Effects of Various Modalities Water Immersion on Veins

Hydrotherapy Clinical Trial

Official title:

Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677402
• Other study ID #: H2O
• Status: Completed
• Phase: N/A
• First received: January 10, 2016
• Last updated: October 25, 2016
• Start date: December 2012

Study information

• Verified date: October 2016
• Source: University of Franche-Comté
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT).

Design Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI (~35°C), CWI (~12°C) or CWT (2:2minutes (~12°C to ~35°C) ratio), selected randomly.

Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Free healthy voluntary

Exclusion Criteria:

• hypersensitivity to cold

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hydrotherapy

Intervention

Other:
• immersion

Locations

Country	Name	City	State
France	Beliard	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
University of Franche-Comté

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in common femoral vein cross-section (mm2) during three immersion modalities immersion	thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT)	Change from Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements	Yes
Primary	change in great saphenous vein antero posterior diameter (mm) during three immersion modalities immersion	thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT)	Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements	Yes