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IRCT20211201053244N10 IRCT 2026-07-12 University of Sistan and Baluchistan Comparing the Effects of Different Exercise Programs for Chronic Back Pain in Middle-Aged Women Comparison of Pilates, Pelvic Floor Training, and Combined Programs on Pain and Function in Middle-Aged Women with Chronic Low Back Pain 2026-08-06 anticipated 60 Pending https://irct.ir/trial/91430 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No additional unique design features. Standard parallel-group RCT with supervised interventions and blinded outcome assessment. Control group receives no structured exercise, Randomization description: Participants will be assigned to one of four groups (Pilates, Pelvic Floor Muscle Training (PFMT), Combined Program, or Control) using a simple randomization method with a 1:1:1:1 allocation ratio. The randomization sequence will be generated using a random number table created by SPSS software (version 26) prior to the start of the study. The unit of randomization is the individual participant. To ensure allocation concealment, the generated sequence will be placed into opaque, sealed, and sequentially numbered envelopes by an independent researcher who is not involved in the recruitment, assessment, or intervention process. After the baseline assessments (pre-test) are completed, the next envelope in the sequence will be opened by the same independent researcher, who will then inform the participant of their group allocation. Neither the outcome assessor nor the participants will have access to the randomization list or the contents of the unopened envelopes, Blinding description: Single Blind (Outcome assessor blinded to group allocation; participants and care providers cannot be blinded due to the nature of exercise interventions). To maintain blinding, the outcome assessor will not be present during the intervention sessions, will have no access to the randomization list, and participants will be instructed not to discuss their group assignment with the assessor during the post-test assessments. N/A Chronic nonspecific low back pain. Intervention 1: Intervention group 1: Pilates Exercise Program: An 8-week mat Pilates exercise program consisting of 3 sessions per week, each lasting 50-60 minutes. The program includes a 10-minute warm-up, 30-40 minutes of mat Pilates exercises focusing on deep core muscle activation (transversus abdominis, multifidus, diaphragm, and oblique muscles), spinal stabilization, and controlled breathing, followed by a 5-10 minute cool-down and stretching. Exercise intensity progresses gradually from simple supine and quadruped positions to more challenging sitting and standing positions. All sessions are supervised by a trained Pilates instructor. Intervention 2: Intervention group 2: Pelvic Floor Muscle Training Program: An 8-week pelvic floor muscle training program consisting of 3 sessions per week, each lasting 30-45 minutes. The program includes voluntary, controlled, and repetitive contractions of the pelvic floor muscles, initially performed in simple positions (supine and sitting) and progressing to more functional positions (standing). Training includes sustained contractions (5-10 seconds), rapid contractions, and breathing coordination exercises. Intensity progresses gradually. Emphasis is placed on preventing compensatory movements by superficial abdominal and gluteal muscles. All sessions are supervised by a trained therapist. Intervention 3: Intervention group 3: Combined Program (Pilates + Pelvic Floor Muscle Training): An 8-week combined program integrating Pilates exercises and pelvic floor muscle training, consisting of 3 sessions per week, each lasting 60 minutes. Pelvic floor muscle training is incorporated as part of neuromuscular preparation at the beginning of each session and integrated throughout Pilates movements. The program emphasizes coordination between pelvic floor muscles and deep core muscles, regulation of intra-abdominal pressure, and improvement of lumbopelvic motor control. Exercise intensity and complexity progress gradually from stable to more challenging positions. All sessions are supervised by a trained instructor. Intervention 4: Control Group: No Structured Exercise: Participants in the control group do not receive any structured exercise intervention during the 8-week study period. They are advised to maintain their usual daily activities and avoid starting any new exercise programs or similar therapeutic interventions during the study period. At the end of the study, an appropriate exercise program will be offered to them educationally upon request. No - There is not a plan to make this available Justification or reason for not sharing IPD is The deidentified individual participant data (IPD) collected in this study will not be publicly available due to ethical and privacy considerations. However, the study protocol, statistical analysis plan, informed consent form, and clinical study report will be made available to other researchers upon reasonable request to the corresponding author. Data sharing requests will be reviewed by the research team and the ethics committee of the University of Sistan and Baluchestan to ensure compliance with ethical standards and participant privacy. Access to IPD may be granted for meta-analyses or systematic reviews with a valid scientific rationale, subject to a data sharing agreement. All shared data will be fully anonymized to protect participant identities. The analytic code and data dictionary may be shared upon request after the completion and publication of the study results.
public Mohammadreza Rezaeipor
University of Sistan and Baluchestan housing
ZAhedan Iran (Islamic Republic of) 9816745639 +98 54 3113 6727 rezaeipour@ped.usb.ac.ir University of Sistan and Baluchestan scientific Mohammadreza Rezaeipour.
University Professors' Neighborhood of Sistan and Baluchestan University.
