<?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>IRCT20220107053651N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of online Floor-seated Exercise training on depression, anxiety and stress of older adults during COVID-19 epidemy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of online Floor-seated Exercise training on depression, anxiety and stress of older adults in COVID-19 epidemy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61161</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Quadruple blocking. Explanation of the method: Each sample is assigned a code and these codes are given to a person other than the researcher without the names of the samples and based on randomly assigned block allocation to the volume of 4 blocks (two assignments to the control group and two Assignment to the test group) - in such a way that the letter A will be considered for the test group and the letter B will be considered for the control group. Possible modes in the four blocks of six modes include AABB, BBAA, ABAB, BABA, ABBA, BAAB, each mode will be written on a card and the cards will be assigned the number one to six, then using the dice of the six modes One may be selected and the selected seniors will be divided into two groups based on that. This process will continue until the sample size is completed. block randomization is performed in practice using SAS statistical software. Concealment is done through the SNOSE (Sequentially Numbered, Opaque, Sealed Envelopes) method: based on the size of the research sample, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes), are prepared and each of the random sequences created is recorded on a card and the cards are inside. Letter envelopes are placed in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. At the time of registration, based on the order in which eligible participants enter the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety, stress, depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Forming a WhatsApp group - Sending a link to provide online sessions and explanations about it and a link to the online demographic and DASS-21 questionnaires before the intervention - Completing the questionnaires online through the Pors-Line site by individuals - Providing sitting exercises online Through the Skype application by the sports expert trainer, during 12 weeks, three days a week, each session lasts for 30-45 minutes and the exercises are performed by people at the same time. Exercise with soft music including topics such as flexibility, deep breathing with up and down arm pulling, wrist grip, wrist pressure, knee support, quadriceps muscle training and mind focus - Completion of DASS-21 questionnaire after the last session by Persons. Intervention 2: Control group: Formation of WhatsApp group - Send the link of online demographic and DASS-21 questionnaires before the intervention - Complete the questionnaires online through the Press Line site - Send only 30-45 minute short sports training videos (if you do not send this period) Video time is cut by WhatsApp, videos are sent in several videos of 10-15 minutes in a group.) Three times a week for 12 weeks in a group - Doing exercises in person if they want to (the exercises are not online and they are not supervised by the constructor and they are not mostly seated exercises so some of the participants may have trouble doing them due to their frailty).</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:
All data is potentially shareable after unidentifiable individuals

When:
Access period starts 6 months after the results are published

To whom:
It will be available to researchers working in academic and scientific institutions, or people who are also involved in industry can apply for it.

Conditions:
Data analysis is allowed for scientific and statistical review, and the necessary conditions for submitting a request for access to data or documents include the provision of legal permission.

Where to obtain:
Name: Shadi Ghadiri- Adress: N0.80, Ardalan 2 Ave, Emam Reza Blv- Postal Code: 3149658857- Tell: 09120427148- 02632533478- Email: shadikio95@gmail.com

How to obtain:
After sending my details and documents including personal, professional and scientific details and also the reason for the need to access project information via email to me, I will contact you at the earliest opportunity and after consulting with the project supervisor and his approval and University information will be sent to you via email. It takes a week to confirm and send the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shadi Ghadiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 80, Ardalan 2 Ave, Emam Reza Blvd, Azadegan Square</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149658857</zip>
        <telephone>0098 26 2533478</telephone>
        <email>shadikio95@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shadi Ghadiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No80, Ardalan 2 Ave, Emam Reza Blvd</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149658857</zip>
        <telephone>+98 26 3253 3478</telephone>
        <email>shadikio95@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 79-60 years
Willingness to attend online sitting sport classes
Have the physical ability to attend sitting sports classes at a distance.
Have the ability to use the tools and facilities needed to participate in online sitting sport classes</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any psychological disorder reported by the individual
History of participation in any virtual sports activities that are similar to the activities intervened in the present study.
Use of psychiatric drugs before the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>41.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed anxiety and depressive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Forming a WhatsApp group - Sending a link to provide online sessions and explanations about it and a link to the online demographic and DASS-21 questionnaires before the intervention - Completing the questionnaires online through the Pors-Line site by individuals - Providing sitting exercises online Through the Skype application by the sports expert trainer, during 12 weeks, three days a week, each session lasts for 30-45 minutes and the exercises are performed by people at the same time. Exercise with soft music including topics such as flexibility, deep breathing with up and down arm pulling, wrist grip, wrist pressure, knee support, quadriceps muscle training and mind focus - Completion of DASS-21 questionnaire after the last session by Persons</i_keyword>
      <i_keyword>Control group: Formation of WhatsApp group - Send the link of online demographic and DASS-21 questionnaires before the intervention - Complete the questionnaires online through the Press Line site - Send only 30-45 minute short sports training videos (if you do not send this period) Video time is cut by WhatsApp, videos are sent in several videos of 10-15 minutes in a group.) Three times a week for 12 weeks in a group - Doing exercises in person if they want to (the exercises are not online and they are not supervised by the constructor and they are not mostly seated exercises so some of the participants may have trouble doing them due to their frailty)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in DASS-21 questionnaire. Timepoint: assessing anxiety at the beginning and end of the research after 3 month of intervention. Method of measurement: anxiety measured by DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>Stress score in DASS-21 questionnaire. Timepoint: assessing Stress at the beginning and end of the research after 3 month of intervention. Method of measurement: Stress measured by DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>Depression score in DASS-21 questionnaire. Timepoint: assessing Depression at the beginning and end of the research after 3 month of intervention. Method of measurement: Depression measured by DASS-21 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>Tehran School of Nursing and Midwifery</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-21</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>13th floor, block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Ghods Town (West), Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
