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IRCT20131117015426N7 IRCT 2019-06-17 Shiraz University of Medical Sciences Otago Exercise Program & Balance The effect of otago exercise program on balance and fear of falling in the elderly 2018-10-05 anticipated 88 Complete https://irct.ir/trial/34428 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the present clinical trial, random allocation of the participants is done via permuted block randomization. Accordingly, A and B represent the individuals receiving and not receiving the intervention, respectively. This method is run on 22 blocks in four permutations by considering all possible quadruple permutations (ABBA, ABAB, AABB, BBAA, BAAB, and BABA) and assigning a code between 0 and 9 (based on the table of random numbers) to each permutation (AABB, code 0; ABAB, code 1; ABBA, code 2; BAAB, code 3; BBAA, code 4; and BABA, codes 5-9). Then, based on the table of random numbers, a starting point is randomly selected, 12 digits are randomly chosen (in a row or column), and the permutation assigned to each digit is written down. It should be noted that the permutations are placed next to each other from left to right. Afterwards, allocation of the 88 participants to groups A and B is determined. N/A Condition 1: Imbalance. Condition 2: Fear of falling. Intervention 1: Intervention group: A group of Otago exercise program is trained by weekly program (twice a week) under the supervision of the trainer and for 30 minutes per session for Intervention group. The intervention program will include 8 training sessions in a month and then continues on exercise at home and will be followed up by phone for 2 months. This intervention is carried out under the supervision of a physiatrist. Intervention 2: Control group: Participants in this group are on the waiting list and do not receive comparative sport education intervention. 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 Due to the informed consent of patients to participate in the study, sharing of this data isn't forbidden. However, no decision has yet been made on sharing.
public Maryam Hazrati
Hazrat Fatemeh School of Nursing and Midwifery , Namazi Hospital ,Namazi Square , Shiraz
Shiraz Iran (Islamic Republic of) 13119–71936 +98 71 3647 4287 hazratim@sums.ac.ir Shiraz University of Medical Sciences scientific Maryam Hazrati
Hazrat Fatemeh School of Nursing and Midwifery,Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) 13119–71936 +98 71 3647 4287 hazratim@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 60 years and older Earning a score of 45 or lower in a Berg's equilibrium test (represents an average and downward balance of the elderly.) Not affiliated with auxiliary equipment such as walker and cane To earn a score of 22 up in the cognitive examination exam (indicates a lack of cognitive impairment in the elderly). Earn score 32 in the disability-induced disorder questionnaire (indicating no dizziness imbalance). 60 years no limit Both Unwillingness to cooperate in research Having defective vision or disabling hearing Having a disabling neurological and muscular disorder that can lead to inability to do daily activities. Neurological disorders or defective disabling of the nervous system Having debilitating vascular diseases Use of medications that may affect the balance of the person, including benzodiazepines, barbiturates, antidepressants, antihistamines, antipsychotics and other sedative and hypnotic tablets Rehabilitation Behavior Intervention group: A group of Otago exercise program is trained by weekly program (twice a week) under the supervision of the trainer and for 30 minutes per session for Intervention group. The intervention program will include 8 training sessions in a month and then continues on exercise at home and will be followed up by phone for 2 months. This intervention is carried out under the supervision of a physiatrist. Control group: Participants in this group are on the waiting list and do not receive comparative sport education intervention. Balance score in Berg's balance scale. Timepoint: Before and after the intervention. Method of measurement: Berg's Balance Scale. Fear of falling score in Falling Efficiency Scale-International. Timepoint: Before and after the intervention. Method of measurement: Falling Efficiency Scale-International. Shiraz University of Medical Sciences Approved 2018-09-28 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)