[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617580":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":35,"locations":25,"responsibleParty":45,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":25},{"fullName":5,"class":6},"Imam Abdulrahman Bin Faisal University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group : IMT with 40%Of MIP +walking +resisancee training","EXPERIMENTAL","Experimental Group: Twenty-four participants will practice aerobic exercise (30 minutes of walking at 40-60% of HRmax) and resistance training in addition to IMT (starting resistance level of 40%) three times a week for six weeks.\n\nHome program: All participants of both groups will also perform different exercises, including aerobic, resistive, and IMT training two times per week at home. The participants from both groups will receive detailed instructions to guide them in performing home sessions. Follow up with them through WhatsApp and Zoom, and call them every other day to check their performance and encourage them. Participants will also have logbooks for documentation and to count the adherence and compliance.",[13],"Device: Inspiratory muscle trainer",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group: IMT with 0% of MIP +walking +resistance training","PLACEBO_COMPARATOR","Twenty-four participants will practice aerobic exercise (30 minutes of walking at 40-60% of HRmax) and resistance training in addition to IMT (starting resistance level of 0%) three times a week for six weeks.\n\nHome program: All participants of both groups will also perform different exercises, including aerobic, resistive, and IMT training two times per week at home. The participants from both groups will receive detailed instructions to guide them in performing home sessions. Follow up with them through WhatsApp and Zoom, and call them every other day to check their performance and encourage them. Participants will also have logbooks for documentation and to count the adherence and compliance.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Inspiratory muscle trainer","Inspiratory muscle trainer: The POWER breath device has a variable resistance, which can be adjusted by a calibrated spring. The initial resistance training level will be adjusted at 0% resistance for the control group and 40% of MIP for the experimental group. The participants will be instructed to use the device twice daily (two times per day, in the hospital under supervision, 30 breaths in each session) for three days a week for 6 weeks, with periods of rest, especially if the patient feels dizzy or fatigued.",[15,9],null,[27,31],{"name":28,"affiliation":29,"role":30},"Maali M Alqahtani, Master","Imam Andulrahman BinFaisal University","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":34},"Alsayed M Shanab, PhD","Imam Abdulrahman BinFaisal University","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Maali M Alqahtani, master","CONTACT","0568899888","maalqahtani@iau.edu.sa",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Alsayed Shanab, PhD","0555786349","aashanb@iau.edu.sa",{"type":30,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Maali Mohammed Alqahtani","Lecturer","100617580","efficacy-of-inspiratory-muscle-trainers-on-patients-with-obesity-and-lowback-pain-100617580",false,"NCT07320469","Efficacy of Inspiratory Muscle Trainers on Patients With Obesity and LowBack Pain","Efficacy of Inspiratory Muscle Trainer on Respiratory Functions Exercise Capacity and Pain Intensity in Adults With Obesity and Mechanical Low Back Pain. A Randomized Clinical Trial.","Inclusion Criteria:\n\n* Males and females\n* Aged between 20 and 50 years\n* Obese and experiencing mechanical low back pain (MLBP)\n* A body mass index (BMI) between 30 and 40 kg\u002Fm²\n* low back pain for more than 12 weeks, with pain localized to the lumbar region - A pain score greater than 3 but less than 7 on the Numeric Pain Rating Scale (NPRS).\n* Low back pain will be screened using the Mechanical and Inflammatory Low Back Pain (MIL) Index.\n* Stable and controlled medical conditions\n\nExclusion Criteria:\n\n* Medically unstable\n* Severe spinal pathology, e.g., infection, tumor, arthritis, inflammation, spine deformity, advanced neurologic diseases, head or spinal surgeries, rheumatic diseases, and respiratory muscle paralysis\n* Acute inflammation of the musculoskeletal system\n* Pregnancy\n* Unable to follow instructions, e.g., those with learning difficulties",true,"ALL","20 Years","55 Years",{"count":60,"type":61},48,"ESTIMATED","INTERVENTIONAL",[64],"NA","Background: Obesity and mechanical low back pain (MLBP) are two major health problems negatively affecting the human body. Many studies have shown that obesity and MLBP are associated with negative effects on the respiratory system. There are many interventions to treat obesity and MLBP, such as aerobic exercise and diet programs. Moreover, the Inspiratory Muscle Trainer (IMT) significantly improved inspiratory muscle strength in patients with obesity. This study aims to investigate whether adding IMT to aerobic exercise will improve respiratory function, exercise capacity, and pain intensity in patients with obesity and MLBP. Materials and Methods: A total of forty-eight obese patients with MLBP will be equally and randomly assigned to the experimental group and control group. The experimental group will have training on IMT for 6 weeks, three days per week (two sessions daily, thirty breaths per session) using POWERbreathe IMT, starting at 40% of maximal inspiratory pressure with increasing training load at the third week, in addition to having aerobic exercise three times a week for 30 minutes and total body resistance. The control group will have the same training as the experimental group, except for IMT; they will have zero resistance. Main outcome measures: pulmonary function tests and maximal inspiratory pressures to assess respiratory function; VO2 to assess exercise capacity; pain intensity; and Oswestry Disability Index to determine functional disability. All the measurements will be done before and after the intervention in both groups. Paired and independent t-tests will be used to compare within- and between-group differences. A repeated-measures design will be used to determine significant differences before, during, and after the intervention within each group.",[67,68],"Obesity","Low Back Pain",[70,71,72,73,74,75,76,77,78],"obesity","low back pain","obesity and low back pain","inspiratory muscle trainers","respiratory function","exercise capacity","functional disability","pain intensity","body compisition","NOT_YET_RECRUITING","2025-12-27",{"date":82,"type":83},"2026-01-06","ACTUAL",{"date":85,"type":61},"2026-03-01",{"date":87,"type":61},"2026-08-30",{"name":5,"class":6}]