Randomized controlled trial on Dryland And Thermal Aquatic standardized exercise protocol for chronic venous disease (DATA study)

Abstract

Objective: The present investigation aims to compare the effect of a standardized exercise protocol in thermal aquatic immersion vs dryland (DL) on patients with chronic venous disease (CVD).

Methods: Thirty-four patients with CVD (C3,Ep,As,Pr) were included in the study and randomly assigned to perform a standardized exercise protocol in a DL environment (DL group) or in a thermal water (TW group) from a natural hot spring at 33°C with a high mineral content. Leg volumetry, ankle range of motion (ROM), ultrasound-detected subcutaneous tissue and great saphenous vein (GSV) diameter were assessed. Quality of life was measured by VVSymQ and CIVIQ-20.

Results: After five TW sessions the average volume decrease was -432.4 ± 122.4 mL (P < .0001) in the right leg and -358.8 ± 109.3 mL (P < .0001) in the left. No significant volume change was reported at the end of the five sessions in DL. In TW, the subcutaneous tissue thickness significantly decreased (all assessment points P < .0001 right and P < .0001 left). In contrast, no significant changes were found in the DL group. The TW group showed a significant great saphenous vein caliber reduction, both in the right and left legs (6.2 ± 5.9%, P < .002; 6.1 ± 2.2%, P < .0001), whereas in the DL group no significant differences were found. After five sessions, ankle ROM significantly increased in both groups, both in dorsiflexion and in plantarflexion (right leg: TW_dorsiflexionP < .0001, TW_{plantarflexion}P < .0001; DL_dorsiflexionP < .003, DL_{plantarflexion}P < .007) (left leg: TW_dorsiflexionP < .0001, TW_{plantarflexion}P < .0001; DL_dorsiflexionP < .006, DL_{plantarflexion}P < .001). Only the TW group showed a linear correlation between volume and ankle ROM variation (right leg: R² = 0.80, R² = 0.75, P < .0001; left leg: R² = 0.82, R² = 0.81, P < .0001). The VVSymQ and CIVQ20 scores significantly improved in TW (P < .0001 and P < .0001, respectively), whereas DL showed a significant improvement only in CIVQ20 score (P < .02).

Conclusions: Thermal aquatic immersion enhances the clinical benefits of a standardized exercise protocol for patients with CVD. Compared with the data available in the literature on non-TW, the present investigation shows a potential role of higher density types of water in lower limb volume control. Intense and rigorous data collection is needed to move from empirical evidence to evidence-based science in TW, a potentially very useful treatment modality for CVD.

Keywords: Chronic venous insufficiency; Edema; Exercise; Thermal water; Volume.