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Completed

NCT Number: NCT02553720

The ATLANTIS Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona cardiovascular consultants

Mesa, Arizona, 85206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: aquatic activity

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

Primary outcomes

  1. 4 point drop in modified VCSS

    Time frame: 3 months and 2 years

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

Secondary outcomes

  1. Viallta Score

    Time frame: 3 months and 2 years

    Changes in the Vllalta scoring system

  2. Mortality

    Time frame: 2 years

    Development of death at follow up.

  3. VEINES QOL/Sym

    Time frame: 3months and 2 years

    changes of time velocity integral of the spectral Doppler waveform.

  4. Recurrent venous thromboembolic disease

    Time frame: 3 months and 2 years

    Measured objectively by venous duplex or CT angiography or V/Q scan if indicated

  5. Modified Venous Clinical Severity Score

    Time frame: 3months and 2 years

    Changes in absolute scores before and after intervention

  6. SF 36 questionnaire-PHC

    Time frame: 3 months and 2 years

    Changes in score before and after intervention

  7. Thigh and leg circumference

    Time frame: 3 months and 2 years

    Changes in circumference before and after intervention

  8. "Subjective Index" alteration

    Time frame: 3 months and 2 years

    Changes in score before and after intervention

Sponsors and collaborators

Lead sponsor

Arizona Cardiovascular Consultants

Other

Collaborators

  • A.T. Still University of Health Sciences

Registry information

Official study title

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

Acronym: ATLANTIS

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Sep 18, 2015
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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