Condition category
Not Applicable
Date applied
04/12/2011
Date assigned
16/01/2012
Last edited
29/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
To investigate the immediate and short term effects on health for runners who collapse during Marathons. Marathon runners may collapse for a variety of reasons, including loss of muscle tone at the end of exercise (exercise associated collapse), imbalances in the levels of salts in the blood, and exertional heat stroke (EHS). EHS is a life-threatening illness with a very high core body temperature, above 40 degree celsius, associated with abnormal brain function. Up to 10% of runners with EHS may die. Marathon runners may also experience a variety of symptoms, including confusion, memory and balance problems, for weeks after a marathon.
If a runner experiences EHS, the temperature should be reduced to normal as soon as possible. The progression of the disease is primarily related to the initial care provided to the casualty. Medical teams at the event itself are therefore recommended to immediately identify and treat these serious conditions to reduce the complications from the collapse. Basic blood test results should be immediately available to the clinical team. For every 10,000 marathon runners, approximately 20 collapses will require intensive road-side assessment, monitoring and treatment by these teams. The majority of these cases will be able to be discharged home direct from the event, without the need for hospital treatment. If this medical service were unavailable at Marathons, then the local Emergency Department (ED) services would be required to treat these patients. The delay in treatment may cause additional complications. In the USA, patients with EHS are often admitted to hospital for 72 hours.
The medical team at the Brighton Marathon provides immediate treatment, invasive monitoring and point of care blood tests for all collapsed runners. If after a period of treatment and observation the medical team feels that the patient is safe to be discharged home, without the need for hospital admission, discharge advice and instructions are given. Collapsed runners are advised to see their general parctitioner (GP) within 48-72hrs for a test of their urine, and to repeat blood tests. This is to ensure that they haven't developed short term kidney complications.
The aim of this study is to obtain blood results taken on the day and at follow-up as part of good practice. In addition we would ask the runner if they would be willing to complete a questionnaire to investigate any immediate and short-term physical, neurological and psychological effects following collapse during a marathon.

Who can participate?
Both male and female runners old enough to participate in the marathon who collapse at the 2012, 2013 and 2014 Brighton marathon and require treatment by the on-site medical team and willing to participate in the study

What does the study involve?
The study will not change the participants treatment, but will ask if participants will give permission to the research team to check the records and analyse clinical information and investigations performed by the medical team at the marathon and by their GPs after the marathon. In addition the runner will be asked to fill in a short questionnaire asking questions about their health in the first week following the marathon and again at 3 months following the marathon.

What are the possible benefits and risks of participating?
Participants are unlikely to benefit directly from the study, but the information obtained will be used to gain more understanding about runners who collapse, and may improve treatment for runners in future marathons. The same medical treatment and follow-up care will be provided whether runners are in the study or not. No extra blood tests are needed for the study. Runners in the study will only be required to complete 2 short questionnaires, which should not be hard for the runners. The results of the blood tests and the questionnaires will be anonymised.

Where is the study run from?
Worthing Hospital (UK).

When is the study starting and how long is it expected to run for?
The study ran over the 2012, 2013 and 2014 marathons.

Who is funding the study?
We expect the study to have minimal costs, which will be met by the research team and by Brighton Marathon.

Who is the main contact?
Helen Evans, Research Governance Manager
helen.evans@wsht.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Venn

ORCID ID

Contact details

Western Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.0

Study information

Scientific title

Effects on health following collapse during marathon running: a prospective observational study

Acronym

Study hypothesis

Marathon runners who collapse during the marathon may experience physical and neuro-cognitive symptoms which may persist for several months. Little is known about these or the biochemical changes seen following a collapse.

On 28/07/2015 the overall trial end date was changed from 30/07/2012 to 30/07/2014.

Ethics approval

NRES Committee South Central - Portsmouth, 21/01/2013, REC ref: 12/SC/0048

Study design

Observational prospective study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Collapsed marathon runners

Intervention

The runner will be asked to fill in a short questionnaire asking questions about their health in the first week following the marathon and again at 3 months following the marathon.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Descriptive statistics to describe:
1. Demographics of runners who collapsed at the marathon including relevant marathon- training history, fluid & dietary management, comorbidities & medication history
2. Diagnosis and management required by the Intensive Care medical service at the marathon
3. Biochemical changes at the marathon & follow up
4. Health questionnaires at approximately 1 week & 3 months following the marathon
5. Any medical intervention at follow up required

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/04/2012

Overall trial end date

30/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 28/07/2015:
Runners who collapse at the 2012, 2013 and 2014 Brighton marathons and require treatment by the on-site medical team

Previous inclusion criteria:
Runners who collapse at the 2012 Brighton marathon and require treatment by the on-site medical team

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/04/2012

Recruitment end date

15/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Western Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom

Sponsor information

Organisation

Sussex NHS Research Consortium (UK)

Sponsor details

c/o Helen Evans
Research Governance Manager
Sussex NHS Research Consortium
Worthing
BN11 2DH
United Kingdom

Sponsor type

Government

Website

http://www.westernsussexhospitals.nhs.uk/about-us/worthing-hospital/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We have written up and submitted for publication. The write-up contains aims, protocol, methods, and discussion on the biochemical changes, and reported symptoms.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes