Comparison of the effects of aerobic exercise combined with routine physiotherapy management versus routine physiotherapy alone on grip strength, limb volume, quality of life, and physical function in patients with upper limb lymphedema secondary to breast cancer

Assessing the effect of adding aerobic exercises to standard physiotherapy management on lymphedema volume, grip strength, quality of life, and physical function in patients with upper limb lymphedema due to breast cancer.

A randomized, controlled, double-blind, parallel-group, phase 2 clinical trial with 64 participants; randomization performed using the RAND function in Excel.

Tehran Specialized Physiotherapy Center; double-blind clinical trial (participants and assessors blinded to group allocation). The 8-week intervention includes aerobic exercises (treadmill or cycling; 3 sessions/week, 30 minutes each, mild to moderate intensity) plus two-phase complete decongestive therapy (CDT): Phase 1 (2 weeks in clinic) — manual lymphatic drainage, bandaging, exercises, skin care; Phase 2 (6 weeks at home) — compression garments, exercises, self-care. Control group receives CDT only. Outcomes assessed at baseline, 8 weeks, and 12 weeks.

Inclusion criteria: Women with upper limb lymphedema due to breast cancer؛ Referred by a physician؛ Less than 6 months since completing adjuvant treatments؛ Exclusion criteria:؛ History of bilateral mastectomy؛ Metastatic cancer؛ Severe cardiac, pulmonary, or liver diseases؛ Severe physical or mental disabilities؛ Unwillingness to participate in the study

Intervention group: combination of aerobic exercises and complete decongestive therapy (CDT); Control group: CDT only, similar to the intervention group.

Upper limb volume change: tape measure at specific points and converted to volume by standard formulas (mL); grip strength: handheld dynamometer model dynamometer hydraulic 1J5030 JAMAR (Newtons); quality of life: score of EORTC QLQ-C30 questionnaire; physical function: distance covered in six-minute walk test (meters).

In this study, simple randomization was performed. The unit of randomization was the individual participant, meaning each eligible participant was independently assigned to one of two groups. Stratified randomization was not used in this study. The randomization sequence was generated using a random number table created by the RAND function in Microsoft Excel. Based on this sequence, eligible participants were allocated to either the intervention or control group. To ensure allocation integrity, allocation concealment was implemented; participants and outcome assessors were blinded to group assignments. This procedure minimized the risk of selection bias during group allocation.

To minimize potential biases, the principal investigator, who is also responsible for outcome assessment, will remain blinded to the group allocation of participants throughout the study. Interventions will be administered by a trained physiotherapist who is aware of the assigned treatments. This study is designed as a double-blind randomized controlled trial, where both the participants and the outcome assessor are unaware of the group assignments. Such blinding is implemented to reduce performance and detection biases during data collection and analysis.

The shared data include all demographic, clinical, and outcome information collected during the study, which have been anonymized by removing all personal identifiers and any information that could potentially identify participants. The entire dataset is potentially available for sharing unless there are ethical or legal restrictions prohibiting its release. In some cases, only data related to the primary study outcomes may be shared. All requests for data access will be reviewed and approved by the research ethics committee. Data will be shared under controlled conditions to ensure confidentiality and protect participant rights.

The data and related documents will be made available starting six months after the publication of the main study results.

Access to the study data and documents will be granted exclusively to qualified and authorized researchers affiliated with academic institutions, research centers, or reputable scientific organizations who submit a valid and written request. All requests will be carefully reviewed by the principal investigator and the research ethics committee, and, subject to confidentiality and ethical standards, data access will be provided only upon final approval.

In addition to the eligibility criteria outlined above, applicants requesting access to anonymized individual participant data and other study documents must also comply with the following terms and conditions: Purpose of Use: The data and documents shall be used solely for research purposes related to the objectives of the study. Any use beyond the authorized scope is strictly prohibited. Permitted Analyses: Conducting statistical analyses and research methods directly aligned with the study objectives is permitted. Use of the data for secondary analyses or independent research projects requires submission of a separate research proposal and official approval. Confidentiality: All users are obligated to maintain the confidentiality of the data and documents and must not share them with third parties without written permission from the principal investigator or the research ethics committee. Reporting and Citation: Any publications resulting from the use of the shared data and documents must appropriately acknowledge the original study and investigators. Oversight Mechanism: All requests must include a written research proposal, ethics committee approval, and a commitment to adhere to ethical standards and confidentiality. The principal investigator and ethics committee reserve the right to reject or limit access. Time and Legal Restrictions: Data usage is subject to specified timeframes and applicable legal regulations concerning privacy protection.

Applicants seeking access to the research data and documents are required to submit their requests through authorized individuals or official channels. Accordingly, the access methods and relevant contact information are provided below in order of priority: 1. Full Name of Responsible Person: Sara Vasheghani Farahani Postal Address: No. 226, Kazemi Street, End of Jeyhoun Street, Unit 2, Tehran, Iran Postal Code: 1357644344 Landline: +98 21 5576 0223 Mobile: +98 912 844 2956 Email: vfsara1375@gmail.com 2. Vice-Chancellery for Research and Technology, Semnan University of Medical Sciences Name: Dr. Abbasali Vafaee Postal Address: Basij Boulevard, opposite Soukan Park, Campus No. 1 – Central Headquarters, Semnan University of Medical Sciences and Health Services, Semnan, Iran Postal Code: 35131-19111 Phone: +98 23 3345 1336 Email: info@semums.ac.ir

Applicants seeking access to the research data or documentation must submit a formal written request, including a clear explanation of the intended use and type of analysis to be performed, to the principal investigator via email. Upon receipt, the request will first undergo an initial review by the principal investigator. If necessary, additional documentation or clarification may be requested from the applicant. The request will then be referred to the Research Ethics Committee for final evaluation. If approved, the requested data will be shared in a de-identified format, ensuring full compliance with ethical standards and data confidentiality. The estimated time required to review and respond to requests is approximately 3 to 6 weeks, depending on the circumstances.