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IRCT20260328069015N1 IRCT 2026-04-26 Self-funded / No external financial support Effect of Kegel exercises combined with vitamin D and magnesium supplementation on urinary incontinence in postmenopausal wome The effect of eight weeks of Kegel exercises combined with vitamin D3 and magnesium supplementation on lumbar stabilizer muscle thickness and urinary incontinence severity in postmenopausal women 2026-05-09 anticipated 40 Complete https://irct.ir/trial/89357 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a randomized, parallel‑group, single‑blind clinical trial. The intervention consists of pelvic floor muscle exercises combined with a nutritional supplement. Group allocation will be performed using a computer‑generated randomization table, and outcome measurements will be conducted by an assessor blinded to group assignment. Data will be collected through questionnaires, functional tests, and ultrasound assessment of pelvic floor muscles, Randomization description: After obtaining written informed consent, eligible participants were enrolled in the study. To generate the random allocation sequence, a block randomization method with a fixed block size of 4 was used to ensure balance in the number of participants between the intervention and control groups throughout the recruitment process. The random sequence was generated using the statistical software SPSS version 26 (IBM Corp., Armonk, NY, USA). Specifically, all possible allocation permutations within a four-person block were first defined, including six possible arrangements (AABB, ABAB, ABBA, BAAB, BABA, BBAA), where A represented the intervention group and B represented the control group. Subsequently, a uniform random number was generated for each block using the function RV.UNIFORM(0,1), with the random number generator seed set to 2024 to ensure reproducibility. Based on these random numbers, one of the six possible block arrangements was randomly selected for each block. The blocks were then concatenated sequentially to form the final allocation list. Accordingly, every four consecutive participants were assigned to the intervention and control groups according to the predefined block structure, maintaining a 1:1 allocation ratio within each block. To ensure allocation concealment, the final sequence was encoded and placed into sequentially numbered, opaque, sealed envelopes (SNOSE). The envelopes remained sealed until the moment of participant enrollment and were opened sequentially only after each participant had been formally enrolled in the study. All procedures, including random sequence generation, block selection, seed setting, and envelope preparation, were performed by an independent researcher who had no involvement in participant recruitment, intervention implementation, or outcome assessment, thereby minimizing the risk of selection bias, Blinding description: In this trial, participants will not be blinded to the intervention they receive; however, the outcome assessor will be blinded to group allocation. The assessor responsible for measuring muscle thickness, pelvic floor strength and endurance, and urinary incontinence scores will have no access to the allocation list, and group information will be kept confidential. Additionally, the statistical analyst will receive coded data (Group A and Group B) to ensure blinded data analysis. N/A Condition 1: Urinary incontinence. Condition 2: Low back pain. Intervention 1: Intervention group: Participants in the intervention group performed a Kegel exercise program for 8 weeks and simultaneously received vitamin D3 and magnesium supplementation. The exercises were performed three sessions per week, each consisting of three sets of 10 repetitions of pelvic floor muscle contractions, with 8 seconds of contraction followed by 8 seconds of relaxation. In addition, participants received 2000 IU of vitamin D3 and 200 mg of magnesium daily during the intervention period. Intervention 2: Control group: Participants in the control group received placebo during the 8‑week study period. The placebos were prepared as capsules with the same appearance, color, and size as the original supplements but contained no active ingredients and consisted of inert substances such as edible starch or microcrystalline cellulose. The vitamin D placebo was taken once daily, two hours after lunch, and the magnesium placebo was taken once daily at 20:00. These capsules were produced and packaged by Actoverco Pharmaceutical Company. No Kegel exercise program or vitamin D and magnesium supplementation was prescribed for this group, and participants only underwent pre‑test and post‑test assessments similar to the intervention groups. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the need to protect participant confidentiality and prevent disclosure of individual-level data, there is no plan to share Individual Participant Data (IPD). Only aggregated results will be reported in scientific publications.
