<?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>IRCT20160802029159N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-26</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Acupressure on Spirometery Indicators and Functional Exercise Capacity</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Acupressure on Spirometry Indicators and Functional Exercise Capacity in people with Chronic Obstructive Pulmonary Disease (COPD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40042</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 120 participants with Chronic Obstructive Pulmonary Disease will be randomly assigned into one of three groups: one intervention group (acupressure), one control group; and one placebo group.
The eligible people will be in the study groups by a randomization process.
The random allocation of this study will be achieved using an online random number generator (randomization.com) following a balanced 1:1 pattern.
The information on the allocation list will remain strictly confidential and sequentially numbered; opaque, sealed envelopes will be used to contain the randomization assignments. 
The Acupressure Specialist will open the envelopes according to the numerical sequence, immediately before the first session of treatment, Blinding description: Patients will remain blinded regarding the category of their allocation throughout the study data collection period. Additionally, the evaluators responsible for the data collection and the outcomes assessor will also be blinded to the patient allocation. The Acupressure Specialist will be the only person not blind to the type of treatment to be performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Obstructive Pulmonary Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 4 points including the point (EX.17)Dingchuan (at 5 cun intervals with the C7 neck neck) (due to the fact that each cun is approximately the same as the width of the thumb), the point (UB.13) Feishu (1 / 5th cun is located next to the T-3 thoracic vertebra), point (UB.23) Shenshu is located 1 / 5th cun along the lumbar vertebra L2) and the point (St.36)  Zusanli (lower than the lower knee joint of the tibia tetanus) and then acupressure (12 sessions) for 3 minutes (a total of 12 minutes), 3 times per week and for 4 weeks. Intervention 2: Control group: In the placebo group, 1.5 centimeters distance from the main acupressure program will be implemented. Intervention 3: Control group: In the control group, routine care will be taken and there will be no intervention.</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:
The data will be shared with the Ethics Committee of the Babil University of Medical Sciences after the analysis in the text of the article and the report of the end of the work.

When:
7 months

To whom:
Only the research team and the Ethics Committee of the Babil University of Medical Sciences have access to raw data.

Conditions:
Increased clinical application of the study results

Where to obtain:
Refer to the administrator and address of Fatemeh Zahra Faculty of Nursing, Ramsar

How to obtain:
The request must be submitted to the administrator's email address and the submitter, after consulting and consulting with the research team, will refer the request to the university's ethics committee and, upon receipt of the approval of the ethics committee, will provide the applicant with the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moloud Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari Ave; Enghelab Square; Ramsar; Mazandaran; Iran</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691857995</zip>
        <telephone>+98 11 5525 8118</telephone>
        <email>m.sharifi@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moloud Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari Ave; Enghelab Square; Ramsar; Mazandaran; Iran</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691857995</zip>
        <telephone>+98 11 5525 8118</telephone>
        <email>m.sharifi@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Full consciousness
Ability to walk independently
Diagnosis of COPD by an internal medicine
Having an FEV1 to FVC ratio of less than 0.7 after bronchodilators
No smoking (cigarettes and hookahs)
Lack of allergies,
Absence of an obstacle to the practice of acupressure
Lack of visual impairment
The ability to get on the prone position
Not having previous experience of acupressure or acupuncture</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exacerbated Chronic Obstructive Pulmonary Disease
Acute Respiratory Disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z82.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Family history of asthma and other chronic lower respiratory diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, 4 points including the point (EX.17)Dingchuan (at 5 cun intervals with the C7 neck neck) (due to the fact that each cun is approximately the same as the width of the thumb), the point (UB.13) Feishu (1 / 5th cun is located next to the T-3 thoracic vertebra), point (UB.23) Shenshu is located 1 / 5th cun along the lumbar vertebra L2) and the point (St.36)  Zusanli (lower than the lower knee joint of the tibia tetanus) and then acupressure (12 sessions) for 3 minutes (a total of 12 minutes), 3 times per week and for 4 weeks.</i_keyword>
      <i_keyword>Control group: In the placebo group, 1.5 centimeters distance from the main acupressure program will be implemented.</i_keyword>
      <i_keyword>Control group: In the control group, routine care will be taken and there will be no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spirometric indices. Timepoint: The spirometric indices are evaluated in three sessions of the first, sixth and twelfth sessions (immediately before the first session, the sixth session and immediately after the 12th session). Method of measurement: Spirometry machine model HI-801.</prim_outcome>
      <prim_outcome>Functional exercise capacity. Timepoint: Functional exercise capacity will be evaluated in three sessions of the first, sixth and twelfth sessions (immediately before the first session, sixth session and immediately after the twelfth meeting). Method of measurement: Six-Minute Walking Practice Test (6MWT): This is a simple test to assess the ability of a person's  performance and can reflect the ability of an individual to operate on a daily basis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dyspnea. Timepoint: Dyspnea will be evaluated in three sessions of the first, sixth and twelfth sessions (immediately before the first meeting, sixth session and immediately after the twelfth meeting). Method of measurement: Dyspnea Visual Analogue Scale.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-10</approval_date>
        <contact_name>Ethics committee of  Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Gangafrooz  Street, Babol, Mazandaran Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
