<?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>IRCT20190908044722N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-29</date_registration>
      <primary_sponsor>Urmia University</primary_sponsor>
      <public_title>The Effect of Handpolo Exercise on Occupational Stress, Motor Fitness, and Perceived Self-Efficacy in Employed Middle-Aged Women with Metabolic Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Handpolo Exercise on Occupational Stress, Motor Fitness, and Perceived Self-Efficacy in Employed Middle-Aged Women with Metabolic Syndrome: A Three-Arm  Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86254</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After completion of the screening process and provision of written informed consent, eligible participants will be randomly assigned in a 1:1:1 ratio to one of three groups: aquatic handpolo exercise, aquatic therapy, or control. To ensure balanced group sizes and minimize allocation bias, randomization will be performed using a block randomization method with variable block sizes (6 and 9). The allocation sequence within each block will be generated in a fully random manner using the Random Allocation Software, Blinding description: To reduce the risk of assessment bias, outcome assessors were blinded to group allocation. All measurements related to balance, motor fitness, and occupational stress were conducted by a trained evaluator who was unaware of participants’ group assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Aquatic Handpolo was implemented over 8 weeks in a total of 16 sessions (2 sessions per week) in an indoor pool with a constant depth of 1.2–1.5 m, water temperature maintained at 34–36°C, and air temperature at approximately 24°C. Each session consisted of a 10-minute warm-up, 45 minutes of Handpolo practice, and a 5-minute cool-down. Exercise intensity was progressively adjusted according to participants’ fitness levels using the Borg Rating of Perceived Exertion scale (RPE = 12–14). Activities were carried out in teams (4 players from each team in the water simultaneously) and included passing, dribbling, moving toward the goal, and scoring. All sessions were supervised by a trained Handpolo coach and a certified lifeguard, with blood pressure and physical condition monitored prior to each session to ensure participants’ safety. Intervention 2: Intervention group 2: Participants in the aquatic exercise group completed an 8-week water-based aerobic training program conducted twice per week, with each 60-minute session consisting of a 10-minute warm-up, 40-minute main exercise, and 10-minute cool-down. The protocol was adapted from the aquatic aerobic program of Yoo et al. (2021) (12) and modified to match the duration and frequency of the present study. The warm-up involved light whole-body movements in water, followed by the main exercise, which included multi-directional dynamic activities such as water jogging, bouncing, jumping jacks, scissors, kicks, rocking horse, leaping, frog jumps, leg curls, twisting heel-toe motions, and ankle mobility drills. Intervention 3: Control Group (Usual Care with Standard Medications):Participants in the control group will continue their usual daily activities without receiving any structured intervention. They may continue their regular medications for metabolic syndrome as prescribed by their physician, but will not receive any new exercise or aquatic program. All assessments and monitoring (occupational stress, motor fitness, and perceived self-efficacy) will be conducted similarly to the intervention groups to ensure comparable conditions and participant safety.</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 The ethical review board overseeing this study recommended against the release of IPD due to concerns about potential misuse or misinterpretation of the data outside of its intended context.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756151818</zip>
        <telephone>43-32752741-044</telephone>
        <email>r.khanmohamadi65@yahoo.com</email>
        <affiliation>Urmia University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756151818</zip>
        <telephone>43-32752741-044</telephone>
        <email>r.khanmohamadi65@yahoo.com</email>
        <affiliation>Urmia University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Full-time or part-time employment for at least the past six months.
Presence of at least three out of five diagnostic criteria for metabolic syndrome according to the NCEP ATP III guidelines
Waist circumference ≥ 88 cm.
Fasting blood glucose ≥ 100 mg/dL or receiving treatment for elevated blood glucose.
Serum triglycerides ≥ 150 mg/dL or under treatment.
HDL cholesterol &lt; 50 mg/dL or under treatment.
Blood pressure ≥ 130/85 mmHg or taking antihypertensive medication.
Enrollment in a center that offers aquatic Handpolo activities.
Ability and willingness to participate in moderate-intensity aquatic physical activity.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy or intention to become pregnant during the study period.