public Fatemeh Beheshtizadeh
Unit 6, No. 17, North 8th Street, Sazman‑e Ab Street, Marzdaran Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1463634617 +98 913 594 8569 Fatemeh.Beheshtizadeh@iau.ir Islamic Azad University scientific Dr. Hossein Fathollahi
Islamic Azad University, Pardis Branch
Tehran Iran (Islamic Republic of) 1463634617 +98 912 314 8471 hoseyn.fatolahi@iau.ir Islamic Azad University Iran (Islamic Republic of) Postmenopausal women aged 60–65 years At least one year since the last menstrual period Presence of urinary incontinence symptoms (based on ICIQ-SF) No regular physical exercise during the past three months No vitamin D or magnesium supplementation during the previous three months No history of pelvic or lumbar surgery No neurological or musculoskeletal disorders affecting pelvic floor function Ability and willingness to attend training sessions and clinical assessments 60 years 65 years Female Unwillingness to participate in the study or failure to sign the informed consent form. Regular participation in intense training programs or professional sports activities at the time of study entry. Regular consumption of vitamin D or magnesium supplements in recent months that cannot be discontinued or controlled. Presence of musculoskeletal, neurological, or systemic diseases or injuries that limit the ability to perform the exercise program. Use of medications that may affect muscle function, the neuromuscular system, or the urinary system. Known allergy or medical contraindication to vitamin D or magnesium supplementation. Presence of acute or uncontrolled chronic diseases that may interfere with the intervention process or study assessments. Any medical condition that, in the opinion of the physician or the principal investigator, would prevent safe participation in the study.autorenewthumb_upthumb_down N39.4 M54.5 Other specified urinary incontinence Low back pain Rehabilitation Placebo Intervention group: Participants in the intervention group performed a Kegel exercise program for 8 weeks and simultaneously received vitamin D3 and magnesium supplementation. The exercises were performed three sessions per week, each consisting of three sets of 10 repetitions of pelvic floor muscle contractions, with 8 seconds of contraction followed by 8 seconds of relaxation. In addition, participants received 2000 IU of vitamin D3 and 200 mg of magnesium daily during the intervention period. Control group: Participants in the control group received placebo during the 8‑week study period. The placebos were prepared as capsules with the same appearance, color, and size as the original supplements but contained no active ingredients and consisted of inert substances such as edible starch or microcrystalline cellulose. The vitamin D placebo was taken once daily, two hours after lunch, and the magnesium placebo was taken once daily at 20:00. These capsules were produced and packaged by Actoverco Pharmaceutical Company. No Kegel exercise program or vitamin D and magnesium supplementation was prescribed for this group, and participants only underwent pre‑test and post‑test assessments similar to the intervention groups. Urinary incontinence severity. Timepoint: Outcome variables will be measured at two time points: at baseline (before the start of the intervention) and at the end of the eighth week after the intervention. Method of measurement: Urinary incontinence severity was assessed using the International Consultation on Incontinence Questionnaire‑Short Form (ICIQ‑SF). Transversus abdominis muscle thickness by ultrasound. Timepoint: Baseline (pre‑intervention) and Post‑intervention (after 8 weeks). Method of measurement: The thickness of the transversus abdominis muscle was measured using rehabilitative ultrasound imaging with a linear probe (7.5–10 MHz). Participants were positioned in the supine position with knees flexed, and measurements were taken along the mid‑axillary line between the 12th rib and the iliac crest. Three measurements were obtained and the average value was recorded. Multifidus muscle thickness by ultrasound. Timepoint: Baseline (pre‑intervention) and Post‑intervention (after 8 weeks). Method of measurement: The thickness of the lumbar multifidus muscle was measured using rehabilitative ultrasound imaging at the L4–L5 vertebral level. Participants were positioned in the prone position and the ultrasound probe was placed adjacent to the spinous process. Three consecutive measurements were taken and the mean value was recorded. Serum 25‑hydroxyvitamin D level (25(OH)D). Timepoint: Outcome variables will be measured at two time points: at baseline (before the start of the intervention) and at the end of the eighth week after the intervention. Method of measurement: Serum 25‑hydroxyvitamin D levels were measured from fasting blood samples (12‑hour fasting) collected between 8 and 10 a.m. using the ELISA method. Serum magnesium levels. Timepoint: Outcome variables will be measured at two time points: at baseline (before the start of the intervention) and at the end of the eighth week after the intervention. Method of measurement: Serum magnesium concentration was determined from fasting blood samples using a standard enzymatic colorimetric method in a clinical laboratory. Self-funded / No external financial support Approved 2025-12-22 Research Ethics Committee, Islamic Azad University, Central Tehran Branch Block A, 13th Floor, Central Headquarters of the Ministry of Health and Medical Education, Simaye Iran St., between South Flamak St. and Zarafshan St., Shahrak‑e Ghods (West), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)