Clinical trial NCT02553720: The ATLANTIS Trial
Official title: Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Hypertension Due to Deep Vein Thrombosis
Venous Reflux
Keywords: Post thrombotic syndrome
Chronic venous insufficiency
Lead sponsor: Arizona Cardiovascular Consultants
Sponsor class: OTHER
Collaborators: name: A.T. Still University of Health Sciences
First posted: 2015-09-18
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

age\>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).

Exclusion 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.

Primary outcomes:
measure: 4 point drop in modified VCSS
timeFrame: 3 months and 2 years
Secondary outcomes:
measure: Viallta Score
timeFrame: 3 months and 2 years
measure: Mortality
timeFrame: 2 years
measure: VEINES QOL/Sym
timeFrame: 3months and 2 years
measure: Recurrent venous thromboembolic disease
timeFrame: 3 months and 2 years
measure: Modified Venous Clinical Severity Score
timeFrame: 3months and 2 years
measure: SF 36 questionnaire-PHC
timeFrame: 3 months and 2 years
measure: Thigh and leg circumference
timeFrame: 3 months and 2 years
measure: "Subjective Index" alteration
timeFrame: 3 months and 2 years
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona cardiovascular consultants
state: Arizona
Study officials:
affiliation: Arizona Cardiovascular Consultants
name: Mohsen SHARIFI, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.