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IRCT20220129053870N1 IRCT 2022-02-08 Kharazmi University The Influence of Breathing Training and Exercise on Lumbopelvic Pain,Blood factors, gait, and function during Pregnancy (Selective Functional Movement Assessment(SFMA) The Influence of adding Breathing Training to Land based Whole body strength training &Aquanatal Exercises on Lumbopelvic Pain, Functional Disability, SFMA Scores, Physiological and gait parameters, and posture during Pregnancy 2022-03-06 anticipated 60 Complete https://irct.ir/trial/61633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following the baseline assessments, referring to http://www.randomization.com website, participants who meet the inclusion criteria will be randomly assigned into the Land-based whole body strength training & aqua natal exercises groups.Simple randomization will be used.Allocation concealment,the stage of performing the randomization process, the process of performing random allocation in the study, the person who create the random sequence, the person who consider participants in terms of inclusion and exclusion criteria, and the participants assignment‌‌ will be specified.Randomization will be performed from a computer-generated sequence, concealed in sequentially numbered, sealed, opaque envelopes, and will be kept by the hospital and motherland clinic . (1 for the land - based whole body strength training & 2 for the aqua natal training group) created before initiation of data collection by a researcher who is not involved in the recruitment or treatment of the patients.Then, the random numerical sequence is placed in the sealed opaque envelops. Another researcher blind to the baseline assessments will open an envelope and will process with treatment according to the group assignment. An independent assessor who is not aware of the study hypothesis and method, will assess the outcome measures before and after 14 weeks interventions, while is blind to the intervention groups, Blinding description: In this study the outcome assessors, data analyzer, and participants will be blinded to the process of randomization and devision of the individuals into two experimental and control groups. In the double-blind study, neither party involved in the trial know which group is receiving the actual treatment. Neither the participant nor the assessor, knows who is receiving what treatment. This method is used to prevent orientation in the results. The research set up double-blind with the main experimenter having a colleague. The main assessor is in the process of testing and launching, but their colleague is not in the process of testing. Since participants do not know which group they belong to, their beliefs about treatment do not affect the outcome. The researchers also do not know which groups are actually receiving treatment, they are unable to influence the treatment process by revealing small clues. A Double- blind study helps to reduce the effects of orientation on research. This orientation can include the unwanted influence of the researcher on the way of collecting information or dividing individuals into groups. Researchers sometimes inadvertently interfere in the research process because of their feelings about the research plan or their personal interest in obtaining a specific result. N/A Condition 1: Pregnancy related lumbo pelvic pain. Condition 2: Functional disability. Intervention 1: Intervention group: Whole Body Strength Training; The exercises include whole body exercises focusing on the myo fascial structures.This can spread the force throughout the body system, while minimizing excessive stress on the joints, allowing the joints to move in all three planes, improving overall body awareness and coordination.The selection of exercises according to previous studies will be done in the same direction. These exercises involve several fascia structures simultaneously. There are various techniques for designing exercises, including TRX exercises, lunges, dumbbell exercises, and squats. The exercises are performed in four fascial lines, including super fascial anterior, super fascial posterior, lateral, and spiral. Exercises are designed three times a week for 60 minutes (5 to 10 minutes of warm-up, 40 to 45 minutes of exercise routine, and finally 5 to 10 minutes of cool -down), with light to moderate intensity individualized for each subject. The exercises include 3 sets, depending on the ability of the individuals 5 to 10 repetitions, in each set with a break of 20 to 40 seconds between each set. In order to exercise progression principle, if a person is able to perform movements, the exercises will be upgraded to an advanced level. Intervention 2: Intervention group: Aqua natal exercises; Exercise in the water specifically in this study will be done during 20 to 34 weeks of