The ATLANTIS Trial (ATLANTIS)

July 21, 2020 updated by: Mohsen Sharifi MD, Arizona Cardiovascular Consultants

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Arizona cardiovascular consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4 point drop in modified VCSS
Time Frame: 3 months and 2 years
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
Time Frame: 3 months and 2 years
Changes in the Vllalta scoring system
3 months and 2 years
Mortality
Time Frame: 2 years
Development of death at follow up.
2 years
VEINES QOL/Sym
Time Frame: 3months and 2 years
changes of time velocity integral of the spectral Doppler waveform.
3months and 2 years
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
3 months and 2 years
Modified Venous Clinical Severity Score
Time Frame: 3months and 2 years
Changes in absolute scores before and after intervention
3months and 2 years
SF 36 questionnaire-PHC
Time Frame: 3 months and 2 years
Changes in score before and after intervention
3 months and 2 years
Thigh and leg circumference
Time Frame: 3 months and 2 years
Changes in circumference before and after intervention
3 months and 2 years
"Subjective Index" alteration
Time Frame: 3 months and 2 years
Changes in score before and after intervention
3 months and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona Cardiovascular Consultants

Collaborators

A.T. Still University of Health Sciences

Investigators

  • Principal Investigator: Mohsen SHARIFI, M.D., Arizona cardiovascular consultants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArizonaCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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