<?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>IRCT20200628047942N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Exercise at home and taking Q10 supplement in the elderly</public_title>
      <acronym></acronym>
      <scientific_title>Effect of 8 - weeks Combined Training ( endurance and resistance ) with Q10 Supplementation on Antioxidant Balance and Lipid Profile in Elderly People</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method was simple, individual, and sealed using envelopes. So that the names of ten subjects were written in four envelopes and in each one. Then, each of the intervention and control groups was assigned A, B, C, D codes and randomly assigned to one of the training, supplement, exercise, and control groups. Making the envelope, it was determined in which group each of the subjects belonged.</study_design>
      <phase>3</phase>
      <hc_freetext>Antioxidant and lipid profile disorders in elderlies.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Exercise including 5 minutes warm-up and 5 minutes of balance and walking movements and 5 minutes of progressive resistance training and 5 minutes of cooling which were performed for a total of 20 minutes for 5 days a week for 8 weeks. The training method was progressive and according to the level of ability of individuals. With 0.5, 0.75, 1.5 and 1.5 kg weights and 8 repetitive bands for knee extension, flexion and lift, hip extension, flexion, arm back and ankle support movements from sitting to standing. The probability of increasing the number of repetitions could be increased up to 12 times with the Borg pressure scale of 12 to 14. Balance and aerobic movements included walking, lifting on toes, lifting on heels, knee lifting, standing on one leg, shifting body weight in different directions, standing on two legs with or without the help of a chair. Intervention 2: Intervention group: People took two 100 mg capsules of Q10 supplement every morning and evening with food for 8 weeks, using a 100 mg  Q10 Plus  Euro Vital capsule made in Germany. Intervention 3: Intervention group: Exercise including 5 minutes warm-up and 5 minutes of balance and walking movements and 5 minutes of progressive resistance training and 5 minutes of cooling which were performed for a total of 20 minutes for 5 days a week for 8 weeks. The training method was progressive and according to the level of ability of individuals. With 0.5, 0.75, 1.5 and 1.5 kg weights and 8 repetitive bands for knee extension, flexion and lift, hip extension, flexion, arm back and ankle support movements from sitting to standing. The probability of increasing the number of repetitions could be increased up to 12 times with the Borg pressure scale of 12 to 14. Balance and aerobic movements included walking, lifting on toes, lifting on heels, knee lifting, standing on one leg, shifting body weight in different directions, standing on two legs with or without the help of a chair.Intervention group: People took two 100 mg capsules of Q10 supplement every morning and evening with food for 8 weeks, using a 100 mg  Q10 Plus  Euro Vital capsule made in Germany. Intervention 4: Control group: Taking placebo every day for 8 weeks, two capsules containing wheat flour were used, which were similar in packaging, color, and taste to the Q10 supplement.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Salekani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, West Vahdati, Nahid St, Marzdaran Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461714751</zip>
        <telephone>+98 21 4422 2628</telephone>
        <email>sahar.slk10@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar Salekani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, West vahdati, Nahid St, Marzdaran Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461714751</zip>
        <telephone>+98 21 4422 2628</telephone>
        <email>sahar.slk10@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An elderly person with age 60 to 70
Speaking in Farsi
Being completely cautious during this study
Having communication ability
Having ability to answer the questionnaires
Living in Tehran
Being inactive and do not have any physical activity or exercise during the week</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Active people based on the questionnaire
Have any known mental illness (psychosis)
Being less than 60 or more than 75 years old</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Exercise including 5 minutes warm-up and 5 minutes of balance and walking movements and 5 minutes of progressive resistance training and 5 minutes of cooling which were performed for a total of 20 minutes for 5 days a week for 8 weeks. The training method was progressive and according to the level of ability of individuals. With 0.5, 0.75, 1.5 and 1.5 kg weights and 8 repetitive bands for knee extension, flexion and lift, hip extension, flexion, arm back and ankle support movements from sitting to standing. The probability of increasing the number of repetitions could be increased up to 12 times with the Borg pressure scale of 12 to 14. Balance and aerobic movements included walking, lifting on toes, lifting on heels, knee lifting, standing on one leg, shifting body weight in different directions, standing on two legs with or without the help of a chair.</i_keyword>
      <i_keyword>Intervention group: People took two 100 mg capsules of Q10 supplement every morning and evening with food for 8 weeks, using a 100 mg  Q10 Plus  Euro Vital capsule made in Germany.</i_keyword>
      <i_keyword>Intervention group: Exercise including 5 minutes warm-up and 5 minutes of balance and walking movements and 5 minutes of progressive resistance training and 5 minutes of cooling which were performed for a total of 20 minutes for 5 days a week for 8 weeks. The training method was progressive and according to the level of ability of individuals. With 0.5, 0.75, 1.5 and 1.5 kg weights and 8 repetitive bands for knee extension, flexion and lift, hip extension, flexion, arm back and ankle support movements from sitting to standing. The probability of increasing the number of repetitions could be increased up to 12 times with the Borg pressure scale of 12 to 14. Balance and aerobic movements included walking, lifting on toes, lifting on heels, knee lifting, standing on one leg, shifting body weight in different directions, standing on two legs with or without the help of a chair.Intervention group: People took two 100 mg capsules of Q10 supplement every morning and evening with food for 8 weeks, using a 100 mg  Q10 Plus  Euro Vital capsule made in Germany.</i_keyword>
      <i_keyword>Control group: Taking placebo every day for 8 weeks, two capsules containing wheat flour were used, which were similar in packaging, color, and taste to the Q10 supplement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Antioxidant Balance. Timepoint: Before the intervention and 48 hours after the end of 8-week exercise and supplementation interventions. Method of measurement: Serum Concentration Measurement Using ELISA Laoratory Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid Profile. Timepoint: Before the intervention and 48 hours after the end of the 8-week exercise and supplementation interventions. Method of measurement: Serum Concentration Measurement Using ELISA Laboratory Kit.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-22</approval_date>
        <contact_name>Sport Sciences Research institute of Iran</contact_name>
        <contact_address>No.3, 5th Ave, Miremad St, Motaharri St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
