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IRCT20260421069124N1 IRCT 2026-06-08 Kharazmi University The Effect of Combined Kegel and DNS Exercises on Pain and Functional in Postpartum Women" The effect of adding kegel exercises to DNS exercises on pain, electrical muscle activity, lumbopelvic rhythm, pelvic floor function, disability and quality of life with lumbopelvic pain in postpartum women 2026-06-10 anticipated 42 Recruiting https://irct.ir/trial/90527 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants will be randomly allocated to the three study groups (Control group, Exercise Group 1, and Exercise Group 2) in a 1:1:1 ratio. Block randomization with varying block sizes of 3 and 6 will be performed using Random Allocation Software (version 2.0). Allocation concealment will be ensured by using sequentially numbered, opaque, and sealed envelopes. These envelopes will be prepared in advance by an independent individual not involved in the study team. The envelopes will be opened sequentially according to the order of participant enrollment, Blinding description: Due to the nature of the exercise interventions, it is not possible to blind the participants or the exercise instructors. This study is therefore designed as a single-blind randomized controlled trial. Outcome assessors (who perform the pre- and post-intervention evaluations including pain intensity, ASLR test, sacroiliac joint provocation tests, and questionnaires) will be blinded to group allocation. To maintain blinding, assessors will not be involved in the randomization process, exercise training sessions, or data analysis. Participants will be instructed not to disclose their group assignment or type of exercises to the assessors during assessments. N/A lumbopelvic pain in postpartum women. Intervention 1: First Intervention group: Dns exercises. Intervention 2: Second intervention group: DNS exercises combined with Kegel exercises. Intervention 3: Control group:. Yes - There is a plan to make this available What will be shared: Only the primary findings will be shared When: “Access will commence one year after the publication of the results To whom: “Researchers employed at academic and scientific institutions Conditions: “Data and documentation will be provided exclusively for research and scientific purposes to qualified researchers. Commercial use or use outside the approved research framework is prohibited. Access is contingent upon a written request and ethics committee approval.” Where to obtain: “To access data/documentation, applicants should submit their request to the Principal Investigator or Research Lead via email or formal correspondence. Requests will be processed and provided to applicants upon review and approval by the Research Ethics Committee, contingent upon meeting all requirements.” How to obtain: Data/Documentation Access Procedure: 1. Submit a formal written request. 2. Verification of applicant’s identity and alignment with research ethics guidelines. 3. Signing of a Data Use Agreement (DUA) followed by data/documentation provision. Approximate timeframe: 2-4 weeks.** Comments:
public Akram keikha hosseinpoor
Faculty of Physical Education and Sport Sciences, Kharazmi University, Kharazmi Blvd
karaj Iran (Islamic Republic of) 3197937551 +98 937 079 3697 akramkeykha@gmail.com Kharazmi Univercity scientific Akram keikha hosseinpoor
Faculty of Physical Education and Sport Sciences, Kharazmi University, Kharazmi Blvd
karaj Iran (Islamic Republic of) 3197937551 +98 937 079 3697 akramkeykha@gmail.com Kharazmi University Iran (Islamic Republic of) Women aged 20–40 years with a history of singleton vaginal delivery in the past 3 to 12 months. Diagnosis of non-specific low back pain, pelvic girdle pain, or a combination of both, with onset during pregnancy or at least 3 weeks postpartum, confirmed by a specialist physician. Positive Active Straight Leg Raise (ASLR) test and positive results in at least three out of the following six sacroiliac joint provocation tests: distraction test, compression test, posterior shear test (thigh thrust), Gaenslen’s test (right), Gaenslen’s test (left), and sacral thrust test. Pain intensity between 3 and 7 (on a 0–10 Visual Analog Scale – VAS) at the time of assessment or during the past two weeks. ody Mass Index (BMI) less than 30 kg/m² 20 years 40 years Female Spinal abnormalities or pathological conditions of the spine (such as spinal stenosis, scoliosis, spondylolisthesis, fracture, tumors of the spine or pelvis, etc.). History of neurological, cardiovascular, respiratory, renal diseases, or rheumatoid arthritis. History of surgical intervention in the lumbopelvic region. Postpartum urinary disorders (including urinary incontinence and/or urinary retention). Urogenital prolapse greater than grade 3. History of cesarean section or more than two vaginal deliveries. Failure to complete at least 90% of the study