Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-03 @ 2:31 AM
Study NCT ID:
NCT02553720
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2015-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ATLANTIS Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054070', 'term': 'Postthrombotic Syndrome'}], 'ancestors': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D014867', 'term': 'Water'}], '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': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 201 patients were randomized with 100 to the Aquatic Group and 101 to the Control Group. At 24 months, 91 patients had completion of evaluation in the Aquatic Group and 90 patients in the Control Group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2015-09-10', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '4 point drop in modified VCSS', 'timeFrame': '3 months and 2 years', 'description': 'Modified VCSS score at baseline, 3 m and 2 years.'}], 'secondaryOutcomes': [{'measure': 'Viallta Score', 'timeFrame': '3 months and 2 years', 'description': 'Changes in the Vllalta scoring system'}, {'measure': 'Mortality', 'timeFrame': '2 years', 'description': 'Development of death at follow up.'}, {'measure': 'VEINES QOL/Sym', 'timeFrame': '3months and 2 years', 'description': 'changes of time velocity integral of the spectral Doppler waveform.'}, {'measure': 'Recurrent venous thromboembolic disease', 'timeFrame': '3 months and 2 years', 'description': 'Measured objectively by venous duplex or CT angiography or V/Q scan if indicated'}, {'measure': 'Modified Venous Clinical Severity Score', 'timeFrame': '3months and 2 years', 'description': 'Changes in absolute scores before and after intervention'}, {'measure': 'SF 36 questionnaire-PHC', 'timeFrame': '3 months and 2 years', 'description': 'Changes in score before and after intervention'}, {'measure': 'Thigh and leg circumference', 'timeFrame': '3 months and 2 years', 'description': 'Changes in circumference before and after intervention'}, {'measure': '"Subjective Index" alteration', 'timeFrame': '3 months and 2 years', 'description': 'Changes in score before and after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post thrombotic syndrome', 'Chronic venous insufficiency'], 'conditions': ['Chronic Venous Hypertension Due to Deep Vein Thrombosis', 'Venous Reflux']}, 'referencesModule': {'references': [{'pmid': '25016993', 'type': 'BACKGROUND', 'citation': "Kahn SR, Shapiro S, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome - Authors' reply. Lancet. 2014 Jul 12;384(9938):130-1. doi: 10.1016/S0140-6736(14)61160-0. No abstract available."}, {'pmid': '23727163', 'type': 'BACKGROUND', 'citation': 'CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration; Dennis M, Sandercock P, Reid J, Graham C, Forbes J, Murray G. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. Lancet. 2013 Aug 10;382(9891):516-24. doi: 10.1016/S0140-6736(13)61050-8. Epub 2013 May 31.'}, {'pmid': '15183623', 'type': 'BACKGROUND', 'citation': 'Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.'}, {'pmid': '22545895', 'type': 'RESULT', 'citation': 'Sharifi M, Bay C, Mehdipour M, Sharifi J; TORPEDO Investigators. Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion (TORPEDO) trial: midterm results. J Endovasc Ther. 2012 Apr;19(2):273-80. doi: 10.1583/11-3674MR.1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including CVI resulting from venous thrombosis.', 'detailedDescription': 'Post-thrombotic syndrome (PTS) develops in approximately 25-60% of patients with acute lower extremity deep venous thrombosis (DVT) depending on severity, chronicity, anatomic level of involvement and efficacy of anticoagulation.The frequency increases with occlusive iliac venous thrombosis. PTS results in significant morbidity and a staggering toll on health careresources . PTS is reduced by early percutaneous endovenous intervention and administration of new oral anticoagulants. There are conflicting results on the efficacy of exercise . In general, exercise has been useful in activation of the muscle pump and improvement of symptoms. There are no data about exercise in a swimming pool. Both walking in water or swimming reduce the effect of joint contact and therefore pain which is particularly useful in patients with arthritis or heavyweight. Furthermore with less effect of gravity, absorption of dependent edema would be faster. Dry skin becomes hydrated and the chlorine of water can exert antiseptic properties. There are no data on the role of aquatic activity in the reduction of measures of venous insufficiency.The purpose of this study is to assess whether encouragement of patients to perform aquatic activity in addition to baseline treatment would positively impact chronic venous insufficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage\\>18 years; a Villalta score of ˃5 or a modified Venous Clinical Severity Score (VCSS) of ˃5 plus ongoing symptoms of ˃3 months despite receiving conservative management (minimum of 2 of the following: compression stockings, leg elevation, physical activity on land and use of non-steroidal anti-inflammatory drugs where appropriate, for the preceding 3 months).\n\nExclusion criteria consisted of unwillingness or inability to use or no access to a swimming pool; open ulceration; planned intervention for arterial or superficial venous reflux, deep venous thrombosis (DVT), venous stenosis, pelvic congestion syndrome, within the first 3 months of enrolment; or using a swimming pool on a regular basis.'}, 'identificationModule': {'nctId': 'NCT02553720', 'acronym': 'ATLANTIS', 'briefTitle': 'The ATLANTIS Trial', 'organization': {'class': 'OTHER', 'fullName': 'Arizona Cardiovascular Consultants'}, 'officialTitle': 'Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency', 'orgStudyIdInfo': {'id': 'ArizonaCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquatic Group', 'description': 'Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months', 'interventionNames': ['Other: exercise in water', 'Other: aquatic activity plus conventional management']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Conventional management without aquatic exercise', 'interventionNames': ['Other: aquatic activity plus conventional management']}], 'interventions': [{'name': 'exercise in water', 'type': 'OTHER', 'otherNames': ['aquatic activity'], 'description': 'The patients will be instructed to perform walking or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management', 'armGroupLabels': ['Aquatic Group']}, {'name': 'aquatic activity plus conventional management', 'type': 'OTHER', 'description': 'walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management', 'armGroupLabels': ['Aquatic Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona cardiovascular consultants', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}], 'overallOfficials': [{'name': 'Mohsen SHARIFI, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona Cardiovascular Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona Cardiovascular Consultants', 'class': 'OTHER'}, 'collaborators': [{'name': 'A.T. Still University of Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohsen Sharifi MD', 'investigatorAffiliation': 'Arizona Cardiovascular Consultants'}}}}