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The ATLANTIS Trial (ATLANTIS)

Primary Purpose

Chronic Venous Hypertension Due to Deep Vein Thrombosis, Venous Reflux

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise in water
aquatic activity plus conventional management
Sponsored by
Arizona Cardiovascular Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Hypertension Due to Deep Vein Thrombosis focused on measuring Post thrombotic syndrome, Chronic venous insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona cardiovascular consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Aquatic Group

Control Group

Arm Description

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

Conventional management without aquatic exercise

Outcomes

Primary Outcome Measures

4 point drop in modified VCSS
Modified VCSS score at baseline, 3 m and 2 years.

Secondary Outcome Measures

Viallta Score
Changes in the Vllalta scoring system
Mortality
Development of death at follow up.
VEINES QOL/Sym
changes of time velocity integral of the spectral Doppler waveform.
Recurrent venous thromboembolic disease
Measured objectively by venous duplex or CT angiography or V/Q scan if indicated
Modified Venous Clinical Severity Score
Changes in absolute scores before and after intervention
SF 36 questionnaire-PHC
Changes in score before and after intervention
Thigh and leg circumference
Changes in circumference before and after intervention
"Subjective Index" alteration
Changes in score before and after intervention

Full Information

First Posted
September 10, 2015
Last Updated
July 21, 2020
Sponsor
Arizona Cardiovascular Consultants
Collaborators
A.T. Still University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02553720
Brief Title
The ATLANTIS Trial
Acronym
ATLANTIS
Official Title
Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona Cardiovascular Consultants
Collaborators
A.T. Still University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Hypertension Due to Deep Vein Thrombosis, Venous Reflux
Keywords
Post thrombotic syndrome, Chronic venous insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Group
Arm Type
Experimental
Arm Description
Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months
Arm Title
Control Group
Arm Type
Other
Arm Description
Conventional management without aquatic exercise
Intervention Type
Other
Intervention Name(s)
exercise in water
Other Intervention Name(s)
aquatic activity
Intervention 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
Intervention Type
Other
Intervention Name(s)
aquatic activity plus conventional management
Intervention 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
Primary Outcome Measure Information:
Title
4 point drop in modified VCSS
Description
Modified VCSS score at baseline, 3 m and 2 years.
Time Frame
3 months and 2 years
Secondary Outcome Measure Information:
Title
Viallta Score
Description
Changes in the Vllalta scoring system
Time Frame
3 months and 2 years
Title
Mortality
Description
Development of death at follow up.
Time Frame
2 years
Title
VEINES QOL/Sym
Description
changes of time velocity integral of the spectral Doppler waveform.
Time Frame
3months and 2 years
Title
Recurrent venous thromboembolic disease
Description
Measured objectively by venous duplex or CT angiography or V/Q scan if indicated
Time Frame
3 months and 2 years
Title
Modified Venous Clinical Severity Score
Description
Changes in absolute scores before and after intervention
Time Frame
3months and 2 years
Title
SF 36 questionnaire-PHC
Description
Changes in score before and after intervention
Time Frame
3 months and 2 years
Title
Thigh and leg circumference
Description
Changes in circumference before and after intervention
Time Frame
3 months and 2 years
Title
"Subjective Index" alteration
Description
Changes in score before and after intervention
Time Frame
3 months and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen SHARIFI, M.D.
Organizational Affiliation
Arizona Cardiovascular Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona cardiovascular consultants
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25016993
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.
Results Reference
background
PubMed Identifier
23727163
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.
Results Reference
background
PubMed Identifier
15183623
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.
Results Reference
background
PubMed Identifier
22545895
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.
Results Reference
result

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The ATLANTIS Trial

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