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IRCT20170925036390N1 IRCT 2017-12-03 Shiraz University of Medical Sciences The effect of Yoga on women with post mastectomy Lymphedema The effect of Yoga exercise on quality of life and arm volume in women with post mastectomy Lymphedema 2017-12-16 anticipated 40 Complete https://irct.ir/trial/27217 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Samples will select according to study inclusion criteria and based on the target. Then they are randomly assigned to two groups using a random number table by block randomization method. First, researcher assistant writes all of the permutations A (representing the intervention group) and B (representing the control group), which consists of 6 different modes. Then, to allocate individuals with random number table, the finger moves randomly from a random point table to the row or column. If the number is between one and six, the permutation of that number is noted. For example, if the number 6 arrives, we will record ABAB permutations, and thus eligible patients will be in the control group and in the intervention group (yoga practice group), Blinding description: This study will be performed in Double blind method so that the first researcher assistant contributes to the initial selection of patients, the completion of the questionnaire and random allocation, so the participants, investigator and even the care providers are unaware of the study groups. In this way, at the times of arm volume control and completing the questionnaire, the participants will not have any information about the allocation of the groups. Data will be imported and analyzed by a non-informed data analyzer, and ultimately the results of the final analysis will be communicated to the researchers. N/A Postmastectomy lymphoedema syndrome. Intervention 1: The intervention of this study is yoga exercise for 8 weeks( 3 sessions in each week ). Two sessions of the weekly schedule will held in one hour at clinic training hall and under the supervision of the trained person and one session of it at home by pat. Intervention 2: The observation group will receive standardize routine care of lymphedema clinic and will evaluate at three time steps. Undecided - It is not yet known if there will be a plan to make this available
public Nazanin Barshan Tashnizi
Iran, Shiraz, Namazi Square, School of Nursing and Midwifery, Shiraz
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3628 9487 nbarshan72@gmail.com Shiraz University of Medical Sciences scientific Dr. Niloofar Pasyar
School of Nursing and Midwifery, Namazi, Square Shiraz University of Medical Sciences Shiraz University of Medical Sciences Fars
shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 npasyar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Having tendency to participate in the research Having the ability to communicate verbally for cooperation Women with secondary upper limb Lymphedema followed by mastectomy confirmed by the clinician Possibility to use DVD at home Ability to move independently without the need for auxiliary equipment At least one year interval from mastectomy surgery to entering the research 18 years 85 years Female Unwillingness to cooperate Establishing any condition that can lead to exacerbation of illness or hospitalization The history of congestive heart failure or chronic obstructive pulmonary disease Patients under chemotherapy or radiotherapy Having pacemaker Pregnancy I97.2 Postmastectomy lymphoedema syndrome Rehabilitation Rehabilitation The intervention of this study is yoga exercise for 8 weeks( 3 sessions in each week ). Two sessions of the weekly schedule will held in one hour at clinic training hall and under the supervision of the trained person and one session of it at home by pat The observation group will receive standardize routine care of lymphedema clinic and will evaluate at three time steps. Quality of Life. Timepoint: at baseline, 4 weeks, and 8 weeks after the intervention. Method of measurement: a specific quality of life assessment questionnaire for cancer patients. Arm volume. Timepoint: at baseline, 4 weeks, and 8 weeks after the intervention. Method of measurement: water displacement volumeter. Shiraz University of Medical Sciences Approved 2017-09-23 Shiraz University of Medical Sciences Shiraz, Zand Avenue, Central Building of the University of Medical Sciences shiraz Fars Iran (Islamic Republic of)