pregnancy. These exercises are designed for three sessions per week for 14 weeks, each session will last 60 minutes, which will be divided into two parts: 1. Strengthening 2. Balance and aerobics. In the first (strengthening) phase of this exercise routine, which will be performed during the 20-24 weeks of pregnancy, the sessions consist of three stages: warm-up, the main phase, and finally stretching and relaxation. In the second phase of training (balance exercises and aerobics), which will be performed during the 24-34 weeks of pregnancy, the exercises will be organized and performed in pregnant women. The intensity of the exercises will be based on the Borg scale and the target heart rate. Maximum oxygen consumption will be assessed using the Bruce Modified Exercise Test. The reserve heart rate will be calculated from the Karvonen formula (Target heart rate = percentage of exercise intensity multiplied by Maximum heart rate-resting heart rate + resting heart rate) and different intensities of aerobic exercise will also be adjusted. 30 degrees Celsius (86 degrees Fahrenheit) will be set and pregnant women will be immersed in water up to the xiphoid process (pool depth will vary depending on the individuals height). Intervention 3: Intervention group: Breathing Training added to two interventions in each group;Breathing exercises using a balloon: Breathing exercises are performed in a sitting position with the thigh and knee 90 degrees. In this case, the patient is asked to hold the balloon with one hand and breathe through the nose with the tongue on the roof of the mouth (normal resting position) and then exhale through the mouth into the balloon. 75% of the maximum is usually 3-4 seconds, and a full exhalation usually takes 5-8 seconds and then pauses for 2-3 seconds. This slow breathing is thought to further relax the parasympathetic nervous system / nervous system and generally reduce the tone of resting muscles. Ideally, the patient can breathe again without pressing the balloon with their teeth and lips. This requires maintaining intra-abdominal pressure to allow inhalation through the nose without returning air from the balloon and into the mouth. Yes - There is a plan to make this available What will be shared: Demographic and outcomes-related data are the files which will be shared. When: After publishing paper(s) extracted from the study. To whom: The data can be displayed and shared at the reasonable request of the Iranian Clinical Trail Registration center, journals, and University individuals/ researchers who are conducting research and scientific activities related to this field. Conditions: Data analysis and the use of documentation can only be provided which their results are reported in systematic review articles by academic researchers and authors. Requirements for sharing data and documents include: 1. To Send an email ( preferably with a valid university address) to one of the study researchers/ authors 2. A brief and logical explanation of how to use the data or documentations. 3.Ensuring That the protocol the protocol for systematic review studies, any accessing request to data or documentations will be recorded. Where to obtain: Through asking from authors; Amir Letafatkar, letafatkaramir@yahoo.com NiloufarFarivar, Niloufar_farivar@yahoo.com How to obtain: The applicant can request details from the researchers within 7-10 days by an official message sent via an email. Comments:
public Amir Letafatkar
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport complex
Tehran Iran (Islamic Republic of) ۴۳۹۸-۱۵۸۷۵ +98 21 2222 8001 letafatkaramir@yahoo.com Kharazmi University scientific Amir Letafatkar
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport complex
Tehran Iran (Islamic Republic of) ۴۳۹۸-۱۵۸۷۵ +98 21 2222 8001 letafatkaramir@yahoo.com Kharazmi Universityb Iran (Islamic Republic of) Healthy pregnant women in 18 -22 week of pregnancy Age 20-35 years old Nolyparus No history of abortion Normal first & the second pregnancy screening results Received at least the first shot of covid-19 vaccine Being diagnosed with lumbopelvic pain by a gynecologist 20 years 35 years Female Any spinal phatology Neoplastic process Infections Vascular diseases Endocrine & metabolic diseases Being under treatment & giving pain killers for lumbopelvic pain A history of lumbar spine surgery Uterus & vaginal bleeding Any contraindication of exercise in pregnancy regarding the Royal College of Obstetrician & Gynecologists guidelines R10.2 O26.89 Pelvic and perineal pain Other specified pregnancy related conditions Rehabilitation Rehabilitation Rehabilitation Intervention group: Whole Body Strength Training; The exercises include whole body exercises focusing on the myo fascial structures.This can spread the force throughout the body system, while minimizing excessive stress on the joints, allowing the