Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT04215133
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2019-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training Versus Calf Muscle on Venous Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2019-12-25', 'studyFirstSubmitQcDate': '2019-12-28', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)', 'timeFrame': '12 months', 'description': 'Quality of life'}, {'measure': 'Photoplethysmograph (PPG)', 'timeFrame': '12 months', 'description': 'venous return time'}], 'secondaryOutcomes': [{'measure': 'Hand held dynamometer', 'timeFrame': '12 months', 'description': 'muscle strength'}, {'measure': 'Venous Clinical Severity Score (VCSS)', 'timeFrame': '12 months', 'description': 'clinical severity'}, {'measure': '6 minutes walk test', 'timeFrame': '12 months', 'description': 'functional capacity'}, {'measure': 'digital goniometer', 'timeFrame': '12 months', 'description': 'range of motion of ankle'}, {'measure': 'visual analog scale', 'timeFrame': '12 months', 'description': 'pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['venous insufficiency', 'exercise therapy', 'inspiratory muscle', 'kalf muscle', 'venous return'], 'conditions': ['Venous Insufficiency']}, 'referencesModule': {'references': [{'pmid': '35710091', 'type': 'DERIVED', 'citation': 'Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging\n* CEAP classification used in venous insufficiency is C2-C3-C4-C5\n* Having written and verbal communication in Turkish\n\nExclusion Criteria:\n\n* Acute deep vein thrombosis\n* The presence of ulceration\n* Being in class III and IV according to the New York Heart Association classification\n* Presence of respiratory failure\n* Undergoing chemotherapy due to the presence of any cancer\n* Being in the process of treatment for neurological, orthopedic or rheumatologic diseases including lower extremity'}, 'identificationModule': {'nctId': 'NCT04215133', 'briefTitle': 'Inspiratory Muscle Training Versus Calf Muscle on Venous Function', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency', 'orgStudyIdInfo': {'id': 'IstanbulUCe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'İnspiratory muscle training group', 'interventionNames': ['Other: exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Calf muscle training group', 'interventionNames': ['Other: exercise therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'exercise therapy', 'type': 'OTHER', 'description': 'inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.', 'armGroupLabels': ['Calf muscle training group', 'İnspiratory muscle training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34959', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'GAMZE AYDIN', 'role': 'CONTACT', 'email': 'gmzetsn@gmail.com', 'phone': '05377600256'}], 'facility': 'Istanbul University Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'GAMZE AYDIN, MSc', 'role': 'CONTACT', 'email': 'gmzetsn@gmail.com', 'phone': '+905377600256'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Gamze Aydin', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}