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IRCT20150919024080N18 IRCT 2020-10-12 Khoram-Abad University of Medical Sciences The effect of balance training on the cognition and daily living of the elderly with heart failure The effect of Balance Training on Cognitive Function and Activity of Daily Living of Elderly People with Heart Failure 2020-08-22 anticipated 88 Complete https://irct.ir/trial/49352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After basic evaluations such as cardiovascular function evaluation tests by a cardiologist, patients are admitted to the study according to the inclusion and exclusion criteria, then by block randomization (Block Randomization) in two groups of treatment and control in a balanced way. Randomization is done using a random number table. In this sampling method, the classes will be based on the New York Heart Association functional class variables and literacy level. Patients will also be matched for age and gender. The sample size is calculated based on the change in the average daily activity or cognitive function of 88 patients with heart failure, of which 44 patients will be in the intervention group and 44 patients in the control group, Blinding description: Studying on both sides will be blind. Patients are unaware that they are in the control or intervention group and are unaware of the research hypothesis. Data collection is done with the help of a researcher who is unaware of the random allocation of groups. Data analysis is also performed by a researcher who is unaware of the random allocation of groups. N/A Elderly patients. Intervention 1: Intervention group: There are 44 patients in this group. Balance exercises in this group will be for 30 minutes every day and four times a week for eight weeks. Each balance exercise is repeated and lasts about 3-5 minutes. One session per week. Supervised by a nurse. The first supervision of the nurse will be during the first session and the next supervisions will be performed once a week with the coordination of the patient. Intervention 2: Control group: There are 44 patients in this group. In this group, no special sports intervention is performed and they receive only the usual care, including period visits by the treating physician. 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 Its release schedule is still unclear
public Faezeh Zahrabi Salari
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
Khorram Abad Iran (Islamic Republic of) 381351698 +98 66 3312 0139 fz.s711@ymail.com Khoram-Abad University of Medical Sciences scientific Mohammad Gholami
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical
Khorram Abad Iran (Islamic Republic of) 381351698 +98 66 3312 0139 mohammad13565@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Class 2 and 3 heart failure based on the diagnosis of the treating physician and the functional class criteria of the New York Heart Association Ability to walk independently and without the use of moving aids (canes and walkers) indoors and outdoors balance impairment (based on the complete tandem standing test in less than 10 seconds) Cognitive dysfunction score below 26 (based on the Montreal Cognitive Functional Disorder Questionnaire) Having a dysfunction in daily activities Gaining a score of 14 from the Barthel questionnaire Ability to make phone calls Lack of restrictive exercises such as visual and auditory impairment Having at least literacy and the ability to understand Persian 60 years 75 years Both Diabetes mellitus and history of hypoglycemic and hyperglycemic attacks Diabetic nephropathy and retinopathy, hypertensive crises History of acute stroke Dementia Peripheral arterial disease End-stage heart failure requires advanced treatment Acute arthropathy or musculoskeletal disorders Participate in other sports programs Rehabilitation Rehabilitation Intervention group: There are 44 patients in this group. Balance exercises in this group will be for 30 minutes every day and four times a week for eight weeks. Each balance exercise is repeated and lasts about 3-5 minutes. One session per week. Supervised by a nurse. The first supervision of the nurse will be during the first session and the next supervisions will be performed once a week with the coordination of the patient. Control group: There are 44 patients in this group. In this group, no special sports intervention is performed and they receive only the usual care, including period visits by the treating physician. Cognitive performance score. Timepoint: Before the intervention, and one week after the 60-day treatment period. Method of measurement: Montreal cognitive assessment- Basic (MOCA_Bp) test. Activity of Daily Living. Timepoint: Before the intervention, and one week after the 60-day treatment period. Method of measurement: Bartel & Lawton Activities of Daily Living scales. Khoram-Abad University of Medical Sciences Approved 2020-06-07 Ethics Committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Lorestan, Khorram Abad, 5 Km. Khorramabad Lorestan Iran (Islamic Republic of)