joints to move in all three planes, improving overall body awareness and coordination.The selection of exercises according to previous studies will be done in the same direction. These exercises involve several fascia structures simultaneously. There are various techniques for designing exercises, including TRX exercises, lunges, dumbbell exercises, and squats. The exercises are performed in four fascial lines, including super fascial anterior, super fascial posterior, lateral, and spiral. Exercises are designed three times a week for 60 minutes (5 to 10 minutes of warm-up, 40 to 45 minutes of exercise routine, and finally 5 to 10 minutes of cool -down), with light to moderate intensity individualized for each subject. The exercises include 3 sets, depending on the ability of the individuals 5 to 10 repetitions, in each set with a break of 20 to 40 seconds between each set. In order to exercise progression principle, if a person is able to perform movements, the exercises will be upgraded to an advanced level. Intervention group: Aqua natal exercises; Exercise in the water specifically in this study will be done during 20 to 34 weeks of pregnancy. These exercises are designed for three sessions per week for 14 weeks, each session will last 60 minutes, which will be divided into two parts: 1. Strengthening 2. Balance and aerobics. In the first (strengthening) phase of this exercise routine, which will be performed during the 20-24 weeks of pregnancy, the sessions consist of three stages: warm-up, the main phase, and finally stretching and relaxation. In the second phase of training (balance exercises and aerobics), which will be performed during the 24-34 weeks of pregnancy, the exercises will be organized and performed in pregnant women. The intensity of the exercises will be based on the Borg scale and the target heart rate. Maximum oxygen consumption will be assessed using the Bruce Modified Exercise Test. The reserve heart rate will be calculated from the Karvonen formula (Target heart rate = percentage of exercise intensity multiplied by Maximum heart rate-resting heart rate + resting heart rate) and different intensities of aerobic exercise will also be adjusted. 30 degrees Celsius (86 degrees Fahrenheit) will be set and pregnant women will be immersed in water up to the xiphoid process (pool depth will vary depending on the individuals height). Intervention group: Breathing Training added to two interventions in each group;Breathing exercises using a balloon: Breathing exercises are performed in a sitting position with the thigh and knee 90 degrees. In this case, the patient is asked to hold the balloon with one hand and breathe through the nose with the tongue on the roof of the mouth (normal resting position) and then exhale through the mouth into the balloon. 75% of the maximum is usually 3-4 seconds, and a full exhalation usually takes 5-8 seconds and then pauses for 2-3 seconds. This slow breathing is thought to further relax the parasympathetic nervous system / nervous system and generally reduce the tone of resting muscles. Ideally, the patient can breathe again without pressing the balloon with their teeth and lips. This requires maintaining intra-abdominal pressure to allow inhalation through the nose without returning air from the balloon and into the mouth. Pain; Lumbo pelvic pain. Timepoint: At the baseline ( before interventions ), weeks 34 & 38 of pregnancy(after interventions & follow up). Method of measurement: Visual Analogue Scale(VAS). Functional Disability. Timepoint: At the baseline ( before interventions ), weeks 34 & 38 of pregnancy(after interventions & follow up). Method of measurement: Oswestry Disability Questionnaire. Physiologic Parameters. Timepoint: At the baseline ( before interventions), weeks 34& 38 of pregnancy ( After interventions & follow up ). Method of measurement: Blood Lab Exams. Gait parameters. Timepoint: At the baseline ( before interventions), weeks 34 & 38 of pregnancy ( After interventions & follow up ). Method of measurement: Kinovea Soft ware. Posture. Timepoint: At the baseline ( before interventions), weeks 34& 38 of pregnancy ( After interventions & follow up ). Method of measurement: Kinovea Soft ware. Selective Functional Movement Assessment(SFMA). Timepoint: At the baseline ( before interventions), weeks 34& 38 of pregnancy ( After interventions & follow up ). Method of measurement: Regarding to the Selective Functional Movement Assessments (SFMA) scores presented by Gray Cook. Kharazmi University This study has bern conducted by the researchers and no organizational fund has been received. This study has bern conducted by the researchers and no organizational fund has been received. Approved 2022-01-19 Sports sciences research institute No.3, Fifth Alley, Mir Emaad St, Ostad Motahari Street, Tehran Tehran Tehran Iran (Islamic Republic of)