[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581300":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":48,"locations":55,"responsibleParty":76,"collaborators":53,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":53,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":53,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":53,"overallStatus":58,"whyStopped":53,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Patras","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group","EXPERIMENTAL","In the BSATP Group, participants will use synchronous telerehabilitation methods such as communications platforms (e.g. Zoom etc.) and asynchronous methods like educational videos (created by the researchers to meet the needs of this study). Through these, they will follow a PFM exercise treatment program at a convenient location of their choice such as their home. No face-to face meetings will take place between participants and the therapist while supervision (regarding the execution, frequency of the PFM exercises etc.) will occur remotely.",[13],"Other: BSATP Group",{"label":15,"type":16,"description":17,"interventionNames":18},"FtFS (Face-to face Sessions) Group","ACTIVE_COMPARATOR","Participants will undertake their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist, drawing on the\"realistic\" treatment of UI, presently used in rehabilitation clinics etc.",[19],"Other: FtFS Group",{"label":21,"type":6,"description":22,"interventionNames":23},"CG (Control Group)","In the CG, participants will follow their PFM exercise treatment program without any supervision or face-to-face sessions with their therapist.",[24],"Other: Control Group (CG)",[26,32,38],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BSATP Group","Participants and the therapist will communicate once weekly synchronously (e.g. through video calls with a 30 minute duration), regarding the proper execution of the PFM exercises, providing motivation etc. Additionally, participants will be advised to watch the educational videos (10 mins duration) asynchronously twice a week. In total, participants will follow a BSATP three times a week (for 12 weeks). The PFM exercise program will include endurance training (slow velocity contractions), speed training (quick contractions) and \"Knack maneuver\" training (pre-contraction before the increment of the intra-abdominal pressure).The PFM exercise program will be based on three assessments conducted by the therapist throughout the study (baseline, 6 weeks and 12 weeks). As a result, the PFM exercise program will be individualized to meet their needs and progressively increases in difficulty, with the exercise position being modified every two weeks (e.g. supine, side, prone ect)",[9],[31],"Blended Synchronous and Asynchronous Telerehabilitation Programs",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"FtFS Group","Participants will attend one weekly face-to-face session with their therapist, to discuss the progress of their treatment and ensure its seamless continuation (intra-vaginal assessment, adjustments, motivation etc.). Each session will last approximately 30 minutes. Participants will also be advised to perform the PFM program twice a week on their own e.g. at home. In total, participants will follow a PFM program three times a week (for 12 weeks), once with their therapist and twice independently. The participants in the FtFS group will follow the same PFM exercise treatment program as the BSATP group, which will be an individualized program where the position will change every two weeks and include endurance training, speed training and 'Knack maneuver' training.",[15],[37],"Face-to face Sessions",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Control Group (CG)","The participants will be advised to follow a PFM exercise treatment program at home, based on an educational home leaflet (with instructions and images about PFM exercises) that they received during their first assessment session (baseline). The participants of this group will follow a PFM exercise therapy program (through the leaflet) which will last 12 weeks and they will be advised to attend it three times a week. No face-to-face meetings or supervision will occur by the therapist during the treatment period. Similarly to the other two intervention groups, the provided PFM exercise treatment program will be individualized, will include endurance training, speed training, and 'Knack maneuver' training, and the participants will be encouraged to change their exercise position on their own every two weeks.",[21],[43],"PFM exercises without supervision",[45],{"name":46,"affiliation":5,"role":47},"Dimitra-Tania Papanikolaou","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Evdokia Billis, Professor","CONTACT","6973047170",null,"billis@upatras.gr",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"University of Patras, School of Health Rehabilitation Science, Department of Physiotherapy","RECRUITING","Pátrai","Rion, Achaia","GR26504","Greece","GR",{"type":65,"coordinates":66},"Point",[67,68],21.73508,38.2462,{"lat":68,"lon":67},[71,74],{"name":50,"role":51,"phone":72,"phoneExt":73,"email":54},"+302610962406","+30",{"name":75,"role":51,"phone":53,"phoneExt":53,"email":53},"Professor",{"type":47,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Papanikolaou Dimitra-Tania","PhD(c)","100581300","synchronous-and-asynchronous-telerehabilitation-for-women-with-urinary-incontinence-100581300",false,"NCT06848517","Synchronous and Asynchronous Telerehabilitation for Women With Urinary Incontinence","The Effectiveness of a Blended Synchronous and Asynchronous Telerehabilitation Program for Greek Adult Women With Urinary Incontinence. A Randomized Controlled Trial","Inclusion Criteria:\n\n* Greek women,\n* 18-75 years old,\n* Diagnosis of Stress Urinary Incontinence (SUI) or Mixed UI (via Urodynamic examination).\n* Writing and reading of the Greek language\n* Having ease in using synchronous communication platforms (e.g., Zoom) and asynchronous educational videos via smart phones, tablets, computers etc\n* Able to voluntarily contract the PFM, during the initial clinical examination.\n\nExclusion Criteria:\n\n* 6 months after postpartum,\n* Systemic diseases\n* Malignancy,\n* Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,\n* Neurological dysfunction,\n* Mental impairment","FEMALE","18 Years","75 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"NA","In the adult female Greek population,approximately 27% suffer from urinary incontinence (UI). Nowadays, the conservative, evidence-based and 'gold standard' therapy of UI involves pelvic floor muscles (PFM) training programs, which are effective when performed intensively (daily) and for at least three months' duration. Unfortunately, patients' adherence to PFM exercises programs is often compromised for various reasons (lack of patient interest, inability to exercise daily etc.). Therefore, the development of synchronous and asynchronous telerehabilitation programs has revolutionized UI treatment, because they offer an interactive environment which might increase patient motivation and improve patient's adherence to this demanding PFM exercise regime. Synchronous Telerehabilitation Programs (STP) have developed via communication platforms that allow users to connect with video, audio, phone, and chat applications (e.g. Zoom), where users can interact in real time with their therapist and follow their treatment through the PFM exercise program. Furthermore, Asynchronous Telerehabilitation Programs (ATP) have emerged via mobile applications, educational videos etc., where users can follow their treatment using the PFM exercise program at a more convenient time that fits into their personal schedule. Although some studies have examined either STP or ATP with or without face-to-face sessions, no study has investigated a blended approach of STP and ATP for the management of UI.\n\nGiven the above, the primary aim of this study is to evaluate the effectiveness of a blended STP and ATP, in comparison to face-to-face therapy sessions. A secondary objective is to investigate the level of patients' adherence, and the amount of supervision required, in a blended STP and ATP. Furthermore, the necessity of telerehabilitation programs (whether provided in a synchronous or asynchronous manner) in the field of pelvic floor dysfunctions specifically in UI, will be explored. Finally, the study will assess the usability of a telerehabilitation program (whether provided in a synchronous or asynchronous manner) in women with UI.",[97],"Urinary Incontinence,Stress","2025-02-21",{"date":100,"type":101},"2025-02-27","ACTUAL",{"date":103,"type":101},"2025-02-15",{"date":105,"type":91},"2026-05-30",{"name":5,"class":6},1]