Zahedan Iran (Islamic Republic of) 9816745639 +98 54 3113 2674 rezaeipour@ped.usb.ac.ir University of Sistan and Baluchistan Iran (Islamic Republic of) Female gender and age between 40 and 65 years. Diagnosis of chronic nonspecific low back pain (CNSLBP) with a history of pain lasting more than 12 weeks. Pain intensity of at least 3 out of 10 on the Visual Analog Scale (VAS) at the time of enrollment. Ability to perform moderate physical activity and no medical contraindication for exercise. Willingness to participate and provide written informed consent. 40 years 65 years Female History of spinal, pelvic, or lower limb surgery. History of specific spinal pathologies (e.g., tumors, infections, fractures, inflammatory disorders). Presence of severe neurological signs or clinical radiculopathy (e.g., significant muscle weakness, sensory loss). Pregnancy or childbirth in the last 6 months. Concurrent participation in another structured exercise or physical therapy program. M54.5 Low back pain Rehabilitation Rehabilitation Rehabilitation N/A Intervention group 1: Pilates Exercise Program: An 8-week mat Pilates exercise program consisting of 3 sessions per week, each lasting 50-60 minutes. The program includes a 10-minute warm-up, 30-40 minutes of mat Pilates exercises focusing on deep core muscle activation (transversus abdominis, multifidus, diaphragm, and oblique muscles), spinal stabilization, and controlled breathing, followed by a 5-10 minute cool-down and stretching. Exercise intensity progresses gradually from simple supine and quadruped positions to more challenging sitting and standing positions. All sessions are supervised by a trained Pilates instructor. Intervention group 2: Pelvic Floor Muscle Training Program: An 8-week pelvic floor muscle training program consisting of 3 sessions per week, each lasting 30-45 minutes. The program includes voluntary, controlled, and repetitive contractions of the pelvic floor muscles, initially performed in simple positions (supine and sitting) and progressing to more functional positions (standing). Training includes sustained contractions (5-10 seconds), rapid contractions, and breathing coordination exercises. Intensity progresses gradually. Emphasis is placed on preventing compensatory movements by superficial abdominal and gluteal muscles. All sessions are supervised by a trained therapist. Intervention group 3: Combined Program (Pilates + Pelvic Floor Muscle Training): An 8-week combined program integrating Pilates exercises and pelvic floor muscle training, consisting of 3 sessions per week, each lasting 60 minutes. Pelvic floor muscle training is incorporated as part of neuromuscular preparation at the beginning of each session and integrated throughout Pilates movements. The program emphasizes coordination between pelvic floor muscles and deep core muscles, regulation of intra-abdominal pressure, and improvement of lumbopelvic motor control. Exercise intensity and complexity progress gradually from stable to more challenging positions. All sessions are supervised by a trained instructor. Control Group: No Structured Exercise: Participants in the control group do not receive any structured exercise intervention during the 8-week study period. They are advised to maintain their usual daily activities and avoid starting any new exercise programs or similar therapeutic interventions during the study period. At the end of the study, an appropriate exercise program will be offered to them educationally upon request. Pain intensity. Timepoint: Baseline (before intervention) and immediately after 8 weeks of intervention (post-test). Method of measurement: Visual Analogue Scale (VAS) - a 10-centimeter line where 0 indicates no pain and 10 indicates the worst imaginable pain; participants mark their current pain level on the line. Functional disability. Timepoint: Baseline (before intervention) and immediately after 8 weeks of intervention (post-test). Method of measurement: Oswestry Disability Index (ODI) - a validated 10-item questionnaire assessing the impact of low back pain on daily activities, including personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment; each item scored 0 to 5; total score converted to percentage (0-100%). Trunk muscle endurance. Timepoint: Baseline (before intervention) and immediately after 8 weeks of intervention (post-test). Method of measurement: McGill Core Endurance Tests - three timed tests including: (1) Trunk flexor endurance test (holding a 60-degree sit-up position); (2) Trunk extensor endurance test (holding a prone position with upper body unsupported); (3) Side-bridge endurance test (holding a side-lying plank position). Holding time in seconds is recorded for each test. Motor control. Timepoint: Baseline (before intervention) and immediately after 8 weeks of intervention (post-test). Method of measurement: Active Straight Leg Raise (ASLR) test - participant lies supine and is asked to actively lift one leg straight up without bending the knee; the quality and ease of movement are scored on a 6-point scale (0-5) where 0 indicates no difficulty and 5 indicates impossible to perform; both legs are assessed separately. Health-related quality of life. Timepoint: Baseline (before intervention) and immediately after 8 weeks of intervention (post-test). Method of measurement: Short Form Health Survey (SF-36) - a 36-item validated questionnaire assessing physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health; each domain scored 0-100, with higher scores indicating better quality of life. Fear of movement. Timepoint: Baseline (before intervention) and immediately after 8 weeks of intervention (post-test). Method of measurement: Tampa Scale for Kinesiophobia (TSK) - a 17-item validated questionnaire assessing fear of movement and (re)injury; each item scored 1-4; total score ranges from 17 to 68, with higher scores indicating greater fear of movement. University of Sistan and Baluchistan Approved 2026-06-16 Ethics Committee of the University of Sistan and Baluchestan University Blvd., University of Sistan and Baluchestan, Zahedan, Sistan and Baluchestan Province, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)