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IRCT20230816059172N1 IRCT 2023-09-13 Tehran University of Medical Sciences Resistive exercise in lymphedema Comparing the Effect of Combined Decongestive Therapy with or without Resistive Exercises on Edema Volume, Upper Limb Function, and Quality of Life among Women with Breast Cancer Related Lymphedema 2023-09-23 anticipated 38 Complete https://irct.ir/trial/72208 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants will be randomized by block balance randomization. They will be sorted by blocks of 4 into two groups. Sequence of blocks will be made by Randomization website, Blinding description: The patients will be unaware of their group allocation. The assessor will be unaware of which group the participanthas been allocated. N/A Breast cancer related lymphedema. Intervention 1: Intervention group: Combined decongestional therapy which consists of compression bandage, skin and nail care, manual lymph drainage and exercise therapy will be performed for 10 sessions and 5 days per week. The participants will also perform 6 sessions of resistive exercise concurrently. Intervention 2: Control group: Combined decongestional therapy which consists of compression bandage, skin and nail care, manual lymph drainage and exercise therapy will be performed for 10 sessions and 5 days per week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Aisan Seyedi
School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 seyyedia1@gmail.com Tehran University of Medical Sciences scientific Aisan Seyedi
School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 seyyedia1@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women with breast cancer who had undergone needed treatments Patients who had finished their chemotherapy or radiotherapy at least 6 weeks ago Native Iranians or people who can read and write persian Patients with lymphedema diagnosis with one of these conditions: 1- At least 2 centimeters difference in upper limbs' circumference; 2-At least 200 milliliters difference in upper limbs' volume; 3- At least 5 percent difference in upper limbs' volume no limit no limit Female Cancer recurrence Untreated heart or kidney failure People experiencing joint or muscle pain while doing active movements without resistence Uncontrolled infection Deep vein thrombosis in upper limb Inflammatory neuromuscular disease Coronary artery disease Congestive heart failure People who are unable to understand commands People who are unable to participate in physiotherapy Uncontrolled hypertension I97.2 Postmastectomy lymphedema syndrome Treatment - Other Treatment - Other Intervention group: Combined decongestional therapy which consists of compression bandage, skin and nail care, manual lymph drainage and exercise therapy will be performed for 10 sessions and 5 days per week. The participants will also perform 6 sessions of resistive exercise concurrently. Control group: Combined decongestional therapy which consists of compression bandage, skin and nail care, manual lymph drainage and exercise therapy will be performed for 10 sessions and 5 days per week. Quality of life. Timepoint: Before starting the intervention and at the end of treatment period. Method of measurement: Lymphedema life impact scale questionnaire. Upper limb function. Timepoint: Before starting the intervention and at the end of treatment period. Method of measurement: Performing Upper limb functional test and dexterity test. Upper limb circumference. Timepoint: Before starting the intervention and at the end of treatment period. Method of measurement: Measuring tape. Upper limb volume. Timepoint: Before starting the intervention and at the end of treatment period. Method of measurement: Measuring tape and calculator. Tehran University of Medical Sciences Approved 2023-08-16 Ethics committee of Tehran University of Medical Sciences School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran Tehran Tehran Iran (Islamic Republic of)