Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT07259356
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-02
First Post:
2025-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Blood-Flow-Restriction Training in Patients With Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain threshold', 'timeFrame': 'Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention', 'description': 'Pain threshold measurement (PTT): The test determines the amount of pressure (in kg) over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation.'}, {'measure': 'Quality of Life Score', 'timeFrame': 'Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention', 'description': 'Hemophilia Joint Health Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemophilia']}, 'descriptionModule': {'briefSummary': 'In the course of a cross-over study design, 12 patients with hemophilic arthropathy will perform a training load on the knee extensor muscles. The subjects will each perform one intervention with blood flow restriction and one with a Sham-BFR intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with haemophilia\n* Ability for an exercise intervention\n\nExclusion Criteria:\n\n* Sickle Cell Anemia\n* Intravascular stents/bypasses\n* Open Wounds/Infections of the lower extremity'}, 'identificationModule': {'nctId': 'NCT07259356', 'briefTitle': 'Feasibility and Safety of Blood-Flow-Restriction Training in Patients With Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Effect of Blood Flow Restriction Training on the Subjective Perception of Pain in Hemophilic Arthropathy of the Knee Joint', 'orgStudyIdInfo': {'id': '2024_H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Condition', 'description': 'Sham-BFR Leg Press Exercise', 'interventionNames': ['Device: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Condition', 'description': 'BFR Leg Press Exercise', 'interventionNames': ['Device: BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)']}], 'interventions': [{'name': 'Control', 'type': 'DEVICE', 'description': 'Sham-BFR Exercise (20mmHg) while Leg Press Exercise (4 Sets, All out)', 'armGroupLabels': ['Control Condition']}, {'name': 'BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)', 'type': 'DEVICE', 'description': 'BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)', 'armGroupLabels': ['Intervention Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Alexander Franz', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}