The randomized, controlled ATLANTIS trial of aquatic therapy for chronic venous insufficiency

Abstract

Objective: There are conflicting reports on the efficacy of exercise in chronic venous insufficiency (CVI). Exercise in water or aquatic activity (AA) can have additional advantages. We sought to evaluate the clinical effects of AA in CVI in a randomized prospective open label fashion.

Methods: A total of 201 patients with advanced CVI were randomized to receive AA vs no such treatment. In the Aquatic Group (AG), 91 patients reached the 24-month follow-up point, and in the Control Group (CG), 90 patients did. The primary efficacy end point was a predefined reduction of ≥4 points in the modified Venous Clinical Severity Score (VCSS) at 3 months. Instruments of venous disease severity and quality of life were compared at baseline, 3 months, and 24 months between and within the two groups. These included the modified VCSS, Villalta score, leg and thigh circumference, the Physical Health Component of the 36-Item Short Form Health Survey, and the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptom scores. Aquatic activity consisted of a minimum of 15 minutes of walking in a swimming pool at 1 m/s, 3 times/wk for 3 months.

Results: The primary end point of 4-point reduction in the modified VCSS at 3 months was reached in 28% of AG and 3% of CG (odds ratio = 12.08; 95% confidence interval: 3.51, 41.59; P < .001). Comparison of changes in secondary end points from baseline to 24 months between AG and CG demonstrated the following: modified VCSS -4.08 ± 2.08 vs -1.15 ± 1.26, Villalta score -4.00 ± 2.68 vs -1.01 ± 1.34, thigh circumference -3.40 ± 1.78 cm vs -1.40 ± 2.55 cm, leg circumference -1.27 ± 1.34 cm vs -0.49 ± 1.21 cm, Physical Health Component of the 36-Item Short Form Health Survey 3.82 ± 2.36 vs 1.16 ± 1.18, Venous Insufficiency Epidemiological and Economic Study Quality of Life 3.35 ± 1.67 vs 1.30 ± 1.43, and Venous Insufficiency Epidemiological and Economic Study Symptom 3.53 ± 1.71 vs 1.23 ± 1.26 (P < .001 for all comparisons; ± denotes mean ± standard deviation).

Conclusions: The addition of AA to the treatment of patients with advanced CVI is safe and effective, leading to a significant improvement in clinical status and quality of life. These beneficial changes occur rapidly within 3 months of initiation of AA and are continued at a slower rate of improvement from 3 months to 2 years.

Keywords: Chronic venous insufficiency; Modified VCSS; Post-thrombotic syndrome; Subjective Index; Villalta score.