]>
IRCT20250611066183N1 IRCT 2025-07-04 Semnan University of Medical Sciences Effect of adding aerobic exercise to physiotherapy in lymphedema secondary to breast cancer 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 2025-07-23 anticipated 64 Complete https://irct.ir/trial/84308 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Postmastectomy lymphedema syndrome. Intervention 1: Intervention group: Participants in this group, after a complete evaluation, will simultaneously receive two interventions over a period of 8 weeks under the supervision of an experienced physiotherapist: Aerobic exercise: Participants will perform treadmill walking or cycling at a mild to moderate intensity (50 to 60% of heart rate reserve - HRR) or a Borg scale rating of 7 to 13, 3 sessions per week, each session lasting 30 minutes. Each session includes 5 minutes of warm-up, 20 minutes of main aerobic exercise, and 5 minutes of cool-down. The speed, intensity, and duration of the exercise will be gradually increased according to the participants’ exercise capacity. Complete Decongestive Therapy (CDT):This therapy consists of two phases: Phase one (two weeks, 10 sessions in clinic):Participants will receive manual lymphatic drainage (MLD), multi-layer bandaging, limb mobilization exercises, and skin care. The aim of this phase is to maximize the reduction of lymphedema volume, decrease lymphatic fluid congestion, and prevent infection. Phase two (six weeks, maintenance phase at home):Participants will be trained to maintain the reduction in lymphedema volume and prevent recurrence by wearing compression garments, performing skin care, regularly doing exercises, and applying self-lymphatic massage. Intervention 2: Control group: Participants in this group, following a comprehensive initial assessment, will receive Complete Decongestive Therapy (CDT) under the supervision of an experienced physiotherapist for a duration of 8 weeks. This therapy consists of two phases: Phase I (two weeks, 10 sessions at the clinic):Participants will undergo Manual Lymphatic Drainage (MLD), multilayer bandaging, limb mobility exercises, and skin care. The goal of this phase is to achieve maximum reduction in lymphedema volume, decrease lymphatic fluid congestion, and prevent infection. Phase II (six weeks, maintenance phase at home):Participants will be trained to maintain the reduced lymphedema volume and prevent recurrence through self-management techniques, including wearing compression garments, performing regular exercises, maintaining proper skin care, and conducting self-lymphatic massage. Yes - There is a plan to make this available What will be shared: 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. When: The data and related documents will be made available starting six months after the publication of the main study results. To whom: 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. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Sara Vasheghani Farahani
No 226, Kazemi Ave. jeyhoun Street, Tehran
Tehran Iran (Islamic Republic of) 1357644344 +98 21 5576 0223 vfsara1375@gmail.com Semnan University of Medical Sciences scientific Sara Vasheghani Farahani
No 226, Kazemi Ave. jeyhoun Street, Tehran
Tehran Iran (Islamic Republic of) 1357644344 +98 21 5576 0223 vfsara1375@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Women diagnosed with upper limb lymphedema secondary to breast cancer Referred by a physician for participation in the study Less than six months had passed since the end of chemotherapy or radiotherapy treatment for breast cancer Average time elapsed since breast cancer surgery between 5 to 6 months no limit no limit Female History of bilateral mastectomy Metastatic breast cancer Planned breast reconstruction within the next 6 months Severe and unstable cardiac diseases (e.g., decompensated heart failure, unstable ischemic heart disease, moderate to severe valvular heart disease, aortic aneurysm) Moderate to severe chronic obstructive pulmonary disease (COPD) Severe untreated hypertension Pulmonary hypertension and chronic respiratory failure Advanced liver failure Severe anemia (hemoglobin less than 8 g/dL) Severe physical disabilities or mental impairments preventing participation Refusal to cooperate with the study protocol I97.2 This code is specifically used to classify lymphedema as a direct complication of mastectomy (surgical removal of the breast), often due to lymph node removal or damage to lymphatic vessels during the procedure. Rehabilitation Rehabilitation Intervention group: Participants in this group, after a complete evaluation, will simultaneously receive two interventions over a period of 8 weeks under the supervision of an experienced physiotherapist: Aerobic exercise: Participants will perform treadmill walking or cycling at a mild to moderate intensity (50 to 60% of heart rate reserve - HRR) or a Borg scale rating of 7 to 13, 3 sessions per week, each session lasting 30 minutes. Each session includes 5 minutes of warm-up, 20 minutes of main aerobic exercise, and 5 minutes of cool-down. The speed, intensity, and duration of the exercise will be gradually increased according to the participants’ exercise capacity. Complete Decongestive Therapy (CDT):This therapy consists of two phases: Phase one (two weeks, 10 sessions in clinic):Participants will receive manual lymphatic drainage (MLD), multi-layer bandaging, limb mobilization exercises, and skin care. The aim of this phase is to maximize the reduction of lymphedema volume, decrease lymphatic fluid congestion, and prevent infection. Phase two (six weeks, maintenance phase at home):Participants will be trained to maintain the reduction in lymphedema volume and prevent recurrence by wearing compression garments, performing skin care, regularly doing exercises, and applying self-lymphatic massage. Control group: Participants in this group, following a comprehensive initial assessment, will receive Complete Decongestive Therapy (CDT) under the supervision of an experienced physiotherapist for a duration of 8 weeks. This therapy consists of two phases: Phase I (two weeks, 10 sessions at the clinic):Participants will undergo Manual Lymphatic Drainage (MLD), multilayer bandaging, limb mobility exercises, and skin care. The goal of this phase is to achieve maximum reduction in lymphedema volume, decrease lymphatic fluid congestion, and prevent infection. Phase II (six weeks, maintenance phase at home):Participants will be trained to maintain the reduced lymphedema volume and prevent recurrence through self-management techniques, including wearing compression garments, performing regular exercises, maintaining proper skin care, and conducting self-lymphatic massage. Change in upper limb volume (in milliliters), calculated by circumferential measurements at specified points using a measuring tape and converted to volume using standard formulas. Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: To assess the volume of upper limb edema, circumferential measurements are taken at specific points on the limb using a measuring tape. The limb volume is then calculated in milliliters using standardized formulas. Measurement points include the metacarpophalangeal region, mid-metacarpals, wrist, distal quarter of the forearm, mid-forearm, proximal quarter of the forearm, mid-arm, and the axillary line. Grip strength will be measured using a hand-held dynamometer (Hydraulic Hand Dynamometer, Model 1J5030, JAMAR). Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: For grip strength assessment, a handheld dynamometer model dynamometer hydraulic 1J5030 JAMAR will be used. Participants are asked to hold the dynamometer, keep their elbow flexed at 90 degrees and shoulder in a neutral position. Then, they squeeze the dynamometer with maximum effort. This process is repeated three times, and the highest value from each hand will be recorded. The quality of life score of patients was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30). Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: To assess the quality of life of patients, the Persian version (third edition) of the “European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items” (EORTC QLQ-C30) will be used. This self-administered questionnaire consists of 30 items and evaluates the quality of life of cancer patients across five functional domains (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), nine symptom domains (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and one global quality of life domain. Scoring interpretation varies depending on the domain type: higher scores in the functional domains and global health status indicate better quality of life, while higher scores in the symptom domains reflect more severe symptoms. Therefore, improvement is reflected by increased scores in functional domains and decreased scores in symptom domains. Several validation studies conducted in Iran have confirmed the reliability and validity of this tool. For instance, in the study by Kahrizi et al. (2011), Cronbach’s alpha coefficients were reported as 0.65 for fatigue, 0.69 for pain, 0.66 for nausea and vomiting, and above 0.70 for other subscales. In another study by Akbari et al. (2014), Cronbach’s alpha values ranged from 0.68 to 0.79 across different dimensions. Physical performance will be assessed based on the distance walked (in meters) during the Six-Minute Walk Test (6MWT). Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: In this study, the six-minute walk test will be used to assess physical performance. Participants will be instructed to walk back and forth continuously between two markers placed 15 meters apart for six minutes at their maximum possible effort. At the beginning and end of the course, participants will be required to turn around within a 0.5-meter radius circular area. The assessor will provide verbal encouragement every minute to motivate participants to maintain their maximum effort throughout the test. The total distance walked (in meters) during the six minutes will be considered an indicator of the individual’s physical performance. Semnan University of Medical Sciences Approved 2025-06-07 Ethics Committee of Semnan University of Medical Sciences No. 1, Central Headquarters, Semnan University of Medical Sciences, Basij Blvd., Semnan Semnan Semnan Iran (Islamic Republic of)