[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640906":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":52,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Taipei Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Participants in the experimental group will receive a 6 week combined BFR and IMT intervention",[13],"Behavioral: Exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.",[19],"Behavioral: Sham Control",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Exercise","Each session will last approximately 60 minutes and will include three components: (1) an initial 3-minute IMT exercise performed at an intensity corresponding to rating of perceived exertion (RPE) 11-13 on the Borg 6-20 scale, (2) a 50-minute low-intensity exercise program combined with BFR, and (3) a second 3-minute IMT session at the same target intensity.\n\nFor the IMT, the protocol follows a progressive intensity model, starting with 30% of the maximum inspiratory pressure (MIP) in Week 1 to allow participants to become familiar with the technique. The intensity will gradually increase to a target of 60% MIP by Week 6, based on the participants' tolerance.\n\nFor the BFR, during weeks 1-2, participants will train at constant loads. From weeks 2-6, training loads will be increased. Cuff pressure will be prescribed relative to the calculated arterial occlusion pressure (AOP): 50% in weeks 1-2, 60% in weeks 3-4, and 70% in weeks 5-6 for both lower- and upper-body exercises.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Control","Participants in the control group will perform the identical BFR exercise protocol as the intervention group. However, IMT will be delivered at 2% of MIP, which is considered a sham condition and has not been shown to improve respiratory muscle function",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Pei-Shan Tsai Professor, PhD","CONTACT","+886227361661","6321","ptsai@tmu.edu.tw",[39],{"facility":5,"status":26,"city":40,"state":26,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Taipei","11031","Taiwan","TW",{"type":45,"coordinates":46},"Point",[47,48],121.52639,25.05306,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Pei-Shan, Tsai","Professor",[57,59],{"name":58,"class":6},"National Taiwan University",{"name":60,"class":61},"The University of Texas at Austin","UNKNOWN","100640906","feasibility-and-effects-of-inspiratory-muscle-training-combined-with-blood-flow-restriction-for-frail-older-adults-100640906",false,"NCT07573995","Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults","Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Community-dwelling adults aged 65 years and older who are classified as at least \"vulnerable\" using the Clinical Frailty Scale (score ≥4).\n* Participants must have no cognitive impairment and be able to follow commands, as assessed by the Mini-Mental State Examination (MMSE).\n\nExclusion Criteria:\n\n* (1) are unable to participate in exercise (e.g., due to severe musculoskeletal disorders)\n* (2) have high-risk factors for exercise, such as uncontrolled hypertension (\\>150 mmHg systolic blood pressure (SBP) \u002F \\>90 mmHg diastolic blood pressure (DBP), coagulation disorders, and deep venous thrombosis\n* (3) have hematological disorders or are using hematology related-medications\n* (4) have significant comorbidities, including a history of stroke, diabetes with severe complications, or cardiovascular diseases\n* (5) chronic lung conditions (e.g., obstructive pulmonary disease, asthma), and\n* (6) have participated in a structured exercise training program within the past 3 months at a frequency exceeding three sessions per week.","ALL","65 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"NA","This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.",[79,80,81,82],"Frailty Syndrome","Older Adults","Blood Flow Restriction (BFR) Training Effects","Inspiratory Muscle Training",[84,85,86,87],"frailty","older adults","blood flow restriction","inspiratory muscle training","NOT_YET_RECRUITING","2026-05-01",{"date":91,"type":92},"2026-05-07","ACTUAL",{"date":94,"type":73},"2026-05",{"date":96,"type":73},"2026-10",{"name":5,"class":6},1]