sessions. Use of any concurrent medications or physiotherapy interventions during the study period. Rehabilitation Rehabilitation N/A First Intervention group: Dns exercises Second intervention group: DNS exercises combined with Kegel exercises. Control group: Pain. Timepoint: Baseline (T0), post-intervention (T1, Afer 8 weeks). Method of measurement: The Visual Analog Scale (VAS) is the most common scale for reporting pain. The patient will select a number corresponding to a pain ruler from 0 to 10 that best represents the intensity of their pain. Zero indicates no pain, and 10 indicates the worst imaginable pain. This scale is often categorized as follows: no pain (0), mild pain (1-3), moderate pain (4-6), severe pain (7-10). The reported reliability of the Visual Analog Scale is 0.91. Disability. Timepoint: Baseline (T0), post-intervention (T1, Afer 8 weeks). Method of measurement: Disability will be assessed using the Oswestry Disability Index (ODI). The ODI is a 10-item self-administered questionnaire designed to assess pain-related disability in individuals with low back pain. Each item is scored on a scale of 0 to 5, with 0 indicating no disability and 5 indicating the highest level of disability. The total score ranges from 0% to 100%, with higher scores indicating greater disability. The Persian version of the ODI, which has demonstrated reliability and validity characteristics in individuals with low back pain, will be used in this study. Lumbopelvic rhythm. Timepoint: At baseline and at the end of the intervention (after 8 weeks). Method of measurement: Shimmer3 IMU sensors (100 Hz frequency) will be used to record the movement angles of the lumbar spine and pelvis. The IMUs will be placed on the S1 vertebra (lower back) and T12 vertebra (mid-back), and on the femur to measure the flexion/extension angle and the lumbopelvic rhythm (the ratio of pelvic to lumbar movement). Muscle activity. Timepoint: At baseline and at the end of the intervention (after 8 weeks). Method of measurement: Surface electromyography (sEMG) data from the transversus abdominis (TrA), multifidus (MF), and rectus abdominis (RA) muscles on both dominant and non-dominant sides will be recorded using a six-channel Noraxon (USA) wireless FREEEMG system (sampling frequency 2000 Hz). Surface electrodes (Ag/AgCl, 12 mm diameter) will be placed along the muscle fibers of each muscle by a trained researcher, following SENIAM guidelines. Before electrode placement, the skin will be cleaned with isopropyl alcohol and abraded to reduce inter-electrode resistance. The electrodes will be placed on the TrA (4 cm below and medial to the anterior superior iliac spine), MF (at the L4-L5 vertebral level, 2 cm lateral to the midline), and RA (2 cm lateral to the umbilicus, 1 cm above and 1 cm below, parallel to the RA muscle fibers). The signals will be processed with a band-pass filter (20-450 Hz) and normalized based on maximum voluntary contraction (MVC). Electromyography data will be recorded during a box-lifting movement (lifting a box from the floor and standing up). RMS will be used after data recording and filtering to quantify muscle electrical activity. Pelvic floor function. Timepoint: At baseline and at the end of the intervention (after 8 weeks). Method of measurement: The Pelvic Floor Distress Inventory (PFDI-20) is a standardized and valid instrument designed to assess the severity of symptoms related to pelvic floor disorders in women. This questionnaire is specifically used to evaluate the impact of pelvic floor problems on quality of life and daily functioning, and it is applied in areas such as urinary incontinence, fecal incontinence, and pelvic organ prolapse. The internal consistency reliability of the total questionnaire was 0.89, indicating high internal reliability, and the test-retest reliability, measured by the intraclass correlation coefficient (ICC), was 0.92 for the total questionnaire, indicating excellent temporal reliability. Quality of Life. Timepoint: At baseline and at the end of the intervention (after 8 weeks). Method of measurement: Quality of life will be assessed using the 36-item Short Form Health Survey (SF-36). This questionnaire consists of 36 questions and is comprised of 8 subscales, with each subscale containing 2 to 10 items. The eight subscales of this questionnaire are: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Additionally, by combining subscales, two overall scales named physical health (which measures the physical aspect of health) and mental health (which evaluates the psychosocial aspect of health) are derived. A subject’s score for each question in this questionnaire ranges from 0 to 100, with a higher score indicating better quality of life. Kharazmi University Approved 2026-04-19 The Ethics Committee of Kharazmi University. Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St tehran Alborz Iran (Islamic Republic of)