NCT02677402

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

January 10, 2016

Last Update Submit

October 25, 2016

Conditions

Hydrotherapy

Keywords

femoral veinsaphenous veinhydrostatic pressuretemperaturerecovery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

cold water immersion

EXPERIMENTAL

Participants immersed their lower limbs in water of \~12°C

Other: immersion

contrast water therapy

EXPERIMENTAL

Participants immersed their lower limbs in water : alternated every 2 min between \~12°C and \~35°C for CWT

Other: immersion

thermo neutral immersion

EXPERIMENTAL

Participants immersed their lower limbs in water of \~35°C

Other: immersion

Interventions

immersionOTHER
cold water immersioncontrast water therapythermo neutral immersion

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free healthy voluntary

You may not qualify if:

  • hypersensitivity to cold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beliard

Besançon, 25000, France

Location

MeSH Terms

Interventions

Immersion

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Samuel Beliard, MD

    University of Franche-Comte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 10, 2016

First Posted

February 9, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)