- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982056
Float First: An Index of Floating: Factors Affecting Floating in Different Populations
June 11, 2019 updated by: Heather Massey, University of Portsmouth
"Float First": Categorising Factors Effecting Floating in Different Populations During Water Immersion.
The study involves measurements of body composition using a DEXA scanner, lung function, buoyancy and floating technique.
An understanding of the effects of physiological and anthropometric measures on an individual's ability to float may lead to the creation of a 'Floatability Score' to aid current public information.
With this floatability score a set of actions that people of certain body types should adopt in water will be created, to tailor the current public safety messaging in an attempt to ensure more people are aware of how they can float in water
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Between 2000 and 2013 an average of 425 people in the UK drowned per annum, and a reported 100,000 people were involved in water-related emergencies involving search and rescue services.
Approximately half had not intended to go into the water.
Research identifies that in the first 1-3 minutes of immersion, during the "cold shock response" (CSR), there may be an increased probability of drowning fatalities.
As a result of this, a theme of 'Float First' was created whereby individuals are advised to float for 1-3 minutes following immersion (by undertaking the minimum amount of activity possible to maximise the amount of air trapped in clothing layers and hence creating additional buoyancy) until the effects of the CSR have declined.
However, a number of people have come forward indicating that despite the advice given, they are unable to float.
This study is designed to establish the minimum activity level a person needs to stay afloat and combine this with anthropomorphic and physiological measures to develop advice for people of different shapes, sizes and body compositions.
Study Type
Observational
Enrollment (Anticipated)
178
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
-
-
Hampshire
-
Portsmouth, Hampshire, United Kingdom, PO1 2ER
- Heather Massey
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Accepting all adults able to give their own consent to participate, the investigators aim to recruit a mixture of participants of different body size, shape, sex and race
Description
Inclusion Criteria:
- All participants who feel confident in water which they can stand up in, aged 18 years and older (18-29 years for Phase 1).
- The participant is willing and able to give informed consent for participation in the study.
- Be able to climb up and down a set of steps to access the swimming flume
Exclusion Criteria:
- Have allergies to water or chlorinated water.
- The participant is pregnant or suspects they may be pregnant.
- Not able to climb up and down a set of steps to access the swimming flume
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Main study group
Assessments performed:
|
development of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics
|
|
Validation group
Assessments performed:
|
development of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Floating index
Time Frame: 2 minutes
|
Describes the actions required to stay afloat
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Standing Height
Time Frame: with the two week study window
|
Height of participant
|
with the two week study window
|
|
Mass
Time Frame: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
Mass of participant
|
with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
|
Body composition
Time Frame: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
a break down of the main components of the body (fat, lean tissue)
|
with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
|
Lung function
Time Frame: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
the volumes of the lungs namely, FVC, Tidal breathing, ERV and IRV
|
with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
|
Buoyancy
Time Frame: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
the buoyancy of the person floating in the water
|
with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
|
|
Floating technique
Time Frame: 2 minutes
|
The technique required to float
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather Massey, PhD, University of Portsmouth
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 (Anticipated)
July 1, 2019
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
June 10, 2019
First Submitted That Met QC Criteria
June 10, 2019
First Posted (Actual)
June 11, 2019
Study Record Updates
Last Update Posted (Actual)
June 13, 2019
Last Update Submitted That Met QC Criteria
June 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TBA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The participant's data will be anonymized and presented to interested parties as part of the groups' data.
There are no plans to share the information which can be identifiable to a particular participant.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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