HydrotherapyNCT02677402
Effects of Various Modalities Water Immersion on Veins
A study testing immersion in people with Hydrotherapy, run by University of Franche-Comté at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hydrotherapy
- What is being tested?
- immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free healthy voluntary
Who cannot join
- hypersensitivity to cold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hydrotherapy
- Being tested
- immersion
- Keywords
- femoral vein, saphenous vein, hydrostatic pressure, temperature, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersionOther
| Study group | Role | What they receive |
|---|---|---|
| cold water immersion | Experimental | Participants immersed their lower limbs in water of ~12°C Receives: 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 Receives: Other: immersion |
| thermo neutral immersion | Experimental | Participants immersed their lower limbs in water of ~35°C Receives: Other: immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Franche-Comté
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Mourot, University of Franche-Comté
- Investigators
- Samuel Beliard, MD, Principal investigator, University of Franche-Comte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677402
- Sponsor's protocol ID
- H2O
- Status last verified
- Oct 2016
- First submitted
- 10 Jan 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres
- ClinicalTrials.gov ID
- NCT02677402
- Acronym / sponsor ID
- H2O
- Conditions
- Hydrotherapy
- Keywords
- femoral vein, saphenous vein, hydrostatic pressure, temperature, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Franche-ComtéUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cold water immersion | Experimental | Other: immersionParticipants immersed their lower limbs in water of ~12°C |
| contrast water therapy | Experimental | Other: immersionParticipants immersed their lower limbs in water : alternated every 2 min between ~12°C and ~35°C for CWT |
| thermo neutral immersion | Experimental | Other: immersionParticipants immersed their lower limbs in water of ~35°C |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Free healthy voluntary
Key exclusion criteria (1 listed)
- hypersensitivity to cold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immersion | Other | cold water immersion, contrast water therapy, thermo neutral immersion |
Primary outcome
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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Beliard, MD principal investigator
University of Franche-Comte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immersion in people with Hydrotherapy, run by University of Franche-Comté at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.