History of cardiovascular, renal, or severe musculoskeletal disorders that contraindicated exercise.
Engagement in a structured exercise program more than twice per week within the past three months
Use of medications significantly affecting lipid metabolism or cortisol levels, beyond standard treatment for metabolic syndrome
Presence of psychiatric or neurological disorders interfering with adherence to the intervention protocol
Inability to attend at least 80% of the scheduled intervention sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Aquatic Handpolo was implemented over 8 weeks in a total of 16 sessions (2 sessions per week) in an indoor pool with a constant depth of 1.2–1.5 m, water temperature maintained at 34–36°C, and air temperature at approximately 24°C. Each session consisted of a 10-minute warm-up, 45 minutes of Handpolo practice, and a 5-minute cool-down. Exercise intensity was progressively adjusted according to participants’ fitness levels using the Borg Rating of Perceived Exertion scale (RPE = 12–14). Activities were carried out in teams (4 players from each team in the water simultaneously) and included passing, dribbling, moving toward the goal, and scoring. All sessions were supervised by a trained Handpolo coach and a certified lifeguard, with blood pressure and physical condition monitored prior to each session to ensure participants’ safety.</i_keyword>
      <i_keyword>Intervention group 2: Participants in the aquatic exercise group completed an 8-week water-based aerobic training program conducted twice per week, with each 60-minute session consisting of a 10-minute warm-up, 40-minute main exercise, and 10-minute cool-down. The protocol was adapted from the aquatic aerobic program of Yoo et al. (2021) (12) and modified to match the duration and frequency of the present study. The warm-up involved light whole-body movements in water, followed by the main exercise, which included multi-directional dynamic activities such as water jogging, bouncing, jumping jacks, scissors, kicks, rocking horse, leaping, frog jumps, leg curls, twisting heel-toe motions, and ankle mobility drills.</i_keyword>
      <i_keyword>Control Group (Usual Care with Standard Medications):Participants in the control group will continue their usual daily activities without receiving any structured intervention. They may continue their regular medications for metabolic syndrome as prescribed by their physician, but will not receive any new exercise or aquatic program. All assessments and monitoring (occupational stress, motor fitness, and perceived self-efficacy) will be conducted similarly to the intervention groups to ensure comparable conditions and participant safety.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic Balance. Timepoint: Before and after intervention. Method of measurement: Dynamic balance will be assessed using the Y-Balance Test, a simplified version of the Star Excursion Balance Test (SEBT). This test evaluates participants’ ability to maintain postural control during functional lower-limb movements. The Y-Balance Test has demonstrated high validity and sensitivity for detecting functional asymmetries and predicting lower-limb injury risk. Intra- and inter-rater reliability has been reported with ICC values between 0.85 and 0.91.</prim_outcome>
      <prim_outcome>Perceived Self-Efficacy. Timepoint: Before and after intervention. Method of measurement: Participants’ perceived self-efficacy will be measured using the General Self-Efficacy Scale (GSES), a 10-item questionnaire rated on a 4-point Likert scale. Higher scores indicate greater self-efficacy. The validated Persian version (Nejati et al., 2005) has acceptable reliability (α = 0.81). The scale will be administered pre- and post-intervention in both groups.</prim_outcome>
      <prim_outcome>Motor Performance. Timepoint: Before and after intervention. Method of measurement: Core muscle endurance will be assessed using the McGill protocol, including tests for trunk flexors, extensors, and right and left lateral flexors. Each test will be performed once with a 3-minute rest interval. The maximum time participants can maintain each position will be recorded in seconds. Equipment will include a bench, 60° inclined surface, stopwatch, and straps.</prim_outcome>
      <prim_outcome>Occupational Stress. Timepoint: Before and after intervention. Method of measurement: Occupational stress will be measured using the HSE Stress Questionnaire, which includes 35 items across 7 domains. The tool has demonstrated acceptable reliability (Cronbach’s α = 0.78).</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>Urmia University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-20</approval_date>
        <contact_name>Ethics committee of Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, Fifth Alley, Miramad Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
