The ATLANTIS Trial

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Venous Hypertension Due to Deep Vein Thrombosis, Venous Reflux

Intervention / Treatment
-----------------
* Other: exercise in water
* Other: aquatic activity plus conventional management


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic Group<br>Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months | Other: exercise in water<br>* 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<br>* Other names: aquatic activity;Other: aquatic activity plus conventional management<br>* walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management<br>|
| Other: Control Group<br>Conventional management without aquatic exercise | Other: aquatic activity plus conventional management<br>* walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 point drop in modified VCSS | Modified VCSS score at baseline, 3 m and 2 years. | 3 months and 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post thrombotic syndrome, Chronic venous insufficiency