Effects of Various Modalities Water Immersion on Veins

October 25, 2016 updated by: Laurent Mourot, University of Franche-Comté

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Beliard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Free healthy voluntary

Exclusion Criteria:

  • hypersensitivity to cold

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cold water immersion
Participants immersed their lower limbs in water of ~12°C
Other: immersion
Experimental: contrast water therapy
Participants immersed their lower limbs in water : alternated every 2 min between ~12°C and ~35°C for CWT
Other: immersion
Experimental: thermo neutral immersion
Participants immersed their lower limbs in water of ~35°C
Other: immersion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in common femoral vein cross-section (mm2) during three immersion modalities immersion
Time Frame: Change from Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements
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
change in great saphenous vein antero posterior diameter (mm) during three immersion modalities immersion
Time Frame: Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Franche-Comté

Investigators

  • Principal Investigator: Samuel Beliard, MD, University of Franche-Comté

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 10, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H2O

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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