Floating TechniqueNCT03982056
Float First: An Index of Floating: Factors Affecting Floating in Different Populations
An observational study of Floating Technique and Anthropometry, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Floating Technique, Anthropometry, Lung Function
- How many people
- 178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 30 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ant Shepherd, PhD contact
United Kingdom1 site
Heather Massey
Portsmouth, Hampshire, PO1 2ER
Heather Massey, 02392 843545, heather.massey@port.ac.uk
heather.massey@port.ac.uk
About this study
Official title: "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
Read the 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.
- Conditions
- Floating Technique, Anthropometry, Lung Function
- Being tested
- this is an observational study there are no interventions
- Keywords
- Floating, Sculling, water safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this is an observational study there are no interventionsOther
development of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Assessments performed:
* Height
* Mass
* Body fat density
* Bone density
* Lean muscle density
* Lung volume measurements
* Floating technique
* Buoyancy Receives: Other: this is an observational study there are no interventions | |
| Validation group | Assessments performed:
* Height
* Mass
* Body fat density
* Bone density
* Lean muscle density
* Lung volume measurements
* Floating technique
* Buoyancy Receives: Other: this is an observational study there are no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Floating index
Describes the actions required to stay afloat
Measured: 2 minutes
Secondary outcomes (6)
Standing Height
Height of participant
Measured: with the two week study window
Mass
Mass of participant
Measured: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
Body composition
a break down of the main components of the body (fat, lean tissue)
Measured: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
Lung function
the volumes of the lungs namely, FVC, Tidal breathing, ERV and IRV
Measured: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
Buoyancy
the buoyancy of the person floating in the water
Measured: with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
Floating technique
The technique required to float
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Floating TechniqueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Massey, University of Portsmouth
- Investigators
- Heather Massey, PhD, Principal investigator, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982056
- Sponsor's protocol ID
- TBA
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Float First": Categorising Factors Effecting Floating in Different Populations During Water Immersion.
- ClinicalTrials.gov ID
- NCT03982056
- Acronym / sponsor ID
- TBA
- Conditions
- Floating Technique, Anthropometry, Lung Function
- Keywords
- Floating, Sculling, water safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 11 Jun 2019 (actual)
- 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main study group | – | Other: this is an observational study there are no interventionsAssessments performed: * Height * Mass * Body fat density * Bone density * Lean muscle density * Lung volume measurements * Floating technique * Buoyancy |
| Validation group | – | Other: this is an observational study there are no interventionsAssessments performed: * Height * Mass * Body fat density * Bone density * Lean muscle density * Lung volume measurements * Floating technique * Buoyancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| this is an observational study there are no interventionsdevelopment of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics | Other | Main study group, Validation group |
Primary outcome
Floating index
Time frame: 2 minutes
Describes the actions required to stay afloat
6 secondary outcomes
Standing Height
Time frame: 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
Body composition
Time frame: 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
Buoyancy
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No. 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.
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Aorto-ostial Coronary Lesions, Coronary Angioplasty
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.
Ant Shepherd, PhD contact
Heather Massey, PhD principal investigator
University of Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Floating Technique and Anthropometry, run by University of Portsmouth at 1 site in United Kingdom.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jun 2019. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Massey, PhD (07891432744, heather.massey@port.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Floating index (time frame: 2 minutes). 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 13 Jun 2019.