The ATLANTIS Trial

Not Applicable

Completed

• Conditions: Venous Reflux; Chronic Venous Hypertension Due to Deep Vein Thrombosis
• Interventions: Other: aquatic activity plus conventional management; Other: exercise in water

• Registration Number: NCT02553720
• Lead Sponsor: Arizona Cardiovascular Consultants

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2016-07
• Study Completion: 2018-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	aquatic activity plus conventional management	Conventional management without aquatic exercise
Aquatic Group	exercise in water	Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months
Aquatic Group	aquatic activity plus conventional management	Conventional management plus aquatic exercise At least 15 minutes of walking 3 times/week for 3 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arizona cardiovascular consultants; 🇺🇸 Mesa, Arizona, United States