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IRCT20221009056124N1 IRCT 2023-01-30 Ahvaz University of Medical Sciences The effect of adding respiratory physiotherapy to common physiotherapy on patients with lymphedema The effect of‏ ‏conventional physical therapy with and without ‎breathing pattern correction exercises on pain, range of motion, size, ‎volume of the swollen limb, respiratory parameters and quality of life ‎in patients with breast cancer related lymphedema (BCRL)‎ 2022-11-12 anticipated 40 Complete https://irct.ir/trial/66262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects are randomly divided into two groups using block randomization in individual units. Randomization is done using Random Allocation software (version 1.1, Isfahan University of Medical Sciences, Iran) by a statistician who has no role in the study. A random order of two words A (intervention) and B (control) will be made in blocks with random numbers of 4 and 6. Then another person puts them in a sealed envelope. Before starting the intervention, one of the envelopes will be opened and thus the person will be placed in one of the two groups, Blinding description: This is a double-blind clinical trial in which patients are evaluated by another physiotherapist who is unaware of assigning individuals to groups. Data analysis is done by a person who is unaware of assigning individuals to groups. N/A Upper limb lymphedema after breast cancer. Intervention 1: Control group: The Complete Decongestive Therapy of lymphedema is given to the patient which includes: Manual lymphatic Drainage , exercises (stretching and proprioceptive neuromuscular facilitation that repeats in 3 sets of 10 times), skin care and garment (compression sleeve). 12 treatment sessions (4 treatment weeks with a frequency of 3 times a week) and in each session 30 minutes of lymphatic massage and 10 minutes of exercise are performed. Intervention 2: Intervention group: The Common treatment of lymphedema is given to the patient along with the correction of the breathing pattern. 12 treatment sessions (4 weeks of treatment with a frequency of 3 times a week) and each session includes 30 minutes of lymphatic massage and 10 minutes of exercise. The treatment for correcting the breathing pattern includes: breathing exercises (3 diaphragmatic breathing exercises, chest mobilization and butterfly breathing technique) in all sessions 10 times and the person will be taught how to do it at home. In patients who suffer from surgery (chest surgery), the movement of the ribs is limited, the rhythm of breathing is affected, and accessory muscles replace the main muscles. For this reason, one of the essential treatments is diaphragmatic breathing training, exercise to facilitate chest movement and improve breathing pattern. These exercises do not require equipment, they are taught by the therapist, and the patient will perform them at home in addition to the treatment session. Yes - There is a plan to make this available What will be shared: Information on outcomes to be assessed is available after publication of the results. When: Access will begin 6 months after publication of the results To whom: Researchers working in academic and scientific institutions Conditions: After publication the results, the data will be used to find a better way to treat lymphedema Where to obtain: Arefe Fattah, Fattaha69@gmail.com How to obtain: When the requester needs the data, she sends an email to Arefe Fattah and receives it if possible. Comments:
public Arefe Fattah
No.15, 16, Emam Khomeini Ave, Qaen Town
Qaen Iran (Islamic Republic of) ‎9761873180‎ +98 56 3252 2217 fattaha69@gmail.com Ahvaz University of Medical Sciences scientific Arefe Fattah
No.15, 16, Emam Khomeini Ave, Qaen Town
Qaen Iran (Islamic Republic of) ‎9761873180‎ +98 56 3252 2217 fattaha69@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with breast cancer who had axillary lymph node surgery with and without radiotherapy or taxane chemotherapy or unilateral mastectomy First-degree unilateral lymphedema according to the lymphology assembly Age 32 to 80 years Body mass index less than 30 The difference in the measured points between two organs should be between 2 and 8 cm at least in one point of the organ 32 years 80 years Female Infection in the operated area Lymphatic vessel inflammation or deep vein occlusion History of chronic respiratory disease Receiving other treatments at the same time as the study treatment I97.2 Postmastectomy lymphedema syndrome Rehabilitation Rehabilitation Control group: The Complete Decongestive Therapy of lymphedema is given to the patient which includes: Manual lymphatic Drainage , exercises (stretching and proprioceptive neuromuscular facilitation that repeats in 3 sets of 10 times), skin care and garment (compression sleeve). 12 treatment sessions (4 treatment weeks with a frequency of 3 times a week) and in each session 30 minutes of lymphatic massage and 10 minutes of exercise are performed. Intervention group: The Common treatment of lymphedema is given to the patient along with the correction of the breathing pattern. 12 treatment sessions (4 weeks of treatment with a frequency of 3 times a week) and each session includes 30 minutes of lymphatic massage and 10 minutes of exercise. The treatment for correcting the breathing pattern includes: breathing exercises (3 diaphragmatic breathing exercises, chest mobilization and butterfly breathing technique) in all sessions 10 times and the person will be taught how to do it at home. In patients who suffer from surgery (chest surgery), the movement of the ribs is limited, the rhythm of breathing is affected, and accessory muscles replace the main muscles. For this reason, one of the essential treatments is diaphragmatic breathing training, exercise to facilitate chest movement and improve breathing pattern. These exercises do not require equipment, they are taught by the therapist, and the patient will perform them at home in addition to the treatment session. Pain. Timepoint: Before, immediately and one month after the treatment. Method of measurement: Visual Analog Scale. Circumference size of upper limb. Timepoint: Before, immediately and one month after the treatment. Method of measurement: meter. Vital Capacity of breathing(VC) (Volumetric lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: Spirometer. Forced Vital Capacity of breathing(FVC) (Volumetric lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: Spirometer. Breathing Forced Expiratory Volume in First second(FEV1) (Volumetric lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: Spirometer. End-expiratory carbon dioxide concentration(End Tidal CO2) (biochemical lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: capnograph. Arterial oxygen concentration(PaO2) (biochemical lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: capnograph. Respiratory rate (biochemical lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: capnograph. Arterial carbon dioxide pressure(PaCO2) (biochemical lung function test). Timepoint: Before, immediately and one month after the treatment. Method of measurement: capnograph. Range Of Motion(ROM). Timepoint: Before the intervention, immediately and one month after the end of the intervention. Method of measurement: Goniometer. Quality Of Life(QOL). Timepoint: Before the intervention, immediately and one month after the end of the intervention. Method of measurement: lymphedema life impact scale Questionnaire (LLIS). Ahvaz University of Medical Sciences Approved 2022-07-16 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Ground Floor, Research and Technology Vice-Chancellor of Jundishapur University of Medical Sciences and Healthcare Services, University City, Golestan highway Ahvaz, 061-33333477 Ahvaz Khouzestan Iran (Islamic Republic of)