[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615153":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":81,"studyPopulation":74,"armGroups":82,"interventions":105,"overallOfficials":123,"centralContacts":128,"locations":136,"responsibleParty":153,"collaborators":74,"id":156,"slug":74,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":74,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":74,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":74,"overallStatus":139,"whyStopped":74,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"National Cheng Kung University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":74},[9,13],{"measure":10,"description":11,"timeFrame":12},"Diaphragm excursion and thickness","Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration","Change from baseline (0 week) to follow up (16 weeks)",{"measure":14,"description":15,"timeFrame":16},"Exercise capacity","A cardiopulmonary exercise test collects gases (including measures of oxygen consumption in ml\u002Fkg\u002Fmin), which can be used to estimate exercise capacity","Change form baseline (0 week) to follow up (16 weeks)",[18,21,24,27,31,34,37,40,43,46,49,52,55,58,62,65,68,71],{"measure":19,"description":20,"timeFrame":16},"Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)","Heart rate variability (HRV) is examined to assess the autonomic nervous system. Standard Deviation of Normal-to-Normal Intervals (SDNN, in ms)reflects overall heart rate variability and autonomic function",{"measure":22,"description":23,"timeFrame":16},"Heart rate variability (Root Mean Square of Successive Differences, RMSSD)","Root Mean Square of Successive Differences (RMSSD in ms) represents short-term HRV and parasympathetic activity",{"measure":25,"description":26,"timeFrame":16},"Heart rate variability (Low Frequency power, LF)","Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation.",{"measure":28,"description":29,"timeFrame":30},"Heart rate variability (High Frequency power, HF)","High frequency power (HF in ms²) reflects parasympathetic (vagal) activity.","Change from baseline (0 week) to follow-up (16 weeks)",{"measure":32,"description":33,"timeFrame":30},"Heart rate variability (LF\u002FHF Ratio)","LF\u002FHF ratio represents sympathovagal balance.",{"measure":35,"description":36,"timeFrame":12},"Pulmonary function test","Pulmonary function test is examined by spirometry, which measures the ability to inhale and exhale air over time. The results include forced vital capacity (FVC in L), forced exploratory volume in the first second (FEV1 in L), and the FVC\u002FFEV1 ratio.",{"measure":38,"description":39,"timeFrame":12},"Functional capacity","Functional capacity is examined by 6 minute walking test (6MWT, in m)",{"measure":41,"description":42,"timeFrame":12},"Functional ability","Functional ability is examined using the Timed Up and Go (TUG) test, where the time taken (in seconds) to complete the test is recorded.",{"measure":44,"description":45,"timeFrame":12},"Sit-and-Reach Test","Flexibility is examined by the sit and reach test (unit: cm).",{"measure":47,"description":48,"timeFrame":30},"Handgrip Strength","Maximal voluntary handgrip strength. (unit: N)",{"measure":50,"description":51,"timeFrame":12},"Upper Limb Muscle Strength","Maximal voluntary contraction of upper limb muscles. (unit: N)",{"measure":53,"description":54,"timeFrame":12},"Neck Muscle Strength","Maximal voluntary contraction of neck muscles. (unit: N)",{"measure":56,"description":57,"timeFrame":30},"Knee Extensor Strength","Maximal voluntary contraction of the knee extensor muscles. (unit: N)",{"measure":59,"description":60,"timeFrame":61},"Maximum respiratory pressure","Maximum respiratory pressure is measured using a manometer, which records both maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), in cmH₂O.","Change from baseline (0 week) to follow up (20 weeks)",{"measure":63,"description":64,"timeFrame":16},"Fatigue Severity Scale (FSS)","the Fatigue Severity Scale (FSS) is a 7-point scale questionnaire that measures the patient's level of fatigue. It contains 9 questions, and a total score of 36 points or higher indicates that the patient may be experiencing clinically significant fatigue and requires further evaluation.",{"measure":66,"description":67,"timeFrame":16},"Kidney Disease Quality of Life (KDQOL)","The Kidney Disease Quality of Life (KDQOL) questionnaire is a standard tool for patients with kidney disease. It contains several subscales, and the raw scores are converted into normalized scores, with higher scores indicating better quality of life.",{"measure":69,"description":70,"timeFrame":12},"Modified Medical Research Council (mMRC)","The modified Medical Research Council (mMRC) dyspnea scale consists of 4 levels that describe respiratory difficulty during daily activities; higher levels indicate more severe symptoms.",{"measure":72,"description":73,"timeFrame":12},"Short Form-36 (SF-36)","The Short Form-36 (SF-36) measures physical and social health status, with higher scores representing better overall health",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":78,"observationalModel":74,"timePerspective":74,"maskingInfo":79},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":80,"maskingDescription":74,"whoMasked":74},"NONE","Chronic kidney disease (CKD) is a condition characterized by impaired kidney function lasting for more than 3 months, as estimated by the glomerular filtration rate (eGFR), which is classified into stages 1 to 5. Common symptoms include swelling, fatigue, and high blood pressure. Previous studies have indicated that physical inactivity in patients with CKD, often due to fatigue, leads to decreased physical fitness. In addition, secondary complications such as muscle mass loss and weakness are frequently observed, especially in the advanced stages of CKD.