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

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 degrees 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: TWdorsiflexion P<.0001, TWplantarflexion P<.0001; DLdorsiflexion P<.003, DLplantarflexion P<.007) (left leg: TWdorsiflexion P<.0001, TWplantarflexion P<.0001; DLdorsiflexion P<.006, DLplantarflexion P<.001). Only the TW group showed a linear correlation between volume and ankle ROM variation (right leg: R-2 = 0.80, R-2 = 0.75, P<.0001; left leg: R-2 = 0.82, R-2 = 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.

Automated summary

The study demonstrates that thermal aquatic immersion has a positive impact on the clinical outcomes of patients with chronic venous disease, helping to reduce lower limb volume and improve disease management. Additionally, the research results also show significant improvements in ankle range of motion and quality of life for patients undergoing thermal water immersion.