The ATLANTIS Trial

Venous Reflux Clinical Trial

— ATLANTIS  

Official title:

Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553720
• Other study ID #: ArizonaCC
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2020
• Source: Arizona Cardiovascular Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: January 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Hypertension Due to Deep Vein Thrombosis
• Thrombosis
• Venous Reflux
• Venous Thrombosis

Intervention

Other:
• exercise in water
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
• aquatic activity plus conventional management
walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management

Locations

Country	Name	City	State
United States	Arizona cardiovascular consultants	Mesa	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona Cardiovascular Consultants	A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Erratum in: Lancet. 2013 Aug 10;382(9891):506. Lancet. 2013 Sep 21;382(9897):1020. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 point drop in modified VCSS	Modified VCSS score at baseline, 3 m and 2 years.	3 months and 2 years
Secondary	Viallta Score	Changes in the Vllalta scoring system	3 months and 2 years
Secondary	Mortality	Development of death at follow up.	2 years
Secondary	VEINES QOL/Sym	changes of time velocity integral of the spectral Doppler waveform.	3months and 2 years
Secondary	Recurrent venous thromboembolic disease	Measured objectively by venous duplex or CT angiography or V/Q scan if indicated	3 months and 2 years
Secondary	Modified Venous Clinical Severity Score	Changes in absolute scores before and after intervention	3months and 2 years
Secondary	SF 36 questionnaire-PHC	Changes in score before and after intervention	3 months and 2 years
Secondary	Thigh and leg circumference	Changes in circumference before and after intervention	3 months and 2 years
Secondary	"Subjective Index" alteration	Changes in score before and after intervention	3 months and 2 years