یاسوج</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591719154</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>maryam.layeghi93@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having type 2 diabetes with the approval of a specialist doctor
Treated with oral diabetes medications
Willingness to participate in the study
Awareness of your illness
being alert
Not suffering from mental retardation and not suffering from mental illness
Age 20-60 years
Obtaining an average and unfavorable quality of life score related to health based on a questionnaire</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hospitalization during the study
Creating emergency conditions such as non-ketonic hyperosmolar or hypoglycemia
Patients with decreased visual activity due to diabetic retinopathy and decreased body movement due to diabetic foot disease
Unwillingness to continue cooperation
Migration
Exercise intolerance
Diabetic foot ulcer
Suffering from musculoskeletal or cardiovascular diseases
Lack of regular participation in exercises
Diabetic patients with hemoglobinopathy or anemia
Diabetic patients with uremia
Diabetic patients with microvascular complications such as retinopathy, nephropathy and neuropathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: tai chi exercise: This exercise is performed for 12 weeks (1 to 2 hours after eating). Subjects will participate in two 60-minute Tai Chi training sessions per week for 12 weeks. Each session will include 10 minutes of warm-up, 40 minutes of tai chi and 10 minutes of cooling down. warm up includes; Exercise major joints and muscle groups at a low intensity level to prepare the skeletal muscles, heart and lungs for a gradual increase in exercise intensity following the recommendation of the American Diabetes Association. During each session, in addition to gentle, coordinated and smooth movements of different body parts, relaxation and deep breathing will be emphasized during the exercise. A tai chi workout will be followed by a cool-down workout that is structured like a warm-up to gradually lower the heart rate to pre-exercise levels. Because tai chi involves significant footwork, participants are advised to take precautions to prevent blisters and keep feet dry to minimize foot injury, as recommended by the American Diabetes Association. Recommends. Participants will also be reminded to drink enough water before, during and after exercise, as dehydration can negatively affect blood glucose levels and heart function. To prevent dehydration due to the heat caused by the activity, the gym will have air conditioning. Also, precautions such as eating a snack before exercise will be taken to prevent hypoglycemia caused by exercise. Participants will be advised to notice and report symptoms such as hunger, nervousness, tremors, or sweating. Glucose tablets, juice, soft drinks will be provided to increase blood glucose if needed. In addition, brochures and educational CDs will be given.</i_keyword>
      <i_keyword>Intervention group 2: walking: This exercise is performed for 12 weeks (1 to 2 hours after eating). Each session will include 10 minutes of warm-up and 10 minutes of cool-down. warm up includes; Exercise major joints and muscle groups at a low intensity level to prepare the skeletal muscles, heart and lungs for a gradual increase in exercise intensity following the recommendation of the American Diabetes Association. Participants will be reminded to drink enough water before, during and after exercise, as dehydration can negatively affect blood glucose levels and heart function. To prevent dehydration due to the heat caused by the activity, the gym will have air conditioning. Also, precautions such as eating a snack before exercise will be taken to prevent hypoglycemia caused by exercise. Participants will be advised to notice and report symptoms such as hunger, nervousness, tremors, or sweating. Glucose tablets, juice, soft drinks will be provided to increase blood glucose if needed. In addition, the relevant brochure will be given.</i_keyword>
      <i_keyword>Control group: Non-intervention: This training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemoglobin A1C. Timepoint: Hemoglobin A1C level of patients at the beginning of the study (before the intervention) and 12 weeks after the study. Method of measurement: Analysis with HPLC model DS5.</prim_outcome>
      <prim_outcome>Health related quality of life. Timepoint: The level of Health related quality of life of patients at the beginning of the study (before the intervention) and 12 weeks after the study. Method of measurement: Diabetes Quality of Life-Brief Clinical Inventory.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-18</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
