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IRCT20200827048542N1 IRCT 2020-10-25 Tehran University of Medical Sciences Effect of Respiratory Muscle Training in Multiple Sclerosis MS Evaluation the Effect of 8 Weeks Respiratory Muscle Training on Respiratory Capacity, Functional Capacity and Quality of Life on Subjects with Mild to Moderate Relapsing Remitting Multiple Sclerosis 2020-10-22 anticipated 36 Complete https://irct.ir/trial/51280 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are allocated to two groups by computer-generated randomization in blocks of 36 in a 1:1 ratio. The patients are randomized to 1 of 2 groups: the intervention group (RMT) and the control group. A research assistant not involved in any other part of the study will open the sealed opaque envelopes and assign the patients to their respective treatment groups, Blinding description: The assessor is a sports medicine specialist who is blinded to dividing the groups of patients. Moreover, the results will also be analyzed by a statistical researcher, that is blinded to dividing the groups of patients. Teaching respiratory muscle exercises to the intervention group as well as explaining the general exercise training booklet in both groups is done by a sports medicine specialist who is not involved in patient evaluation. N/A Multiple Sclerosis. Intervention 1: Intervention group:،They will educated respiratory muscle training with a pressure threshold device (Power-breath), then patients will do exercises for 8 weeks. During this time, patients will be followed up by telephone and the intensity of the device will be increased on a weekly basis. Intervention 2: Control group: ،They will be explained about the training and importance of regular physical activity in MS patients and lifestyle modification, and will be given a booklet on the subject. During the program, patients receive their usual medication as before. Yes - There is a plan to make this available What will be shared: Specific participant data sets are to be shared (e.g., all collected deidentified IPD, IPD collected for the primary outcome measure only, etc). When: starting immediately after publication To whom: information/documents are available for people working in academic institutions and also people working in businesses. Conditions: For use in meta-analysis studies or systematic review articles Where to obtain: Shima Ghannadi. Sports Medicine Research Center. No 7, Al-e-Ahmad Highway, Tehran, IR Iran. Email Address: Sh_ghannadi90@yahoo.com How to obtain: After reviewing the email, the documents or files will be emailed to the applicant within a week. Comments:
public Shima Ghannadi
No 7, Al-e-Ahmad Highway, Tehran, IR Iran
Tehran Iran (Islamic Republic of) 14395-578 +98 21 8863 0227 Sh_ghannadi90@yahoo.com Tehran University of Medical Sciences scientific Shima Ghannadi
No 7, Al-e-Ahmad Highway, Tehran, IR Iran
Tehran Iran (Islamic Republic of) 14395-578 +98 21 8863 0227 Sh_ghannadi90@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Definite diagnosed relapsing-remitting MS Year after diagnosed at least one year Be able to walk without support at least 10 meters Not have an relapse at least one month Taking no intravenous corticosteroid drug 18 years no limit Both history of any respiratory disease have an active pulmonary infection Contraindicated for aerobic activity (such as orthopedic and muscular problem) smoker pregnancy Participate in another research program G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group:،They will educated respiratory muscle training with a pressure threshold device (Power-breath), then patients will do exercises for 8 weeks. During this time, patients will be followed up by telephone and the intensity of the device will be increased on a weekly basis. Control group: ،They will be explained about the training and importance of regular physical activity in MS patients and lifestyle modification, and will be given a booklet on the subject. During the program, patients receive their usual medication as before. Maximum Inspiratory Pressure. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Body Box machine. Maximum Expiratory Pressure. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Body Box machine. Quality of Life. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: SF-36 questionnaire. Aerobic capacity. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Six Minute Walk Test (6MWT). Functional capacity. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Timed Up and Go test (TUG). Forced Expiratory volume in the first second (FEV1). Timepoint: before intervention and 8 weeks after interventio. Method of measurement: Spirometry. Forced Expiratory volume in the first second (FEV1)/Forced Vital Capacity (FVC). Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Spirometry. Fatigue. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Modified Fatigue Impact Scale questionnaire (MFIS). Tehran University of Medical Sciences Approved 2018-06-23 Ethics committee of Tehran University of Medical Sciences No 7, Al-e-Ahmad Highway, Tehran, IR Iran Tehran Tehran Iran (Islamic Republic of)