<?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>IRCT20200212046468N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-11</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The combined effect of energy storage and hatha yoga strategies on severity of fatigue and psychological well-being in patients with arthritic rheumatism</public_title>
      <acronym></acronym>
      <scientific_title>: The combined effect of energy conservation strategies and Hatha Yoga on the severity of fatigue and psychological well-being of patients with rheumatoid arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45750</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Study samples are randomly selected and available at random. After selection, participants will be randomly assigned to a block between the three groups. Since the estimated sample size was 75 people, so by comparing 20 random numbers generated by Sample Randomizer software, how to arrange 75 research samples and assigning each number from 1 to 75 to one of the specified control and control groups and the block random allocation list.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with rheumatoid arthritis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Hata Yoga: In this group, the intervention will perform selected Hata Yoga exercises for 8 weeks twice a week and each session 45 minutes under the supervision of a qualified trainer. In the initial sessions, the trainer first puts people in Shawasana or dead bodies for 10 minutes and teaches mind control techniques and then 30 minutes of light exercises including 4 sleeping movements, 4 sitting exercises. And there will be 4 movements in the standing posture, and the important point is that after each movement there will be mental attention to the limbs and breathing, in all three positions there will be physical exercises along with breathing and relaxation exercises. Subsequent sessions of training will progress from moderate to moderate and will include a modified training program for at least one or two hours. Eat after breakfast or a light lunch in a yoga mat or at least a quiet place with a soft carpet in a balanced (not cold or warm) atmosphere. Intervention 2: Second Intervention group: energy conservation: In this group, the necessary training will be done for 8 weeks. Session 1- Introduction, introduction, pre-test, session 2- Group training and according to the status of each patient and Prioritize implementation, session 3- Training Group and according to the status of each patient and implementation of the plan, Session 4- Training in group and according to the status of each patient and implementation of pace, Session 5- Training in group and according to the status of each patient and implementation of posture , Session 6- Repeat and Practice Sessions, Session 7- Repeat and Practice Sessions, Session 8- Summary and Taking the Post-Test. Intervention 3: Third Intervention group: The combined of Hata Yoga and energy conservation: In this group, all the interventions mentioned in the previous two groups will be combined.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziyeh Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, Saadi Alley., Rahnamaei Ave, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591977833</zip>
        <telephone>+98 74 3322 6978</telephone>
        <email>marzi.gh1991@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marziyeh Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, Saadi Alley., Rahnamaei Ave, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591977833</zip>
        <telephone>+98 74 3322 6978</telephone>
        <email>marzi.gh1991@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of rheumatoid arthritis by a rheumatologist
Minimum literacy
3. Age range 30 to 55 years.
Having the physical and cognitive ability to participate in Hatha Yoga exercises.
No range of motion in the range of joints.
Personal and informed consent.
The patient should receive the same treatment.
Do not participate in other intervention studies at the same time</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other chronic diseases.
Active phase of the disease and any disease that is prohibited to perform hatha Yoga</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis with rheumatoid factor, unspecified</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>First intervention group: Hata Yoga: In this group, the intervention will perform selected Hata Yoga exercises for 8 weeks twice a week and each session 45 minutes under the supervision of a qualified trainer. In the initial sessions, the trainer first puts people in Shawasana or dead bodies for 10 minutes and teaches mind control techniques and then 30 minutes of light exercises including 4 sleeping movements, 4 sitting exercises. And there will be 4 movements in the standing posture, and the important point is that after each movement there will be mental attention to the limbs and breathing, in all three positions there will be physical exercises along with breathing and relaxation exercises. Subsequent sessions of training will progress from moderate to moderate and will include a modified training program for at least one or two hours. Eat after breakfast or a light lunch in a yoga mat or at least a quiet place with a soft carpet in a balanced (not cold or warm) atmosphere.</i_keyword>
      <i_keyword>Second Intervention group: energy conservation: In this group, the necessary training will be done for 8 weeks. Session 1- Introduction, introduction, pre-test, session 2- Group training and according to the status of each patient and Prioritize implementation, session 3- Training Group and according to the status of each patient and implementation of the plan, Session 4- Training in group and according to the status of each patient and implementation of pace, Session 5- Training in group and according to the status of each patient and implementation of posture , Session 6- Repeat and Practice Sessions, Session 7- Repeat and Practice Sessions, Session 8- Summary and Taking the Post-Test</i_keyword>
      <i_keyword>Third Intervention group: The combined of Hata Yoga and energy conservation: In this group, all the interventions mentioned in the previous two groups will be combined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of fatigue. Timepoint: Fatigue severity at baseline (before intervention) and after baseline. Method of measurement: Multidimensional Fatigue Assessment Inventory (MFI).</prim_outcome>
      <prim_outcome>Psychological well-being. Timepoint: Psychological well-being at baseline (before intervention) and after baseline. Method of measurement: Ryff’s Psychological Well-being questionnaire.</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>2020-01-13</approval_date>
        <contact_name>Ehtics commitee of yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj- Shahid Motahari Boulevard- Yasuj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
