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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03982056
Other study ID # TBA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 30, 2020

Study information

Verified date June 2019
Source University of Portsmouth
Contact Heather Massey, PhD
Phone 07891432744
Email heather.massey@port.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 178
Est. completion date December 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
this is an observational study there are no interventions
development of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics

Locations

Country Name City State
United Kingdom Heather Massey Portsmouth Hampshire

Sponsors (1)

Lead Sponsor Collaborator
University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Floating index Describes the actions required to stay afloat 2 minutes
Secondary Standing Height Height of participant with the two week study window
Secondary Mass Mass of participant with the two week study window - performed at the same time of day as the floating and DEXA scan measurements
Secondary Body composition 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
Secondary Lung function 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
Secondary Buoyancy 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
Secondary Floating technique The technique required to float 2 minutes
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