Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-02 @ 5:55 PM
Study NCT ID:
NCT02553720
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2015-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ATLANTIS Trial
Sponsor:
Arizona Cardiovascular Consultants
Organization:
Study Overview
Official Title:
Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATLANTIS
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: