Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-02 @ 6:44 AM
Study NCT ID:
NCT02825706
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2016-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Physiotherapy in Haemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-08-17', 'releaseDate': '2016-07-07'}, {'resetDate': '2016-10-19', 'releaseDate': '2016-08-26'}, {'resetDate': '2018-07-13', 'releaseDate': '2017-09-26'}], 'estimatedResultsFirstSubmitDate': '2016-07-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D055809', 'term': 'Illness Behavior'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline physical condition of joints after treatment and at 6 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after six months follow-up visit', 'description': 'The physical condition of joints was assessed using the Gilbert scale that measures swelling, muscle atrophy, joint crepitus, range of motion, axial deformity and instability. Scores range from 0 to 12 (0 represents no joint injury and 12 represents maximum joint deterioration).'}, {'measure': 'Change from baseline joint pain after treatment and at 6 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after six months follow-up visit', 'description': 'Joint pain was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain at all) to 10 (the worst pain imaginable by the patient).'}, {'measure': 'Change from baseline perception of the quality of life after treatment and at 6 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after six months follow-up visit', 'description': 'The Haemophilia A-36 questionnaire was used to assess the perception of the quality of life. This questionnaire consists of 36 items that assess 9 domains (physical health, daily activities, joint damage and pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health and social relationships).'}, {'measure': 'Change from baseline illness behavior after treatment and at 6 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after six months follow-up visit', 'description': 'To assess illness behavior, patients completed the Illness Behavior Questionnaire (IBQ). This scale consists of 62 items and 8 domains (hypochondriasis, disease conviction, psychological vs. somatic perception of illness, affective inhibition, affective disturbance, denial and irritability).'}, {'measure': 'Change from baseline frequency of bleedings after treatment and at 6 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after six months follow-up visit', 'description': 'The frequency of bleeding is measured with a record which complete the patients, where they indicate the incidence of hematomas and hemarthrosis during the treatment and follow-up.'}], 'secondaryOutcomes': [{'measure': 'Radiological joint deterioration', 'timeFrame': 'Screening visit', 'description': 'All patients had an assessment of radiological joint deterioration using the Pettersson scale. This scale, with scores ranging from 0 (a normal joint) to 13 (maximum joint deterioration), is the most widely used to assess joint degeneration produced by hemophilic arthropathy. The evaluation of radiological joint damage was done at the beginning of the study.'}, {'measure': 'Age', 'timeFrame': 'Screening visit', 'description': 'Age of patients included in the study'}, {'measure': 'Weight', 'timeFrame': 'Screening visit', 'description': 'Weight of the patients'}, {'measure': 'Height', 'timeFrame': 'Screening visit', 'description': 'Height of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemophilia', 'Educational Physiotherapy', 'Pain', 'Quality of life', 'Illness Behaviour', 'Elbow'], 'conditions': ['Haemophilia']}, 'descriptionModule': {'briefSummary': 'Although arthropathy is a serious problem in patients with hemophilia due to the associated morbidity and incapacity, to the best of the investigators knowledge, no studies have looked at the effect of educational physiotherapy for its clinical improvement.\n\nThis contribution presents the results of educational physiotherapy program applied for 15 weeks with home exercises - in patients with hemophilic arthropathy. After treatment, experimental group showed improved a significant reduction of pain, and best quality of life al illness behaviour. During treatment no patient showed elbow haemarthrosis, which underlines the safety of this physiotherapy program.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with hemophilia A or B\n* Patients over 18 years\n* Patients with hemophilic arthropathy with at least 1 involved joint (elbow, knee or ankle)\n* having signed the informed consent document.\n\nExclusion Criteria:\n\n* Patients diagnosed with other congenital bleeding disorders (i.e. von Willebrand disease)\n* Patients who developed antibodies to FVIII or FIX (inhibitors)\n* Those not able to ambulate as a result of hemophilic arthropathy or any other disability'}, 'identificationModule': {'nctId': 'NCT02825706', 'briefTitle': 'Educational Physiotherapy in Haemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Real Fundación Victoria Eugenia'}, 'officialTitle': 'Effectiveness of an Educational Physiotherapy and Home Exercises Program in Adult Patients With Hemophilia: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'EducationalPhys'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The patients in experimental group received 60-minute educational sessions every two weeks about the pathophysiology of hemophilia, clinical manifestations, postural advice and prevention advice to avoid recurrent bleeding. Likewise, doubts on the clinical progress of hemophilic arthropathy, functional limitations and management of joint pain were resolved. In parallel with the educational sessions, patients followed a 15-week home exercise program performed once a day, 6 days a week. The program included muscle stretching exercises; isometric exercises; proprioceptive exercises on one leg with visual support; and a 20-minute walk. Low-intensity exercises with 20-25 repetitions were included.', 'interventionNames': ['Other: Educational physiotherapy group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The patients in the control group did not receive any educational sessions and did no exercise at all at home.'}], 'interventions': [{'name': 'Educational physiotherapy group', 'type': 'OTHER', 'description': '20 patients with hemophilia were randomly allocated to an educational intervention or to a control group. The educational intervention was performed every two weeks during 15-week and home exercises were performed once a day, 6 days a week, in the same time', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Real Fundación Victoria Eugenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Real Fundación Victoria Eugenia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-07-07', 'type': 'RELEASE'}, {'date': '2016-08-17', 'type': 'RESET'}, {'date': '2016-08-26', 'type': 'RELEASE'}, {'date': '2016-10-19', 'type': 'RESET'}, {'date': '2017-09-26', 'type': 'RELEASE'}, {'date': '2018-07-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Real Fundación Victoria Eugenia'}}}}