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IRCT20251111067956N1 IRCT 2026-06-20 The University of Isfahan Effect of Otago exercises on patients with MS EOEM Effect of Otago exercises on some functional characteristics, fear of falling and quality of life in female patients with MS 2024-10-03 anticipated 28 Complete https://irct.ir/trial/89179 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is low-cost and can be performed anywhere for MS patients, improving their quality of life, Randomization description: A total of 28 women with multiple sclerosis referred to the Isfahan MS Association, aged 20 to 55 years and with an Expanded Disability Status Scale (EDSS) score of 4-1, were randomly assigned to two groups of 14 (experimental and control) based on their EDSS scores. N/A Multiple sclerosis. Intervention 1: Experimental group: 14 women with multiple sclerosis referred to the Isfahan MS Association in the age range of 20 to 55 years and with an Expanded Disability Status Scale (EDSS) score of 4-1 were selected as available and then placed in a 14-person (experimental) group based on the EDSS score. The Otago exercise protocol was designed with four levels of difficulty from easy to difficult and was performed by the patients in the experimental group 3 sessions per week for 45 minutes for 8 weeks. These exercises included balance, strengthening, stretching, and aerobic exercises. Aerobic exercises were walking, which was performed once a week for 10 minutes. Before the start of the study, exercises were performed on three patients and the exercises were written in a modified form according to the patients' abilities, and these three patients were excluded from the study and did not enter the experimental group. Some exercises were performed by attaching weights to the feet, and the amount of weights was increased during the two months of performing the exercises. The weights were increased by half a kilo every two weeks, with half a kilo being used in the first and second weeks and two kilos in the seventh and eighth weeks. To increase the load, in addition to adding the amount of weights, the number of times each exercise was performed was increased. Before and after the training intervention, the variables of static balance, dynamic balance, cardiorespiratory endurance, neuromuscular function, range of motion, proprioception, muscle strength, quality of life, fatigue, fear of falling, and fear of movement were evaluated, respectively, through the functional access test, time to get up and go, 6 minutes of walking, and 30 seconds of sitting and getting up from a chair, goniometer, dynamometer, 54-question quality of life questionnaire, MFIS questionnaire, FSI questionnaire, and Tampa questionnaire for patients with multiple sclerosis. Data analysis was performed using analysis of variance for repeated measures. The significance level was accepted at a 95% confidence level. Intervention 2: Control group: 14 women with multiple sclerosis referring to the Isfahan MS Association, aged 20 to 55 years and with an Expanded Disability Status Scale (EDSS) score of 4-1, were selected through convenience sampling and then placed in a group of 14 (control) based on their EDSS score. These patients continued their normal lives, including taking medications and daily activities, except for participating in rehabilitation, occupational therapy, and exercise training. Before and after the training intervention, the variables of static balance, dynamic balance, cardiorespiratory endurance, neuromuscular function, range of motion, proprioception, muscle strength, quality of life, fatigue, fear of falling, and fear of movement were evaluated, respectively, through the functional access test, time to get up and go, 6-minute walk, and 30-second sitting and standing from a chair, goniometer, dynamometer, 54-item quality of life questionnaire, MFIS questionnaire, FSI questionnaire, and Tampa questionnaire for patients with multiple sclerosis. Data analysis was performed using analysis of variance for repeated measures. The significance level was accepted at a 95% confidence level. Yes - There is a plan to make this available What will be shared: Only a portion of the data can be shared anonymously. When: After 6 months To whom: Researchers only Conditions: Repeated measures analysis Where to obtain: Researcher conducting research How to obtain: By sending a request email to raziehamini1996@gmail.com Comments:
public Gholamali Ghasemi
Azadi
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 913 129 9817 Gh.ghasemi@spr.ui.ac.ir The University of Isfahan scientific Gholamali Ghasemi
Azadi
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 31 3793 2128 Gh.ghasemi@spr.ui.ac.ir The University of Isfahan Iran (Islamic Republic of) MS (as diagnosed by a neurologist) An Expanded Disability Status Scale (EDSS) score of 1-4 Women with MS aged 20-55 years They are not pregnant They have a history of falling for at least the past two years. 20 years 55 years Female Having other neuromuscular diseases Pregnant G35 Multiple sclerosis Rehabilitation Rehabilitation Experimental group: 14 women with multiple sclerosis referred to the Isfahan MS Association in the age range of 20 to 55 years and with an Expanded Disability Status Scale (EDSS) score of 4-1 were selected as available and then placed in a 14-person (experimental) group based on the EDSS score. The Otago exercise protocol was designed with four levels of difficulty from easy to difficult and was performed by the patients in the experimental group 3 sessions per week for 45 minutes for 8 weeks. These exercises included balance, strengthening, stretching, and aerobic exercises. Aerobic exercises were walking, which was performed once a week for 10 minutes. Before the start of the study, exercises were performed on three patients and the exercises were written in a modified form according to the patients' abilities, and these three patients were excluded from the study and did not enter the experimental group. Some exercises were performed by attaching weights to the feet, and the amount of weights was increased during the two months of performing the exercises. The weights were increased by half a kilo every two weeks, with half a kilo being used in the first and second weeks and two kilos in the seventh and eighth weeks. To increase the load, in addition to adding the amount of weights, the number of times each exercise was performed was increased. Before and after the training intervention, the variables of static balance, dynamic balance, cardiorespiratory endurance, neuromuscular function, range of motion, proprioception, muscle strength, quality of life, fatigue, fear of falling, and fear of movement were evaluated, respectively, through the functional access test, time to get up and go, 6 minutes of walking, and 30 seconds of sitting and getting up from a chair, goniometer, dynamometer, 54-question quality of life questionnaire, MFIS questionnaire, FSI questionnaire, and Tampa questionnaire for patients with multiple sclerosis. Data analysis was performed using analysis of variance for repeated measures. The significance level was accepted at a 95% confidence level. Control group: 14 women with multiple sclerosis referring to the Isfahan MS Association, aged 20 to 55 years and with an Expanded Disability Status Scale (EDSS) score of 4-1, were selected through convenience sampling and then placed in a group of 14 (control) based on their EDSS score. These patients continued their normal lives, including taking medications and daily activities, except for participating in rehabilitation, occupational therapy, and exercise training. Before and after the training intervention, the variables of static balance, dynamic balance, cardiorespiratory endurance, neuromuscular function, range of motion, proprioception, muscle strength, quality of life, fatigue, fear of falling, and fear of movement were evaluated, respectively, through the functional access test, time to get up and go, 6-minute walk, and 30-second sitting and standing from a chair, goniometer, dynamometer, 54-item quality of life questionnaire, MFIS questionnaire, FSI questionnaire, and Tampa questionnaire for patients with multiple sclerosis. Data analysis was performed using analysis of variance for repeated measures. The significance level was accepted at a 95% confidence level. Static balance. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Forward Functional Reach (FFR). Dynamic balance. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Timed Up & Go (TUG). Cardiorespiratory endurance. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: 6 minutes walk test. Neuromuscular function. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: 30 Seconds Sit To Stand Test. Knee proprioception. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Goniometer. Range of motion. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Goniometer. Muscular strength. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Dynamometer. Fear of falling. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Questionnaire Falls Efficacy Scale- International. Fear of movement. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Questionnaire TSK. Fatigue. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Questionnaire MFI. Quality of life. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Questionnaire Multiple Sclerosis Quality of Life-54 (MSQOL-54). The University of Isfahan Approved 2024-09-14 Ethics Committee of the University of Isfahan Parvin etesami street, Alley 15 Farsan Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)