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IRCT20200611047727N2 IRCT 2020-07-07 Shahid Beheshti University of Medical Sciences Investigation of IMT effect in ALS patients The effect of Inspiratory muscle training compared with diaphragmatic breathing in respiratory parameters and quality of life, in ALS patients 2019-04-21 anticipated 22 Complete https://irct.ir/trial/48913 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method: Blocked Randomization Unit: Individual Randomization Tool: Number Table Using 2 therapeutic blocks (11 patients in each block ), patients were randomly placed in two separate blocks based on the patient's code and file number. Patients in these blocks were randomly transferred and a balanced randomized list of the two treatment groups was obtained. In the first group of patients, in addition to standard treatments, controlled exercise included diaphragmatic strengthening exercises and chest opening exercises. In the second group of patients, in addition to the treatments applied for the control group (the first group), they were also treated with an inspiratory muscle training device. N/A Amyotrophic lateral sclerosis. Intervention 1: Control group: In addition to standard treatments, patients undergo controlled exercise therapy, including diaphragmatic exercises and chest opening exercises. The duration of these exercises is 30 minutes. These exercises are performed for 8 weeks and twice a day. Intervention 2: Intervention group: In addition to standardized treatments and controlled exercise therapy (similar to the control group), patients use inspiratory muscle training device in a controlled manner. These exercises are repeated for 8 weeks and twice a day. Yes - There is a plan to make this available What will be shared: Clinical trial data will be published as an article When: Start access 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: Related scientific research Where to obtain: Masih Daneshvari Hospital, Chronic Respiratory Diseases Research Center, Tehran How to obtain: Provide the initial file of the approved research plan Comments:
public Maryam Mirenayat
Masih daneshvari Hospital, Shahid Bahonar St., Darabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 MirenayaT_M@yahoo.com Shahid Beheshti University of Medical Sciences scientific Atefeh Fakharian
Masih daneshvari Hospital, Shahid Bahonar St., Darabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 fakharian_2005@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Male and female patients with amyotrophic lateral sclerosis were diagnosed by a physician Ability to do exercises Maximal inspiratory pressure less than 60 cmH2O No history of surgery in the last 12 months No severe osteoporosis Shortness of breath less than 6 (Borg scale less than 6) no limit no limit Both Physical or mental disability of the patient to perform exercises Perform an intervention procedure or use non-invasive ventilation Patient dissatisfaction G12.21 Amyotrophic lateral sclerosis Rehabilitation Rehabilitation Control group: In addition to standard treatments, patients undergo controlled exercise therapy, including diaphragmatic exercises and chest opening exercises. The duration of these exercises is 30 minutes. These exercises are performed for 8 weeks and twice a day Intervention group: In addition to standardized treatments and controlled exercise therapy (similar to the control group), patients use inspiratory muscle training device in a controlled manner. These exercises are repeated for 8 weeks and twice a day. Quality of Life. Timepoint: Before the study and 8 weeks after the start of treatment. Method of measurement: Quality of Life Questionnaire. Maximum inspiratory pressure. Timepoint: Before the start of the study and 8 weeks after the treatment. Method of measurement: Spirometry. Maximum expiratory pressure. Timepoint: Before the start of the study and 8 weeks after the treatment. Method of measurement: Spirometry. Shahid Beheshti University of Medical Sciences Approved 2018-12-04 Ethics Committee of Shahid Beheshti University Shahid Arabi St., Yemen St.,Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)