]>
IRCT20180521039762N2 IRCT 2025-10-01 Payame Noor University The Effect of Aquatic and Pilates Exercises on Pain and Quality of Life in Women with Lumbar Disc Herniation APLD The Effect of Combined Aquatic and Pilates Exercises on Pain, Mobility, Functional Disability, and Quality of Life in Women with Mild to Moderate Lumbar Disc Herniation 2024-09-21 anticipated 45 Complete https://irct.ir/trial/86004 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: In this trial, participants who meet the eligibility criteria and provide informed consent will be randomly assigned to one of the three study groups using simple randomization. A sequential list of all eligible participants will be prepared. Group allocation will then be determined by a computer-generated random sequence (using software such as Random Allocation Software or the RAND function in Microsoft Excel). For each participant, a random number will be generated, and based on this number, the participant will be assigned to one of the three groups. The probability of allocation to each group is equal, and no researcher involvement or bias will influence the randomization process, Blinding description: This study is conducted as a single-blind trial. Participants are aware of their assigned study group, as it is necessary to provide them with sufficient information to adhere to the intervention protocols. However, the researchers administering the interventions are blinded to group allocation, which is managed by an independent researcher. This approach helps minimize bias in the delivery of interventions. 3 Lumbar disc herniation. Intervention 1: First intervention group (Combined Aquatic + Pilates Group): Participants in the combined group followed the same 8-week, thrice-weekly supervised program, with sessions lasting about 60 minutes (10 minutes warm-up, 45 minutes main exercises, 5 minutes cool-down). The 45-minute main segment was divided equally between aquatic exercises (20–25 minutes) and Pilates exercises (20–25 minutes). Each exercise was performed in three sets, with positions held for 10–30 seconds and short recovery periods of 10–20 seconds between sets. Aquatic exercises were performed in the pool under hydrotherapy supervision. Pilates exercises were conducted in a gym hall within the same facility under the supervision of a certified Pilates instructor, with emphasis on breathing control, pelvic-lumbar stabilization, thoracic alignment, shoulder positioning, and head-neck alignment. Intervention 2: Second intervention group (Aquatic Exercise Group): Participants in the aquatic group engaged in an 8-week program consisting of three supervised sessions per week, each lasting approximately 60 minutes (10 minutes warm-up, 45 minutes aquatic exercises, 5 minutes cool-down). A total of 11 aquatic exercises were performed in the pool, with each exercise completed in 3–5 sets, holding positions for 10–30 seconds. Rest intervals of 10–20 seconds were allowed between sets. The intensity and number of repetitions were gradually increased over the course of the program. Sessions took place in an indoor pool (water temperature 31–33 °C) under the supervision of a licensed hydrotherapy instructor. Intervention 3: Control group: Participants in the control group did not receive any structured exercise intervention. They were instructed to continue their usual daily routines and activities without engaging in any additional exercise programs during the study period. To maintain fairness, participants in this group were offered general guidance on safe physical activity after completing the trial. Yes - There is a plan to make this available What will be shared: itle of Data/Documents: Individual Participant Data (IPD) – Women with Mild to Moderate Lumbar Disc Herniation Details: Includes clinical and questionnaire data (pain, mobility, functional disability, quality of life) and physical/laboratory measurements All data are de-identified; no personally identifiable information will be shared All collected data, including primary and secondary outcomes, are potentially shareable for research purposes after de-identification Additional documents: study protocol and statistical analysis plan When: The study data and documents will be available to interested researchers six months after the publication of the main study article and will remain accessible for five years from the start of access. To whom: The study data and documents will be available to interested researchers affiliated with academic and research institutions, as well as independent investigators. Applicants from industry or commercial organizations may also request access, provided that their purpose is strictly scientific research and independent analysis, and they sign a confidentiality agreement and commit to ethical research practices. Conditions: Data and documents are to be used strictly for scientific research and independent analysis. Permitted types of analysis: Any statistical analysis, modeling, or review related to the study topic, provided confidentiality is maintained. Use of documents: Study protocol and statistical analysis plan may be used to understand methodology and conduct independent analyses. Request procedure: Submit a formal request via the study team’s email Complete the data access request form Sign a confidentiality agreement and commit to ethical research practices Request reviewed and approved by the study team and ethics committee prior to access Where to obtain: Applicants interested in accessing study data and documents may proceed as follows: 1. Send a formal email to the corresponding author Email: moghadasi@pnu.ac.ir Contact person: Dr. Afshin Moghadasi 2. Send a postal letter: Department of Sports Injury and Corrective Exercises, Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Iran. Recipient: Dr. Afshin Moghadasi, Corresponding Author 3. Phone for inquiries: Number: +98 918 943 2264 All requests will be reviewed by the corresponding author, and access will be granted after approval and signing of a confidentiality agreement and commitment to ethical research practices. How to obtain: Request process for data/documents: 1. Submit a formal request: The applicant sends a written or email request to the corresponding author. 