<?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>IRCT20230810059112N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of combined exercise on plasma levels of alpha-glucose, sirtuin 1, oxidative enzymes, lipid profile and glucose homeostasis in obese men aged 60 to 70 years.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined exercise on plasma levels of alpha-klotho, sirtuin 1, oxidative enzymes, lipid profile and glucose homeostasis in obese men aged 60 to 70 years.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72050</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Random assignment to intervention and control groups
The simple random method of the lottery method, each name removed was placed in one of the two study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The study subjects are obese.</hc_freetext>
      <i_freetext>Intervention 1: IntervIn this study, the intervention is sports training, which will be combined training (resistance, endurance) for 16 weeks and 3 sessions per week for 60 minutes. Before the start of the training period, in order to know about the health status and level of preparation of the people, the PARQ physical activity readiness questionnaire will be used. Before starting the main exercises, the subjects are taught exercises for a week. The combined training group has a 16-week training program that consists of three sessions each week and each session lasts 60 minutes. Aerobic and resistance exercises will be held in the morning (6:30 to 7:30). First stage, general warm-up for 10 minutes (walking, soft running, stretching and mobility), performing aerobic exercises for 45 to 60 minutes with an intensity equal to 50 to 70 percent of the reserve heart rate and a training session that gradually It starts from 30 minutes and increases to 60 minutes at the end of the course (Hijazi, 2017). Weight training can be harmful for inexperienced seniors unless it is done under the supervision of a trainer. Therefore, doing resistance exercises with body weight can be more safe and attractive for the elderly, that's why resistance exercises for 10 to 15 minutes with weight bearing to strengthen the muscles of the lower and middle limbs with movements such as squats, lunges, long and Sit-ups, planks and lateral planks (both sides of the body), triceps dip will take place in Lahijan Park (Lahijan Pool). which starts with 2 sets of 10 repetitions in the first weeks and increases to 3 sets of 15 repetitions in the 16th week. At the end of each training session, the body returns to its initial state and cools down for 10 minutes (slow running, walking and stretching exercises). will be done. These exercises will last up to 16 weeks. Anthropometric tests will be done 48 hours before and laboratory tests before the first training session, and after 16 weeks of training, tests and blood tests will be repeated for both groups. It should also be mentioned that at the beginning and after 16 weeks of training, laboratory tests including SαKl, SIRT1, CAT, ROS, SOD, IGF-1, HDL, LDL, cholesterol and triglycerides, FBS, insulin and HOMA-IR blood serum, capacity It is a plasma antioxidant. It should be noted that blood samples are collected 24 hours before training and 24 hours after training for both groups. Sampling will be done between 8 and 10 am in the laboratory, from the vein of the left hand of each subject, while sitting and resting (Hijazi, 2017). Blood samples will be poured into test tubes containing anticoagulant. Then it is centrifuged at 3000 rpm for 10 minutes and the separated plasma is used for analysis. Also, field tests including stand-up and walking time test, Rockport test, consecutive jumps for anaerobic power, hand and paw strength test for upper limb strength, lower limb muscle strength from "sitting on a chair for 30 seconds" test will be used.ention group:. Intervention 2: Control group:  This group performed field and laboratory tests at the beginning and after 16 weeks, and no intervention was performed.</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:
In the study of the effect of combined training on the plasma levels of alpha klotho,  1, oxidative enzymes, lipid profile and glucose homeostasis in obese men 60 to 70 years after being unidentifiable, part of the data and the outcome of the type of training can be shared.

When:
Beginning of access in the first half of 2024 until 6 months after the publication of the article.

To whom:
Researchers working in academic and scientific institutions are available.

Conditions:
The use of data should be within the framework of the laws and should not be misused.

