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

https://doi.org/10.1016/j.jvsv.2020.12.078Get rights and content

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: 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: 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.

Section snippets

Study design and setting

A prospective parallel-group randomized controlled trial was conducted both in an authorized thermal center of Abano Terme (Padua, Italy) and at the Vascular Diseases Center of the University of Ferrara (Italy) from October 2019 to February 2020. The protocol was approved by the Institutional Review Board at the University Hospital of Ferrara, and all participants signed informed consent.

Study population

Forty consecutive patients affected by bilateral GSV CVD (C3,Ep,As,Pr) (11M/29F) referred both to the

Characteristics of the study population

Of a total of 40 eligible patients, 6 were excluded (specifics reported in Fig 1) and 34 were recruited and randomized in the study for a total of 68 lower limbs (Fig 1).25 There were no significant differences in demographics between the groups. At baseline, the two groups showed no significant differences in volume, ankle ROM, or GSV caliber between the right and left legs. All participants accomplished the protocol and neither major nor minor adverse events were reported. The detailed

Discussion

To our knowledge, these data are the first to compare the effects of a standardized exercise protocol for patients with CVD in a DL vs TW immersion environment. Water immersion is associated with a significant decrease in leg volume, as shown elsewhere in work focusing on the musculoskeletal system.26, 27, 28

When reporting lower limb volume after physical exercise, a distinction between edema and muscle mass should be made. This point is particularly evident in case of high-intensity exercise

Conclusions

In summary, thermal aquatic exercise provides clinical benefits in terms of edema control, ankle ROM, and disease-specific QoL compared with the same physical activity on DL in patients with CVD class C3 disease.

Author contributions

Conception and design: EM, SG

Analysis and interpretation: EM, SM, PZ, GA, SG

Data collection: EM, PZ, GA, TM, AP, SG

Writing the article: EM, SG

Critical revision of the article: EM, SM, PZ, GA, TM, AP, SG

Final approval of the article: EM, SM, PZ, GA, TM, AP, SG

Statistical analysis: EM

Obtained funding: SM, SG

Overall responsibility: SG

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    The investigation was supported by an unrestricted grant of the “Foundation for Thermal Scientific Research - FORST” (Rome, Italy).

    Author conflict of interest: none.

    Additional material for this article may be found online at www.jvsvenous.org.

    The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.

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