Clinical Trial: Aqua Therapy in Deep Venous Thrombosis and Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Aqua Therapy to Lower Adverse and Negative Effects of Deep Vein ThrombosIs and Post Thrombotic Syndrome

Brief Summary: The purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of deep vein thrombosis and reduce the severity of chronic venous insufficiency.

Detailed Summary: 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 compression stockings . 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 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 edema would be faster. There are no data on the role of water activity in the reduction of measures of venous insufficiency.The purpose of this study is to assess whether the encouragement of patients to perform aqua activity above and beyond the recommended treatment would positively impact chronic venous insufficiency.
Sponsor: Arizona Cardiovascular Consultants

Current Primary Outcome: Changes in leg volumes [ Time Frame: 6 months and 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Post-thrombotic syndromedisease [ Time Frame: 6 months and 2 years ]
    Changes in the Vllalta scoring system
  • Mortality [ Time Frame: 6 months and 2 years ]
  • Venous reflux [ Time Frame: 6 months and 2 years ]
    Grade of reflux ( mild, moderate, severe ) assessed by the area under the curve of of time velocity integral of the spectral Doppler waveform.
  • Recurrent venous thromboembolic disease [ Time Frame: 6 months and 2 years ]
    Measured objectively by venous duplex or CT angiography or V/Q scan
  • Modified Venous Clinical Severity Score [ Time Frame: 6 months and 2 years ]
    Changes in score before and after intervention
  • SF 36 questionnaire [ Time Frame: 6 months and 2 years ]
    Changes in score before and after intervention


Original Secondary Outcome: Same as current

Information By: Arizona Cardiovascular Consultants

Dates:
Date Received: September 10, 2015
Date Started: September 2015
Date Completion: December 2017
Last Updated: September 17, 2015
Last Verified: September 2015