Where to obtain:
To the researcher - Islamic Azad University, Rasht branch

How to obtain:
Send a message to the researcher's email. Responds as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Safari Sharafshadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lacan Gate, Rasht Azad University, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 4080</telephone>
        <email>ma6692.safari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lacan Gate, Rasht Azad University, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 4080</telephone>
        <email>shabani_msn@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The subjects were between 60 and 70 years old
People who have the ability to implement the training protocol and tests
Stable body weight (±5 kg) for at least six months
Ability to perform the exercise intervention (exercise capacity) and participants consuming an omnivorous diet</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of orthopedic diseases in the last 5 years and vision problems
Having daily sports activities for at least two years
Having suspicious cases such as cardiovascular disease, angina pectoris, myocardial infarction, stroke, peripheral artery occlusion disease
Having kidney failure and liver disease, coagulation disorders, chronic gastrointestinal disorders (e.g. Crohn's disease), pancreatic insufficiency, immunological disease (e.g. autoimmune disease) and not taking immunosuppressive drugs or laxatives, heart failure, cardiac arrhythmia, type 1 and 2 diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>IntervIn this study, the intervention is sports training, which will be combined training (resistance, endurance) for 16 weeks and 3 sessions per week for 60 minutes. Before the start of the training period, in order to know about the health status and level of preparation of the people, the PARQ physical activity readiness questionnaire will be used. Before starting the main exercises, the subjects are taught exercises for a week. The combined training group has a 16-week training program that consists of three sessions each week and each session lasts 60 minutes. Aerobic and resistance exercises will be held in the morning (6:30 to 7:30). First stage, general warm-up for 10 minutes (walking, soft running, stretching and mobility), performing aerobic exercises for 45 to 60 minutes with an intensity equal to 50 to 70 percent of the reserve heart rate and a training session that gradually It starts from 30 minutes and increases to 60 minutes at the end of the course (Hijazi, 2017). Weight training can be harmful for inexperienced seniors unless it is done under the supervision of a trainer. Therefore, doing resistance exercises with body weight can be more safe and attractive for the elderly, that's why resistance exercises for 10 to 15 minutes with weight bearing to strengthen the muscles of the lower and middle limbs with movements such as squats, lunges, long and Sit-ups, planks and lateral planks (both sides of the body), triceps dip will take place in Lahijan Park (Lahijan Pool). which starts with 2 sets of 10 repetitions in the first weeks and increases to 3 sets of 15 repetitions in the 16th week. At the end of each training session, the body returns to its initial state and cools down for 10 minutes (slow running, walking and stretching exercises). will be done. These exercises will last up to 16 weeks. Anthropometric tests will be done 48 hours before and laboratory tests before the first training session, and after 16 weeks of training, tests and blood tests will be repeated for both groups. It should also be mentioned that at the beginning and after 16 weeks of training, laboratory tests including SαKl, SIRT1, CAT, ROS, SOD, IGF-1, HDL, LDL, cholesterol and triglycerides, FBS, insulin and HOMA-IR blood serum, capacity It is a plasma antioxidant. It should be noted that blood samples are collected 24 hours before training and 24 hours after training for both groups. Sampling will be done between 8 and 10 am in the laboratory, from the vein of the left hand of each subject, while sitting and resting (Hijazi, 2017). Blood samples will be poured into test tubes containing anticoagulant. Then it is centrifuged at 3000 rpm for 10 minutes and the separated plasma is used for analysis. Also, field tests including stand-up and walking time test, Rockport test, consecutive jumps for anaerobic power, hand and paw strength test for upper limb strength, lower limb muscle strength from "sitting on a chair for 30 seconds" test will be used.ention group:</i_keyword>
      <i_keyword>Control group:  This group performed field and laboratory tests at the beginning and after 16 weeks, and no intervention was performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Levels of klotho. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Sirtuin1. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Catalase enzyme. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Superoxide dismutase enzyme. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>FOXO1. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Insulin-like growth factor-1 (IGF-1). Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: By photometric enzymic calorimetric.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: Enzymatic calorimetric method.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: Enzymatic calorimetric method.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: Through the equation of Friedwald et al(LDL = TC - HDL - TG/0.5.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: Enzymatic photometric method.</prim_outcome>
      <prim_outcome>Ability and capacity to perform basic movements and mobility. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: TUG standing and walking time test.</prim_outcome>
      <prim_outcome>Aerobic strength. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: Using Racport.</prim_outcome>
      <prim_outcome>Hand and paw strength test(hand grip). Timepoint: Before and after the end of 16 weeks of training. Method of measurement: Hand and paw strength test(hand grip)with a dynamometer.</prim_outcome>
      <prim_outcome>Lower body muscle strength. Timepoint: Before and after the end of 16 weeks of training. Method of measurement: 30 second sitting on a chair test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure and heart rate. Timepoint: Before and after 16 weeks of training. Method of measurement: Variables were measured at rest and after exercise with a sphygmomanometer, systolic and diastolic blood pressure and heart rate.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Before and after 16 weeks of training. Method of measurement: Using weight, body mass index, waist to hip ratio and fat percentage.</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>2022-07-20</approval_date>
        <contact_name>Islamic Azad University-Rasht Branch (Research Ethics Committee)</contact_name>
        <contact_address>Lakani Street - Azad University, Rasht Branch Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
