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

The effect of 8 weeks of combined aquatic and Pilates training on pain, mobility, functional disability, and quality of life in women with mild to moderate lumbar disc herniation

Clinical trial with control group, with parallel groups, single-blind, random, phase 3 on 45 patients. The Rand Function of the Excel software was used for randomization.

This study was a single-blind randomized clinical trial conducted on women with mild to moderate lumbar disc herniation at Pardisan Sports Center in Tehran, Iran. The assessors and the statistician responsible for data analysis were blinded to group allocation.

Inclusion Criteria: Female gender; Mild to moderate lumbar disc herniation; Exclusion Criteria: Withdrawal of consent or unwillingness to continue participation; Exacerbation of pain during the intervention period

The statistical sample of the present study included women with mild to moderate lumbar disc herniation, from whom 45 people who met the inclusion criteria were selected purposefully and were divided by simple randomization into three groups of 15 people: control, aquatic exercise, and combined aquatic and Pilates exercise. The control group performed their daily routines. The aquatic exercise group, aquatic exercise program, and combined group performed Pilates exercises in addition to the aquatic exercise program.

Low back pain intensity at rest and activity; Lumbar spine flexion range of motion; Functional disability; Quality of life

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.

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.

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

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.

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.

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

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.

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.