Arizona cardiovascular consultants
Mesa, Arizona, 85206, United States
NCT Number: NCT02553720
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Mesa, Arizona, 85206, United States
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.
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.
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
walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
Time frame: 3 months and 2 years
Modified VCSS score at baseline, 3 m and 2 years.
Time frame: 3 months and 2 years
Changes in the Vllalta scoring system
Time frame: 2 years
Development of death at follow up.
Time frame: 3months and 2 years
changes of time velocity integral of the spectral Doppler waveform.
Time frame: 3 months and 2 years
Measured objectively by venous duplex or CT angiography or V/Q scan if indicated
Time frame: 3months and 2 years
Changes in absolute scores before and after intervention
Time frame: 3 months and 2 years
Changes in score before and after intervention
Time frame: 3 months and 2 years
Changes in circumference before and after intervention
Time frame: 3 months and 2 years
Changes in score before and after intervention
Arizona Cardiovascular Consultants
Other
Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency
Acronym: ATLANTIS
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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