<?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>IRCT20260621069896N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-23</date_registration>
      <primary_sponsor>yazd University</primary_sponsor>
      <public_title>The effect of resistance training combined with vitamin D supplementation on IGF-1 levels, neuromuscular function, and muscle strength in elderly women with sarcopenia</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Resistance Training Combined with Vitamin D Supplementation on IGF-1 Levels and Neuromuscular Junction Function (Anti-Acetylcholine Receptor Antibody) in Elderly Women with Sarcopenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Health service research, Other design features: This study is a quasi-experimental study with a pretest-posttest design and a control group and a 2x2 factorial design. The two intervention factors included “resistance training” (two levels: yes/no) and “vitamin D supplementation” (two levels: yes/no). Eligible participants were randomly assigned to four parallel groups (resistance training + vitamin D, resistance training alone, vitamin D alone, and control). The intervention duration was 8 weeks and the main objective was to evaluate the main effect of each intervention as well as the interaction effect (synergistic effect) between resistance training and vitamin D on IGF-1 levels, neuromuscular junction function, and muscle performance indices, Randomization description: After assessing the inclusion and exclusion criteria, eligible participants were randomly assigned to four groups (resistance training + vitamin D, resistance training, vitamin D, and control). The randomization method was block randomization with a block size of 4, which was performed using Excel software to maintain a balance in the number of individuals in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sarcopenia.</hc_freetext>
      <i_freetext>Intervention group: Control group:Participants in this group did not receive any training intervention or supplementation and continued their daily activities.Intervention group 1 (resistance training with vitamin D supplementation):The intervention consisted of two concurrent parts:Resistance training: 8 weeks, 3 sessions per week (non-consecutive days), at an intensity of 60-75% of one repetition maximum (1RM), including 8 main movements (4 upper body movements and 4 lower body movements) in 3 sets of 10-12 repetitions with 1-2 minutes of rest between sets. Sessions were performed under the direct supervision of an exercise physiologist.Vitamin D supplementation: Oral intake of 50,000 IU of vitamin D3 (cholecalciferol) weekly for 8 weeks.Intervention group 2 (resistance training alone):Exactly the same resistance training protocol as group 1 (8 weeks, 3 sessions per week, 60-75% of 1RM, 8 movements, 3 sets of 10-12 repetitions) without receiving any supplementation.Third intervention group (vitamin D supplementation alone):Oral intake of 50,000 IU of vitamin D3 (cholecalciferol) weekly for 8 weeks, without performing a resistance training program..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the sensitive nature of personal health data of elderly participants and ethical considerations regarding privacy and confidentiality, there is no plan to share individual participant data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hossein barzegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>yazd university</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۸۱۸۴۱۱</zip>
        <telephone>+98 35 3123 4038</telephone>
        <email>hosseinbarzegarimarvast@gmail.com</email>
        <affiliation>yazd university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hossein barzegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>yazd university</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۸۱۸۴۱۱</zip>
        <telephone>+98 35 3123 4038</telephone>
        <email>h.barzegari@staff.yazd.ac.ir</email>
        <affiliation>yazd university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly women with sarcopenia according to EWGSOP2 criteria
Age 60-70 years
Resident of Aligudarz city
Ability to participate in resistance training program (without severe movement restriction)
No vitamin D supplementation in the last 3 months
Informed consent to participate in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Advanced or unstable cardiovascular disease
Uncontrolled blood pressure (above 160/100 mmHg)
Untreated thyroid disorders
Renal failure (Cr &gt; 1.5 mg/dL or GFR &lt; 60)
Vitamin D supplementation in the last 3 months
Any medical contraindication to resistance training
Severe mobility limitations or inability to perform functional tests
Active inflammatory or autoimmune diseases (such as rheumatoid arthritis)
Use of medications that affect bone and muscle metabolism (such as corticosteroids)
Unwillingness or inability to provide informed consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>کاهش توده و قدرت عضلانی مرتبط با سن</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Control group:Participants in this group did not receive any training intervention or supplementation and continued their daily activities.Intervention group 1 (resistance training with vitamin D supplementation):The intervention consisted of two concurrent parts:Resistance training: 8 weeks, 3 sessions per week (non-consecutive days), at an intensity of 60-75% of one repetition maximum (1RM), including 8 main movements (4 upper body movements and 4 lower body movements) in 3 sets of 10-12 repetitions with 1-2 minutes of rest between sets. Sessions were performed under the direct supervision of an exercise physiologist.Vitamin D supplementation: Oral intake of 50,000 IU of vitamin D3 (cholecalciferol) weekly for 8 weeks.Intervention group 2 (resistance training alone):Exactly the same resistance training protocol as group 1 (8 weeks, 3 sessions per week, 60-75% of 1RM, 8 movements, 3 sets of 10-12 repetitions) without receiving any supplementation.Third intervention group (vitamin D supplementation alone):Oral intake of 50,000 IU of vitamin D3 (cholecalciferol) weekly for 8 weeks, without performing a resistance training program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum IGF-1 levels. Timepoint: They were measured at two time points: pre-test (48 to 72 hours before the start of the intervention) and post-test (48 to 72 hours after the completion of the 8-week intervention). Method of measurement: They were measured using enzyme-linked immunosorbent assay (ELISA) and special kits. Insulin-like growth factor type 1 levels were measured with a German Mediagnosis kit.</prim_outcome>
      <prim_outcome>Anti-AChR Ab. Timepoint: They were measured at two time points: pre-test (48 to 72 hours before the start of the intervention) and post-test (48 to 72 hours after the completion of the 8-week intervention). Method of measurement: They were measured using enzyme-linked immunosorbent assay (ELISA) and special kits. Acetylcholine receptor antibody levels were measured with a Hanyin Biotech China kit.</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>yazd University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-04-29</approval_date>
        <contact_name>yazd university</contact_name>
        <contact_address>yazd university yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
