Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT07288905
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm excursion and thickness', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': 'Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration'}, {'measure': 'Exercise capacity', 'timeFrame': 'Change form baseline (0 week) to follow up (16 weeks)', 'description': 'A cardiopulmonary exercise test collects gases (including measures of oxygen consumption in ml/kg/min), which can be used to estimate exercise capacity'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)', 'timeFrame': 'Change form baseline (0 week) to follow up (16 weeks)', 'description': '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': 'Heart rate variability (Root Mean Square of Successive Differences, RMSSD)', 'timeFrame': 'Change form baseline (0 week) to follow up (16 weeks)', 'description': 'Root Mean Square of Successive Differences (RMSSD in ms) represents short-term HRV and parasympathetic activity'}, {'measure': 'Heart rate variability (Low Frequency power, LF)', 'timeFrame': 'Change form baseline (0 week) to follow up (16 weeks)', 'description': 'Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation.'}, {'measure': 'Heart rate variability (High Frequency power, HF)', 'timeFrame': 'Change from baseline (0 week) to follow-up (16 weeks)', 'description': 'High frequency power (HF in ms²) reflects parasympathetic (vagal) activity.'}, {'measure': 'Heart rate variability (LF/HF Ratio)', 'timeFrame': 'Change from baseline (0 week) to follow-up (16 weeks)', 'description': 'LF/HF ratio represents sympathovagal balance.'}, {'measure': 'Pulmonary function test', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': '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/FEV1 ratio.'}, {'measure': 'Functional capacity', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': 'Functional capacity is examined by 6 minute walking test (6MWT, in m)'}, {'measure': 'Functional ability', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': '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': 'Sit-and-Reach Test', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': 'Flexibility is examined by the sit and reach test (unit: cm).'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Change from baseline (0 week) to follow-up (16 weeks)', 'description': 'Maximal voluntary handgrip strength. (unit: N)'}, {'measure': 'Upper Limb Muscle Strength', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': 'Maximal voluntary contraction of upper limb muscles. (unit: N)'}, {'measure': 'Neck Muscle Strength', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': 'Maximal voluntary contraction of neck muscles. (unit: N)'}, {'measure': 'Knee Extensor Strength', 'timeFrame': 'Change from baseline (0 week) to follow-up (16 weeks)', 'description': 'Maximal voluntary contraction of the knee extensor muscles. (unit: N)'}, {'measure': 'Maximum respiratory pressure', 'timeFrame': 'Change from baseline (0 week) to follow up (20 weeks)', 'description': 'Maximum respiratory pressure is measured using a manometer, which records both maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), in cmH₂O.'}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'Change form baseline (0 week) to follow up (16 weeks)', 'description': "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': 'Kidney Disease Quality of Life (KDQOL)', 'timeFrame': 'Change form baseline (0 week) to follow up (16 weeks)', 'description': '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': 'Modified Medical Research Council (mMRC)', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': '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': 'Short Form-36 (SF-36)', 'timeFrame': 'Change from baseline (0 week) to follow up (16 weeks)', 'description': 'The Short Form-36 (SF-36) measures physical and social health status, with higher scores representing better overall health'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "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 \\< 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\\< 90 ml/min/1.73 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 \\<2500/mm³, hemoglobin \\<8 mg/dL, total bilirubin \\>3 mg/dL, liver enzymes (GOT/AST, GPT/ALT) \\>3 times the upper limit of normal, platelet count \\<75,000/mm³\n* Sensory or motor dysfunctions that affect walking ability\n* Diagnosed systemic diseases under ongoing treatment (e.g., systemic lupus erythematosus, cancer, malignancies)."}, 'identificationModule': {'nctId': 'NCT07288905', 'briefTitle': 'Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng Kung University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'B-ER-113-450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy', 'description': 'We will provide BFR combined with exercise', 'interventionNames': ['Behavioral: Aerobic exercise', 'Behavioral: Blood flow restriction', 'Behavioral: Resistance exercise', 'Behavioral: Disease and exercise suggestion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CKD usual care group', 'description': 'We will provide patient education, home-based moderate to low-intensity rehabilitation', 'interventionNames': ['Behavioral: Disease and exercise suggestion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CKD traditional rehabilitation group', 'description': 'We will provide aerobic exercise, resistance exercise training, and patient education', 'interventionNames': ['Behavioral: Aerobic exercise', 'Behavioral: Resistance exercise', 'Behavioral: Disease and exercise suggestion']}, {'type': 'EXPERIMENTAL', 'label': 'CKD BFR group', 'description': 'We will provide BFR combined with exercise and patient education', 'interventionNames': ['Behavioral: Aerobic exercise', 'Behavioral: Blood flow restriction', 'Behavioral: Resistance exercise']}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'BEHAVIORAL', 'description': 'The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks', 'armGroupLabels': ['CKD BFR group', 'CKD traditional rehabilitation group', 'healthy']}, {'name': 'Blood flow restriction', 'type': 'BEHAVIORAL', 'description': 'Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks', 'armGroupLabels': ['CKD BFR group', 'healthy']}, {'name': 'Resistance exercise', 'type': 'BEHAVIORAL', 'description': 'The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks', 'armGroupLabels': ['CKD BFR group', 'CKD traditional rehabilitation group', 'healthy']}, {'name': 'Disease and exercise suggestion', 'type': 'BEHAVIORAL', 'description': 'The participants will received self-care technique and home-based exercise approach', 'armGroupLabels': ['CKD traditional rehabilitation group', 'CKD usual care group', 'healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kun-Ling Tasi, PhD', 'role': 'CONTACT', 'email': 'Kunlingtsai@mail.ncku.edu.tw', 'phone': '062353535 Ext. 6219'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Kun-Ling Tasi, PhD', 'role': 'CONTACT', 'email': 'Kunlingtsai@mail.ncku.edu.tw', 'phone': '886-6-2353535 Ext.5078'}, {'name': 'Ting-Ying Wu, B.S', 'role': 'CONTACT', 'email': 't66131036@gs.ncku.edu.tw', 'phone': '886-6-2353535 Ext.5078'}], 'overallOfficials': [{'name': 'Kun-Ling Tasi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Therapy, National Cheng Kung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD sharing plan will be decided after summarized data being published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng Kung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Department of Physical Therapy', 'investigatorFullName': 'Kun-Ling Tsai', 'investigatorAffiliation': 'National Cheng Kung University'}}}}