Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT06986395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction Training for Age-Related Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Handgrip Strength', 'timeFrame': 'Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)'}], 'secondaryOutcomes': [{'measure': '6-Meter Walking Speed', 'timeFrame': 'Baseline (Week 0), Follow-up (Week 12)'}, {'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)'}, {'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': 'Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)'}, {'measure': 'MBI', 'timeFrame': 'Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia in Elderly']}, 'descriptionModule': {'briefSummary': "Brief Title: Safe Exercise for Age-Related Muscle Loss in Hospitalized Seniors\n\nSummary:\n\nThis study compares two exercise methods to help older hospital patients (age 65+) rebuild muscle strength after being diagnosed with sarcopenia (age-related muscle loss). We want to know if using special pressure cuffs during light exercise works better than traditional strength training alone.\n\nWho Can Join:\n\nHospitalized seniors with stable health conditions Excludes those with severe disabilities, dementia, or certain blood circulation problems\n\nWhat We'll Do:\n\n40 participants will be randomly assigned to either:\n\nTraditional Training Group:\n\nUses weights/bands at 65-75% max capacity Arm/leg exercises 3x/week for 4 weeks\n\nPressure Cuff Training Group:\n\nUses special cuffs on arms/thighs during lighter exercises (20% max capacity) Same exercise frequency with controlled pressure for safety\n\nWhat We'll Measure:\n\nHandgrip strength (main test at 0/4/12 weeks) Walking speed, balance tests, quality of life surveys Any side effects like dizziness/nausea\n\nSafety First:\n\nDoctors will check your health before starting. Nurses will monitor every session. We use medical-grade cuffs with safe pressure limits (arm: 80-100mmHg, thigh: 150-200mmHg). You can stop anytime if uncomfortable.\n\nWhy This Matters:\n\nThis could help hospitalized seniors regain strength faster using gentler exercises. All activities are supervised by rehabilitation specialists at West China Hospital, with ethics committee approval (IRB number required)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients aged ≥65 years\n* Diagnosed with sarcopenia per EWGSOP2019 criteria\n* Acute medical conditions stabilized for ≥4 weeks (e.g., resolved infections, controlled heart failure)\n\nExclusion Criteria:\n\n* Severe disability (Barthel Index ≤40)\n* Significant cognitive impairment (MMSE ≤18) or major psychiatric disorders (DSM-5 criteria)\n* Contraindications to blood flow restriction training:\n\n * History/predisposition to deep vein thrombosis\n * Coagulopathy (INR \\>1.5, platelets \\<100×10⁹/L)\n * Symptomatic varicose veins (CEAP class C4-C6)\n * Uncontrolled hypertension (BP \\>160/100 mmHg)\n * Chronic lymphedema (ISL stage II-III)\n * Peripheral artery disease (ABI ≤0.7)\n * Active systemic infection (CRP \\>10 mg/L)\n * Malignancy (except non-melanoma skin cancer)\n * Severe renal impairment (eGFR \\<30 mL/min/1.73m²)\n * Acute coronary syndrome within 3 months'}, 'identificationModule': {'nctId': 'NCT06986395', 'briefTitle': 'Blood Flow Restriction Training for Age-Related Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'The Efficacy of Blood Flow Restriction Training in Elderly Patients With Sarcopenia.', 'orgStudyIdInfo': {'id': '20241201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFRT Group', 'description': '"Blood flow restriction training with 20% 1RM loading, pneumatic cuff pressure 80-100mmHg (arms)', 'interventionNames': ['Device: Blood Flow Restriction Training (BFRT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CRT Group', 'description': 'Conventional resistance training at 65-75% 1RM intensity using weights/elastic bands, matched frequency/duration', 'interventionNames': ['Other: Conventional Resistance Training (CRT)']}], 'interventions': [{'name': 'Blood Flow Restriction Training (BFRT)', 'type': 'DEVICE', 'description': 'Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands', 'armGroupLabels': ['BFRT Group']}, {'name': 'Conventional Resistance Training (CRT)', 'type': 'OTHER', 'description': 'Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands', 'armGroupLabels': ['CRT Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yu liang', 'role': 'CONTACT', 'email': '1536569213@qq.com', 'phone': '+86 13982250862'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist-in-Charge', 'investigatorFullName': 'Yuxiang Liang', 'investigatorAffiliation': 'West China Hospital'}}}}