\n\nTo address this vicious cycle, aerobic and resistance training have been shown to mitigate these effects. Previous studies have reported that such exercise interventions can reduce fatigue and improve VO₂ peak in individuals with CKD. However, these exercise programs often involve high loads and frequencies, which may not be feasible for some CKD patients, particularly those with comorbidities such as diabetes or cardiovascular disease.\n\nThe effectiveness of blood flow restriction (BFR) exercise compared with high-load training has been demonstrated in older adults, showing improvements in functional ability and muscular adaptation. Therefore, the purpose of this study is to investigate the effects of incorporating blood flow restriction during exercise on cardiopulmonary function and exercise capacity in patients with CKD.",[83,92,97,101],{"label":84,"type":85,"description":86,"interventionNames":87},"healthy","EXPERIMENTAL","We will provide BFR combined with exercise",[88,89,90,91],"Behavioral: Aerobic exercise","Behavioral: Blood flow restriction","Behavioral: Resistance exercise","Behavioral: Disease and exercise suggestion",{"label":93,"type":94,"description":95,"interventionNames":96},"CKD usual care group","ACTIVE_COMPARATOR","We will provide patient education, home-based moderate to low-intensity rehabilitation",[91],{"label":98,"type":94,"description":99,"interventionNames":100},"CKD traditional rehabilitation group","We will provide aerobic exercise, resistance exercise training, and patient education",[88,90,91],{"label":102,"type":85,"description":103,"interventionNames":104},"CKD BFR group","We will provide BFR combined with exercise and patient education",[88,89,90],[106,111,115,119],{"type":107,"name":108,"description":109,"armGroupLabels":110,"otherNames":74},"BEHAVIORAL","Aerobic exercise","The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks",[102,98,84],{"type":107,"name":112,"description":113,"armGroupLabels":114,"otherNames":74},"Blood flow restriction","Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks",[102,84],{"type":107,"name":116,"description":117,"armGroupLabels":118,"otherNames":74},"Resistance exercise","The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks",[102,98,84],{"type":107,"name":120,"description":121,"armGroupLabels":122,"otherNames":74},"Disease and exercise suggestion","The participants will received self-care technique and home-based exercise approach",[98,93,84],[124],{"name":125,"affiliation":126,"role":127},"Kun-Ling Tasi, PhD","Department of Physical Therapy, National Cheng Kung University","PRINCIPAL_INVESTIGATOR",[129,133],{"name":125,"role":130,"phone":131,"phoneExt":74,"email":132},"CONTACT","886-6-2353535 Ext.5078","Kunlingtsai@mail.ncku.edu.tw",{"name":134,"role":130,"phone":131,"phoneExt":74,"email":135},"Ting-Ying Wu, B.S","t66131036@gs.ncku.edu.tw",[137],{"facility":138,"status":139,"city":140,"state":74,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":149,"contacts":150},"National Cheng Kung University Hospital","RECRUITING","Tainan","701","Taiwan","TW",{"type":145,"coordinates":146},"Point",[147,148],120.21333,22.99083,{"lat":148,"lon":147},[151],{"name":125,"role":130,"phone":152,"phoneExt":74,"email":132},"062353535 Ext. 6219",{"type":127,"investigatorFullName":154,"investigatorTitle":155,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"Kun-Ling Tsai","Professor and Chair, Department of Physical Therapy","100615153",false,"NCT07288905","Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD","The Feasibility and Effects of Exercise Training Combined With Blood Flow Restriction Training on Exercise Capacity and Exercise Tolerance in Patients With Chronic Kidney Disease","Healthy\n\nInclusion Criteria:\n\n• Aged 20\\~85 years old\n\nExclusion Criteria:\n\n* Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)\n* Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)\n* Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months\n* Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)\n* Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate \\>100 bpm)\n* Prone to bruising\n* Recent inflection \\\u003C 1 month\n* Pregnancy\n* Kidney function impairment\n* Cancer\n* Simultaneously participating in other research\n\nCKD\n\nInclusion criteria:\n\n* Aged 20\\~85 years old\n* eGFR\\\u003C 90 ml\u002Fmin\u002F1.73 m2 over 3 months\n* Stable condition without worsening in the past 3 months\n* Ability to understand and follow verbal commends and cooperate with an exercise training program\n\nExclusion criteria:\n\n* Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)\n* Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)\n* Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months\n* Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)\n* Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate \\>100 bpm)\n* Abnormal blood biochemical parameters (e.g., white blood cell count \\\u003C2500\u002Fmm³, hemoglobin \\\u003C8 mg\u002FdL, total bilirubin \\>3 mg\u002FdL, liver enzymes (GOT\u002FAST, GPT\u002FALT) \\>3 times the upper limit of normal, platelet count \\\u003C75,000\u002Fmm³\n* Sensory or motor dysfunctions that affect walking ability\n* Diagnosed systemic diseases under ongoing treatment (e.g., systemic lupus erythematosus, cancer, malignancies).",true,"ALL","20 Years","85 Years",{"count":167,"type":168},120,"ESTIMATED","INTERVENTIONAL",[171],"NA","Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients",[174],"Chronic Kidney Disease","2025-12-03",{"date":177,"type":178},"2025-12-17","ACTUAL",{"date":180,"type":178},"2025-10-04",{"date":182,"type":168},"2030-12-31",{"name":5,"class":6},1]