The ATLANTIS Trial

NCT02553720 | Completed

• 1 other identifier: ArizonaCC
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Hypertension Due to Deep Vein Thrombosis; Venous Reflux

Keywords

Post thrombotic syndrome; Chronic venous insufficiency

Outcome Measures

Primary Outcomes (1)

• 4 point drop in modified VCSS

  Modified VCSS score at baseline, 3 m and 2 years.

  3 months and 2 years

Secondary Outcomes (8)

• Viallta Score

  3 months and 2 years

• Mortality

  2 years

• VEINES QOL/Sym

  3months and 2 years

• Recurrent venous thromboembolic disease

  3 months and 2 years

• Modified Venous Clinical Severity Score

  3months and 2 years

Study Arms (2)

Aquatic Group

EXPERIMENTAL

Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months

Other: exercise in water; Other: aquatic activity plus conventional management

Control Group

OTHER

Conventional management without aquatic exercise

Other: aquatic activity plus conventional management

Interventions

exercise in water OTHER

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

Also known as: aquatic activity

Aquatic Group

aquatic activity plus conventional management OTHER

walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management

Aquatic Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Arizona Cardiovascular Consultants: lead
• A.T. Still University of Health Sciences: collaborator

Study Sites (1)

Arizona cardiovascular consultants

Mesa, Arizona, 85206, United States

Location

Related Publications (4)

• 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: 25016993 BACKGROUND

• 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: 23727163 BACKGROUND

• 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: 15183623 BACKGROUND

• 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.

  PMID: 22545895 RESULT

MeSH Terms

Conditions

Postthrombotic Syndrome

Interventions

Exercise; Water

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Mohsen SHARIFI, M.D.

  Arizona Cardiovascular Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2018
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

US (1)