2. Complete the access form: The applicant fills out the data/documents access request form. 3. Review of the request: The study team and corresponding author review the request to ensure compliance with usage conditions. 4. Ethics committee approval (if required): The ethics committee reviews and approves the request if necessary. 5. Sign confidentiality agreement: The applicant signs a confidentiality agreement and commits to ethical research practices. 6. Access granted: After completing the above steps, access to the data/documents is provided. 7. Follow-up and support: The applicant can contact the corresponding author for guidance or additional information during the process. Comments:
public Afshin Moghadasi
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
Tehran Iran (Islamic Republic of) 193954697 +98 21 2332 0000 moghadasi@pnu.ac.ir Payame Noor University scientific Afshin Moghadasi
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
Tehran Iran (Islamic Republic of) 193954697 +98 21 2332 0000 moghadasi@pnu.ac.ir Payame Noor University Iran (Islamic Republic of) Female gender Age between 30 and 50 years Mild to moderate lumbar disc herniation, diagnosed by an orthopedic specialist and confirmed by MRI report, without indication for surgical intervention Referral and recommendation from a specialist physician for participation in aquatic or exercise-based therapy 30 years 50 years Female No history of other diseases or injuries that are incompatible with exercise No history of surgery Not pregnant M51.06 Intervertebral disc disorders with myelopathy, lumbar region Rehabilitation Rehabilitation Treatment - Drugs First intervention group (Combined Aquatic + Pilates Group): Participants in the combined group followed the same 8-week, thrice-weekly supervised program, with sessions lasting about 60 minutes (10 minutes warm-up, 45 minutes main exercises, 5 minutes cool-down). The 45-minute main segment was divided equally between aquatic exercises (20–25 minutes) and Pilates exercises (20–25 minutes). Each exercise was performed in three sets, with positions held for 10–30 seconds and short recovery periods of 10–20 seconds between sets. Aquatic exercises were performed in the pool under hydrotherapy supervision. Pilates exercises were conducted in a gym hall within the same facility under the supervision of a certified Pilates instructor, with emphasis on breathing control, pelvic-lumbar stabilization, thoracic alignment, shoulder positioning, and head-neck alignment. Second intervention group (Aquatic Exercise Group): Participants in the aquatic group engaged in an 8-week program consisting of three supervised sessions per week, each lasting approximately 60 minutes (10 minutes warm-up, 45 minutes aquatic exercises, 5 minutes cool-down). A total of 11 aquatic exercises were performed in the pool, with each exercise completed in 3–5 sets, holding positions for 10–30 seconds. Rest intervals of 10–20 seconds were allowed between sets. The intensity and number of repetitions were gradually increased over the course of the program. Sessions took place in an indoor pool (water temperature 31–33 °C) under the supervision of a licensed hydrotherapy instructor. Control group: Participants in the control group did not receive any structured exercise intervention. They were instructed to continue their usual daily routines and activities without engaging in any additional exercise programs during the study period. To maintain fairness, participants in this group were offered general guidance on safe physical activity after completing the trial. Pain intensity at rest and activity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual numerical scale. Functional disability. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Oswestry Low Back Pain Disability Questionnaire. Quality of life. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SF-36 Quality of Life Questionnaire. Spinal flexion range of motion. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Modified Modified Schober Test. Pain intensity at rest and activity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual numerical scale. Functional disability. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Oswestry Low Back Pain Disability Questionnaire. Quality of life. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SF-36 Quality of Life Questionnaire. Range of motion of lumbar flexion. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Modified Modified Schober Test. Payame Noor University Approved 2024-09-13 Research Ethics Committees of Payame Noor University Payame Noor University, Nakhl St., Artesh Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)