<?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>IRCT20220603055065N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-22</date_registration>
      <primary_sponsor>Muhammad Institute of Medical and Allied Sciences, Multan</primary_sponsor>
      <public_title>Effects of massage therapy with and without aerobic exercises on glucose, blood pressure and diabetic peripheral neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Effects of massage therapy with and without aerobic exercises on  glucose, blood pressure and diabetic peripheral neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64125</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients will be included in this study by filling questionnaire about diabetes, Randomization description: Patients simply randomized into two groups by using convenient sampling technique. Patients will be randomized by lottery method (Draw numbers from the box randomly to choose samples), Blinding description: Data analyzer will be blinded when analyze the data that which group has which outcome. So, data analyzer will be completely blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic peripheral neuropathic patients.</hc_freetext>
      <i_freetext>Intervention 1: Treatment group: Patients of treatment group receive massage therapy with aerobic exercises. After taking consent from patients they will be assess by using questionnaire for diabetes, pin-prick testing, neuropathy pain scale will be used to check pain, and blood pressure will be monitor by sphygmomanometer and stethoscope. Glucose level will be checked by glucometer. Aerobic exercises include 4-minute walking on electronic treadmill and 6-minute cycling on stationary bicycle. Session lasted for four days per week for six weeks. Glucose level, blood pressure and neuropathic pain will be measured before and after treatment sessions. Intervention 2: Control group: Patients of control group receive massage therapy alone. After taking consent from patients they will be assess by using questionnaire for diabetes, pin-prick testing, neuropathy pain scale will be used to check pain, and blood pressure will be monitor by sphygmomanometer and stethoscope. Glucose level will be checked by glucometer.  Glucose level, blood pressure and neuropathic pain will be measured before and after treatment sessions.Treatment session lasted for four days per week for six weeks.</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:
Title of my study effects of massage therapy with and without aerobic exercises on glucose, blood pressure and diabetic peripheral neuropathy. The basic purpose of my study is to assess the effects of massage therapy with aerobic exercises on diabetic peripheral neuropathic patients. A randomized controoled trial will be cinducted at Muhammad physical therapy clinic and rehabilitation center Multan. 94 subjects will be selected who met the inclusion criteria will be randomized into two groups, tratement group(1) and control group(2). Sampling technique is Convenient. Group 1 receive massage therapy with aerobic exercises(cycling and walking) and group 2 receive massage therapy alone.

When:
This expected that this study or data will be available at the end of this year 2022, no exact date can be expected.

To whom:
Nimra Arif

Conditions:
For research purposes

Where to obtain:
hhttps://www.researchgate.net.https://scholar.google.com hafizairambatool@gmail.com

How to obtain:
Open assess

Comments:
I want randomized controlled trail registration, please provide me as soon as possible, so that I can continue my study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Nimra Arif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL, street near sabzazar metro station, bosan road Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 333 3877032</telephone>
        <email>angelnimra95@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street, near sabzazar metro station, Bosan road Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 304 0134576</telephone>
        <email>imranahmadkhandurrani@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetic peripheral neuropathy patients
Hypertension</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Stroke
Myocardial infarction
Any fracture
Foot ulcer
Unstable heart disease
Acute illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition neuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment group: Patients of treatment group receive massage therapy with aerobic exercises. After taking consent from patients they will be assess by using questionnaire for diabetes, pin-prick testing, neuropathy pain scale will be used to check pain, and blood pressure will be monitor by sphygmomanometer and stethoscope. Glucose level will be checked by glucometer. Aerobic exercises include 4-minute walking on electronic treadmill and 6-minute cycling on stationary bicycle. Session lasted for four days per week for six weeks. Glucose level, blood pressure and neuropathic pain will be measured before and after treatment sessions.</i_keyword>
      <i_keyword>Control group: Patients of control group receive massage therapy alone. After taking consent from patients they will be assess by using questionnaire for diabetes, pin-prick testing, neuropathy pain scale will be used to check pain, and blood pressure will be monitor by sphygmomanometer and stethoscope. Glucose level will be checked by glucometer.  Glucose level, blood pressure and neuropathic pain will be measured before and after treatment sessions.Treatment session lasted for four days per week for six weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diabetic peripheral neuropathy. Timepoint: Patients will be evaluate before and after treatment seesion. Method of measurement: Sphygmomanometer, Stethoscope, Glucometer, Neuropathy pain scale (NPS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after treatment. Method of measurement: With the help of sphygmomanometer and stethoscope for blood pressure and neuropathy pain scale for neuropathic pain.</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>Muhammad Institute of Medical and Allied Sciences, Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-10</approval_date>
        <contact_name>Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan.</contact_name>
        <contact_address>HBL street, near sabzazar ,etro station, bosan road Multan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
