]>
IRCT20180916041051N3 IRCT 2024-05-23 Iran University of Medical Sciences Effectiveness of pelvic floor exercises and breathing exercises on urinary disorders of people with multiple sclerosis EDSS: Expand Disability Status Scale; ICIQSF: Incontinence Questionnaire Short Form; MMSE: Mini-Mental State Examination; MS: Multiple Sclerosis; PFM: pelvic floor muscle; RCT: Randomized controlled trial Investigating the effect of pelvic floor muscle training and breathing exercise on pelvic floor muscle activity, diaphragm activity, and urinary symptoms in patients with multiple sclerosis 2024-05-21 anticipated 50 Complete https://irct.ir/trial/76408 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization is done using the Randomization website. Both groups will be matched in terms of demographic characteristics. They will be randomly divided into two treatment groups with a ratio of 1:1. Random allocation is done by the variable block method, which includes 4-letter blocks, made of letters A and B. The obtained treatment allocation is placed in sealed and numbered envelopes in the form of letters A and B. This process is done by someone outside the research team before the start of the study. After the initial evaluations by the examiner, the numbered envelopes are presented to him according to the sequential number of each person entered into the study, and the therapeutic intervention is adjusted based on the letters inside the envelope. The examiner is unaware of the letters inside the envelope. N/A Multiple sclerosis. Intervention 1: Intervention group: Receiving breathing exercises and PFM exercises. Breathing exercises will be done using the Power Breathe classic device (POWERbreathe International Ltd, England). This device strengthens the respiratory muscles by creating appropriate pressure (10-15 mmHg). Participants will use this device while doing PFM exercises at the same time. Participants will do exercises 4 days a week for 8 weeks (24 sessions) under the supervision of a physiotherapist. Intervention 2: Control group: Receiving PFM exercises. Exercises will be done in supine, sitting, quadruped, standing, and walking. The participant is asked to contract the PFM and hold each contraction for 5-10 seconds. Exercises will be performed three times daily (morning, evening, and night) with 8-10 repetitions in each exercise set. Participants will do exercises 4 days a week for 8 weeks (24 sessions) under the supervision of a physiotherapist. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public شبنم شاه علی
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) ۱۵۴۵۹۱۳۴۸۷ +98 21 2222 8051 shabnamshahali@yahoo.com Iran University of Medical Sciences scientific هلاکو محسنی فر
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) ۱۵۶۸۶۴۸۵۱۱ +98 21 2222 8051 Mohsenifarpt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age 18to50 years Diagnosis of relapsing-remitting MS disease MMSE scale score greater than 24 EDSS scale score less than 3.5 Not suffering from cardiovascular diseases, kidney diseases, rheumatism, visceral diseases, other neurological diseases (other than MS), malignancies and infections No pregnancy or history of childbirth in the last 6 months Not having a history of surgery to treat urinary incontinence Absence of prolapse of pelvic organs with intensity higher than 2 Not having a score of 19-21 from the ICIQ-SF questionnaire Not having a history of MS relapse in the last 3 month Ability to understand and write concepts and information Not having chronic obstructive pulmonary disease, bronchitis and tuberculosis Absence of MS plaques in the medulla (due to the presence of respiratory control areas) Body mass index (BMI) below 30 18 years 50 years Both The patient's unwillingness to participate in the study Rehabilitation Rehabilitation Intervention group: Receiving breathing exercises and PFM exercises. Breathing exercises will be done using the Power Breathe classic device (POWERbreathe International Ltd, England). This device strengthens the respiratory muscles by creating appropriate pressure (10-15 mmHg). Participants will use this device while doing PFM exercises at the same time. Participants will do exercises 4 days a week for 8 weeks (24 sessions) under the supervision of a physiotherapist. Control group: Receiving PFM exercises. Exercises will be done in supine, sitting, quadruped, standing, and walking. The participant is asked to contract the PFM and hold each contraction for 5-10 seconds. Exercises will be performed three times daily (morning, evening, and night) with 8-10 repetitions in each exercise set. Participants will do exercises 4 days a week for 8 weeks (24 sessions) under the supervision of a physiotherapist. Severity of urinary incontinence. Timepoint: It is checked at the beginning of the study (before the intervention) and the last session. Method of measurement: ICIQSF questionnaire. PFM function. Timepoint: It is checked at the beginning of the study (before the intervention) and the last session. Method of measurement: It is measured by ultrasound imaging. Diaphragm muscle function. Timepoint: It is checked at the beginning of the study (before the intervention) and the last session. Method of measurement: It is measured by ultrasound imaging. Iran University of Medical Sciences Approved 2024-04-14 Ethics committee of Iran University of Medical sciences Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)