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IRCT20210702051761N1 IRCT 2021-07-23 Sahand University of Technology Extraction of Muscle Synergies after Pelvic Floor Muscle Training in Women with Urinary Incontinence Extraction of Muscle Synergies to Investigate Changes in Biomechanical Parameters after the Addition of Abdominal Hypopressive Technique to Pelvic Floor Muscle Training in Women with Urinary Incontinence 2021-07-23 anticipated 78 Complete https://irct.ir/trial/57367 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random numbers will be generated between 1 and 52 by using a computer algorithm (matlab code: randi) to specify two intervention groups (1 and 2, each group owns 26 participants). The numbers will be kept in concealed envelopes. Patients, researchers, and analyzers will not be aware of what intervention has been applied to the participants, Blinding description: The patient is explained that there are two types of intervention, but the person is not informed of her assigned group. The patient is initially evaluated by a researcher (blind) before assigning the group. At the end of the initial evaluation, the patient chooses a concealed envelope and delivers it to the research assistant. In this way, the patient identifies the group itself but is not aware of the results of randomization. The clinical assistant teach the home exercises and explains the training sessions based on the intervention group that she is in. At the end of the intervention, the researcher performs the final evaluation of the patient without knowing the treatment the patient has received. The analyzer which is blind to the intervention group using coded results performs the output analyses. The healthy control group does not need to be blind, as they are not patient and do not receive any intervention, and, only have an initial evaluation. The blindness of the participants means blindness of the patients who all receive interventions. N/A Stress Urinary Incontinence. Intervention 1: Intervention group: Pelvic floor muscle training will be performed for 12 weeks, once a week supervised by a physiotherapist and every day of the week at home. The exercises consist of 10 progressive stages that will progress one stage per week. It takes two weeks for people to reach the level expected by the researcher. The exercises include stretching exercises (15-30 seconds each) and strengthening exercises (10-12 seconds). The rest time between each contraction is 10-12 seconds. During the treatment process, continuous and slow breathing is performed. Pelvic floor contraction is similar to a condition in which a person is asked to stop urinating while urinating. Each exercise is repeated three sets a day and each set 10 times. Intervention 2: Intervention group: Pelvic floor muscle training + abdominal hypopressive technique (AHT) that in addition to receiving the full protocol of the first group, will also receive AHT exercises with Caufriez technique for 12 weeks. At the familiarization session, participants will be provided with information on the location and function of the PFM and TrA muscle. They are taught how to contract their PFM and TrA exclusively. Then, how to do AHT is taught; By first performing a slow diaphragmatic inhalation, followed by a general exhalation with closed glottal pathway, which is accompanied by a gradual contraction of the abdominal wall muscles with diaphragmatic aspiration. The person is also taught how to contract their PFM in different positions at the same time as the diaphragm aspiration. The number of sessions and their durations are the same as the previous intervention group. Intervention 3: Healthy control group: without any intervention, only participated for initial assessments. Yes - There is a plan to make this available What will be shared: All processed and analyzed data will be released. These data include the questionnaire scores and linear and nonlinear outcomes of the stability, before and after the interventions. When: from 6 months after the official publication of results To whom: All academic and clinical researchers Conditions: Only for therapeutical applications and use in neuro-musculoskeletal simulations Where to obtain: By contacting the corresponding author of the published papers by email, phone or postal address How to obtain: Process: 1. Determining the data of interest by the applicant 2. contacting the corresponding author to submit the queries by the applicant 3. Reviewing the queries by the research team 4. Responding to the queries till 10 working days by the research team Comments:
public Masumeh Babayi
University Road, Sahand New Town
Tabriz Iran (Islamic Republic of) 5331811111 +98 21 8801 2534 m_babayi@sut.ac.ir Sahand University of Technology scientific Mahmoodreza Azghani
University Road, Sahand New Town
Tabriz Iran (Islamic Republic of) 5331811111 +98 41 3345 8417 azghani@sut.ac.ir Sahand University of Technology Iran (Islamic Republic of) Stress Urinary Incontinence (SUI) with at least 3 leaks per week ICIQ-UI SF Score >= 5 Married 25 years 50 years Female Pregnancy Menopause History of cancer History of pelvic surgery POP > 2 OGS < 3 Having Over Active Bladder (OAB) PVR > 50 ml History of hormone therapy Urinary tract infection Low Back pain in the last 3 months Any known disease of the nervous system N39.3 Stress incontinence (female) (male) Rehabilitation Rehabilitation N/A Intervention group: Pelvic floor muscle training will be performed for 12 weeks, once a week supervised by a physiotherapist and every day of the week at home. The exercises consist of 10 progressive stages that will progress one stage per week. It takes two weeks for people to reach the level expected by the researcher. The exercises include stretching exercises (15-30 seconds each) and strengthening exercises (10-12 seconds). The rest time between each contraction is 10-12 seconds. During the treatment process, continuous and slow breathing is performed. Pelvic floor contraction is similar to a condition in which a person is asked to stop urinating while urinating. Each exercise is repeated three sets a day and each set 10 times. Intervention group: Pelvic floor muscle training + abdominal hypopressive technique (AHT) that in addition to receiving the full protocol of the first group, will also receive AHT exercises with Caufriez technique for 12 weeks. At the familiarization session, participants will be provided with information on the location and function of the PFM and TrA muscle. They are taught how to contract their PFM and TrA exclusively. Then, how to do AHT is taught; By first performing a slow diaphragmatic inhalation, followed by a general exhalation with closed glottal pathway, which is accompanied by a gradual contraction of the abdominal wall muscles with diaphragmatic aspiration. The person is also taught how to contract their PFM in different positions at the same time as the diaphragm aspiration. The number of sessions and their durations are the same as the previous intervention group. Healthy control group: without any intervention, only participated for initial assessments Electromyography of the pelvic floor and abdominal muscles. Timepoint: Before and after the interventions. Method of measurement: Electromyogram. Intra-abdominal and vaginal pressures. Timepoint: Before and after the interventions. Method of measurement: Pressure sensor probe. Scores of ICIQ-UI SF, ICIQ-LUTS QOL and BROOME questionnaires. Timepoint: Before and after the interventions. Method of measurement: ICIQ-UI SF, ICIQ-LUTS QOL and BROOME questionnaires. Sahand University of Technology Approved 2021-07-05 Research Ethics Committees of Tabriz University of Medical Sciences Central Building of Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)