History
# Registration date Revision Id
3 2026-05-18, 1405/02/28 381279
2 2025-11-26, 1404/09/05 364348
1 2025-09-29, 1404/07/07 357069
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  • General information

    2025-09-26, 1404/07/04
    2025-10-02, 1404/07/10
    The hydrotherapy exercises have been replaced with aquatic aerobic exercises.
    The date of admission was before the clinical code was recorded, so it was corrected.
    تمرینات اب درمانی به تمرین ورزش ابی هوازی تغییر یافته است.
    تاریخ بیمار گیری قبل از ثبت کد بالینی بوده است بنابراین اصلاح شد.

Protocol summary

Study aim
to compare the effects of aquatic handpolo exercise and simple aquatic therapy on occupational stress, motor fitness, and perceived self-efficacy in middle-aged women with metabolic syndrome, relative to a control group.
Design
Randomized controlled trial with a control group, three parallel groups, single-blind, conducted on 60 participants. Randomization was performed using the Random Allocation Software.
Settings and conduct
The study will be conducted in city pools offering aquatic handpolo programs. Employed women aged 30–40 years with clinical signs of metabolic syndrome will be recruited through health centers, sports facilities, and workplace wellness programs. All participants will undergo clinical and laboratory screening, including physical examination and blood tests, to confirm eligibility and readiness for aquatic exercise. Physical fitness will be assessed using functional tests and the PAR-Q+ questionnaire. After informed consent, Participants will be randomly assigned to one of three groups (aquatic handpolo, Aqua aerobic , or control). Outcome assessors will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Participants of this study will include employed women aged 30 to 40 years who will have clinical symptoms of metabolic syndrome and will be able to participate in the aquatic handpolo exercise program. The main inclusion criteria will be active employment, being within the specified age range, and confirmation of metabolic syndrome criteria through clinical and laboratory assessments. Exclusion criteria will include the presence of serious cardiovascular or respiratory diseases, medical limitations preventing participation in aquatic exercise, pregnancy,
Intervention groups
Aquatic handpolo exercise group, Aqua aerobic exercise
Main outcome variables
1. Dynamic Balance, Perceived Self-Efficacy, Motor Performance ,Occupational Stress

General information

Reason for update
The date of admission was before the clinical code was recorded, so it was corrected.
Acronym
IRCT registration information
IRCT registration number: IRCT20190908044722N11
Registration date: 2025-09-29, 1404/07/07
Registration timing: prospective

Last update: 2026-06-08, 1405/03/18
Update count: 2
Registration date
2025-09-29, 1404/07/07
Registrant information
Name
Razieh Khanmohamadi
Name of organization / entity
The university of Urmia
Country
Iran (Islamic Republic of)
Phone
+98 86 3221 4311
Email address
r.khanmohamadi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-02, 1404/07/10
Expected recruitment end date
2025-10-26, 1404/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Public title
The Effect of Handpolo Exercise on Occupational Stress, Motor Fitness, and Perceived Self-Efficacy in Employed Middle-Aged Women with Metabolic Syndrome
Purpose
Supportive
Inclusion/Exclusion 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 < 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.
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.
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sport Sciences Research Institute
Street address
No. 3, Fifth Alley, Miramad Street, Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2025-08-20, 1404/05/29
Ethics committee reference number
IR.SSRC.REC.1404.069

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
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

2

Description
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.

3

Description
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.

4

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Rehabilitation

3

Description
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.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
indoor swimming pool of Urmia Municipality Sports Complex.
Full name of responsible person
Razieh Khanmohammadi
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 918 624 2003
Email
r.khanmohamadi65@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University
Full name of responsible person
Abbas Banj Shafiei
Street address
Urmia University, Kilometer 11 of Cypress Road - West Azarbaijan Province -Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
r.khanmohamadi65@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Urmia University
Full name of responsible person
Razieh Khanmohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmohamadi65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University
Full name of responsible person
Razieh Khanmohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmohamadi65@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Urmia University
Full name of responsible person
Razieh Khanmohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
43-32752741-044
Email
r.khanmohamadi65@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The analysis of information obtained from the results of the interventions on Knee Proprioception and Gait Speed can be published
When the data will become available and for how long
From the time the article was published until a year later
To whom data/document is available
All researchers
Under which criteria data/document could be used
Provided Someone wants to do a similar research project
From where data/document is obtainable
r.khanmohamadi65@yahoo.com
What processes are involved for a request to access data/document
Send request by email
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