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IRCT20210911052440N1 IRCT 2022-02-25 Artesh University of Medical Sciences Effect of Otago Exercise in Sleep Quality, Fatigue and dialysis adequacy Effectiveness of Otago Exercise on Sleep Quality, Fatigue and dialysis adequacy in Hemodialysis Patients 2021-11-04 anticipated 44 Complete https://irct.ir/trial/58681 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Eligible patients based on inclusion criteria in the random allocation method using variable block method (if A: intervention group, B: control group, there will be six different modes for 4 blocks: 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB (blocks that can be written on paper and removed from the bag) will be distributed in two groups. In this way, after explaining the method and objectives of the study to patients and, if necessary, their families and obtaining their informed consent, they are randomly assigned to two groups of intervention and control. Thus, the first patient will be in the intervention group and the second patient in the control group and will be observed in the same way until the last patient. N/A Condition 1: Adequacy of dialysis. Condition 2: Sleep quality of dialysis patients. Condition 3: Fatigue of dialysis patients. Intervention 1: Intervention group: In the intervention group, first home exercise movements Otago will be taught face-to-face once or twice by the researcher to the patient and his / her companion in the hemodialysis ward to ensure complete learning (performing flawless exercise in front of the researcher). The film, the Otago Sports Training Booklet, and the researcher's mobile number will then be provided to clients for possible questions. The clients of the intervention group and their companions will be explained that this exercise should be performed by the clients undergoing hemodialysis according to the schedule, including 8 weeks and three sessions per week and one hour each day on non-hemodialysis days under the supervision of a family member.In addition, the researcher will follow the exercise through face-to-face, mobile phone, SMS and cyberspace. Intervention 2: Control group: The control group does not receive any intervention. Only at the beginning and end of the research, they are asked about demographic information and questionnaire questions. At the end of the intervention, the questionnaires in both groups will be completed and analyzed again.In addition, after the intervention, educational booklets and videos will be provided to the clients of the control group. 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 Hamid Beig Mohammadi
Tehran. West Fatemi Street. End of Etemadzadeh Street.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8802 8350 hamid.f4b@gmail.com Artesh University of Medical Sciences scientific Affat Afaqi
Tehran. West Fatemi Street. End of Etemadzadeh Street
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8820 8350 afaghi8181@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years and under 75 years At least 6 months of hemodialysis treatment Do dialysis twice or more a week Absence of acute infection Lack of musculoskeletal disorders such as multiple sclerosis, heart failure and severe respiratory Absence of chronic inflammatory disease of unknown origin Ability to perform sports movements based on the patient's own statements Do not take sleeping pills, sedatives 18 years 75 years Both Identification of any of the problems and diseases mentioned in the inclusion criteria during the study Reluctance to continue cooperation Failure to perform the desired exercise program for three sessions Rehabilitation Diagnosis Intervention group: In the intervention group, first home exercise movements Otago will be taught face-to-face once or twice by the researcher to the patient and his / her companion in the hemodialysis ward to ensure complete learning (performing flawless exercise in front of the researcher). The film, the Otago Sports Training Booklet, and the researcher's mobile number will then be provided to clients for possible questions. The clients of the intervention group and their companions will be explained that this exercise should be performed by the clients undergoing hemodialysis according to the schedule, including 8 weeks and three sessions per week and one hour each day on non-hemodialysis days under the supervision of a family member.In addition, the researcher will follow the exercise through face-to-face, mobile phone, SMS and cyberspace. Control group: The control group does not receive any intervention. Only at the beginning and end of the research, they are asked about demographic information and questionnaire questions. At the end of the intervention, the questionnaires in both groups will be completed and analyzed again.In addition, after the intervention, educational booklets and videos will be provided to the clients of the control group. Adequacy of dialysis. Timepoint: Measurement of dialysis adequacy at the beginning of the study (before the intervention) and 8 weeks after the start. Method of measurement: According to the patient's tests and the use of two formulas Kt / V and URR. Sleep quality of dialysis patients. Timepoint: Measurement of sleep quality at the beginning of the study (before the intervention) and 8 weeks after the start. Method of measurement: Pittsburgh Sleep Quality Inventory (PSQI). Fatigue of dialysis patients. Timepoint: Measurement of fatigue at the beginning of the study (before the intervention) and 8 weeks after the start. Method of measurement: Multidimensional Fatigue Questionnaire MFI-20. Artesh University of Medical Sciences Approved 2021-06-26 Ethics Committee of Army University of Medical Sciences Tehran-West Fatemi St.-End of Etemadzadeh St. Tehran Tehran Iran (Islamic Republic of)