Chronic Venous Hypertension Due to Deep Vein Thrombosis, Venous Reflux
Conditions
Keywords
Post thrombotic syndrome, Chronic venous insufficiency
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.
Interventions
OTHERexercise 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
OTHERaquatic 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
Sponsors
A.T. Still University of Health Sciences
Arizona Cardiovascular Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A total of 201 patients were randomized with 100 to the Aquatic Group and 101 to the Control Group. At 24 months, 91 patients had completion of evaluation in the Aquatic Group and 90 patients in the Control Group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4 point drop in modified VCSS | 3 months and 2 years | Modified VCSS score at baseline, 3 m and 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 2 years | Development of death at follow up. |
| VEINES QOL/Sym | 3months and 2 years | changes of time velocity integral of the spectral Doppler waveform. |
| Recurrent venous thromboembolic disease | 3 months and 2 years | Measured objectively by venous duplex or CT angiography or V/Q scan if indicated |
| Viallta Score | 3 months and 2 years | Changes in the Vllalta scoring system |
| SF 36 questionnaire-PHC | 3 months and 2 years | Changes in score before and after intervention |
| Thigh and leg circumference | 3 months and 2 years | Changes in circumference before and after intervention |
| Subjective Index alteration | 3 months and 2 years | Changes in score before and after intervention |
| Modified Venous Clinical Severity Score | 3months and 2 years | Changes in absolute scores before and after intervention |
Countries
United States
Outcome results
None listed