Journal of Vascular Surgery: Venous and Lymphatic Disorders
Clinical research studyExercise therapyRandomized controlled trial on Dryland And Thermal Aquatic standardized exercise protocol for chronic venous disease (DATA study)
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
References (40)
- et al.
The epidemiology of chronic venous insufficiency and varicose veins
Ann Epidemiol
(2005) - et al.
Quality of life in patients with chronic venous disease: San Diego population study
J Vasc Surg
(2003) - et al.
The burden of depression in patients with symptomatic varicose veins
Eur J Vasc Endovasc Surg
(2012) - et al.
Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trial
J Vasc Surg
(2004) - et al.
International psychometric validation of the Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Eur J Vasc Endovasc Surg
(2010) - et al.
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials
Int J Surg
(2012) - et al.
Underwater Sonography of Leg Veins
EJVES Short Rep
(2018) - et al.
An overview of the most commonly used venous quality of life and clinical outcome measurements
J Vasc Surg Venous Lymphat Disord
(2015) - et al.
Chronic venous disease: health status of a population and care impact on this health status through quality of life questionnaires
Int Angiol
(2005) - et al.
Socio-economic impact of chronic venous insufficiency. An underestimated public health problem
Int Angiol
(1998)
Evaluating the expected costs and budget impact of interventional therapies for the treatment of chronic venous disease
Am Health Drug Benefits
Chronic venous disease
N Engl J Med
Graduated compression stockings
CMAJ
The properties of water and their applications for training
J Hum Kinet
Sulphate mineral waters: a medical resource in several disorders
J Tradit Complement Med
Patient education and rehabilitation after hip arthroplasty in an Italian spa center: a pilot study on its feasibility
Int J Biometeorol
The role of thermal balneotherapy in the treatment of obese patient with knee osteoarthritis
Int J Biometeorol
Scientific evidence-based effects of hydrotherapy on various systems of the body
N Am J Med Sci
Reversal of lower limb edema by calf muscle pump stimulation
J Cardiopulm Rehabil Prev
Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study
Arch Surg
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2022, European Journal of Vascular and Endovascular SurgeryCitation Excerpt :The Law of Laplace becomes irrelevant permitting high pressures to be achieved without discomfort or any tension induced skin stress over fulcrum points.74 Compression by water has been shown to be effective in improving venous haemodynamics,100,101 and reducing leg volumetry in people with leg oedema.102,103 Although this type of compression is ideal in theory, current prototypes are experimental and subject of ongoing research.
Reply
2021, Journal of Vascular Surgery: Venous and Lymphatic Disorders
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.