- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06480682
Relative Energy Deficiency in Sport and Dance
Prevalence of Relative Energy Deficiency in Sport and Dance
Study Overview
Status
Detailed Description
Participants will be asked to be available three times for testing over a 12-month period, for a period of 3-years. Their initial test visit will be at a university exercise science laboratory whilst the other testing sessions will occur at their place of work/training.
Each year the initial testing session will include a bone health scan (DXA), a blood sample (2x 5ml samples), a body composition analysis (bioimpedance), resting metabolic rate test and a series of questionnaires. Subsequent test session will include the same tests except the DXA scan unless there is a medical reason to carry out a further scan (two or more bone stress injuries).
The DXA scan, where participants will need to lie still for approximately 20 minutes will monitor body composition, bone mineral density and bone mineral content for the whole body and at the forearm (radius), lower spine (Lumbar 4 and 5) and upper leg (femur). The scan will also look at the ratio between outer (cortical) and inner (trabecular) bone content.
The blood samples will measure a series of markers that have been associated with low energy availability for male and female participants and amenorrhea for female participants.
Anthropometric measurements will consist of body composition analysis will consist of a body composition, stature and body mass. The participant will have their height measured and then stand on bioimpedance scales and hold onto two handles. This will allow changes in body composition changes to be monitored throughout the year without exposing the participant to further radiation from the DXA.
To monitor resting metabolic rate participants will lie down on a bed in a quiet room. They will be fitted with a mask over the mouth and nose that is connected to a breathe-by-breathe gas analyser. They will lie as still as possible for 20-minutes for the test to conclude.
The validated questionnaires (Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire, Health questionnaire) will focus on sleep quality, general health, attitudes towards food and eating, perceptions of energy availability, and mood.
Basic injury incidence data will be provided by the participant's medical team through out the monitoring period. Injury data will consist of location, type and severity of each injury.
Participants' injury incidence and aetiology will be monitored by their club's/company's medical teams and summarised data provided to the research team via a signed medical release agreement. REDs prevalence will be analysed by the research team in conjunction with the participants' medical teams and for those diagnosed with the syndrome the relevant management plan will be put into place for their safe return to activity.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matthew A Wyon, PhD
- Phone Number: 01902323144
- Email: m.wyon@wlv.ac.uk
Study Contact Backup
- Name: Ross Cloak, PhD
- Phone Number: 01902321285
- Email: r.cloak@wlv.ac.uk
Study Locations
-
-
West Midlands
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Walsall, West Midlands, United Kingdom, WS1 3BD
- University of Wolverhampton
-
Contact:
- Matthew Wyon, PhD
- Phone Number: 01902323144
- Email: m.wyon@wlv.ac.uk
-
Contact:
- Ross Cloak, PhD
- Phone Number: 0190231285
- Email: r.cloak@wlv.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Full-time training at either a NGB centre, dance company, vocational dance school or academy
- Engaged in full-time training at start of project
Exclusion Criteria
- Not engaged in full-time training
- Injury preventing engagement in training
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dance
Age: 16-45yrs old Sex: Female and male Activity: Dance (ballet, contemporary, musical theatre); Level: Full-time training at either a dance company, vocational dance school Status: Engaged in full-time training at start of project without activity limiting injury
|
Annual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition
Three times a year blood samples will be taken to measure: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin
Informed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females)
Other Names:
Three times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence)
Resting metabolic rate will be measured by resting gas analysis.
Each participant will lie down for a period of 15 minutes, in the final 5 minutes their expired gases are analysed using a breath-by-breath gas analyser (Cortex).
|
|
Combat Sports
Age: 16-45yrs old Sex: Female and male Activity: Combat sports (judo, karaté, taekwondo); Level: Full-time training at either a NGB centre Status: Engaged in full-time training at start of project without activity limiting injury
|
Annual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition
Three times a year blood samples will be taken to measure: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin
Informed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females)
Other Names:
Three times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence)
Resting metabolic rate will be measured by resting gas analysis.
Each participant will lie down for a period of 15 minutes, in the final 5 minutes their expired gases are analysed using a breath-by-breath gas analyser (Cortex).
Energy expenditure was estimated using accelerometery (Genieactive) and activity logs in the participants' normal environment, assessed during 3 weekdays of scheduled dance training and 2 weekend days without scheduled dance training.
Focus is on daily energy expenditure
|
|
Gymnastics
Age: 16-45yrs old Sex: Female and male Activity: Gymnastics (artistic) Level: Full-time training at either a NGB centre or academy Status: Engaged in full-time training at start of project without activity limiting injury
|
Annual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition
Three times a year blood samples will be taken to measure: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin
Informed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females)
Other Names:
Three times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence)
Resting metabolic rate will be measured by resting gas analysis.
Each participant will lie down for a period of 15 minutes, in the final 5 minutes their expired gases are analysed using a breath-by-breath gas analyser (Cortex).
Energy expenditure was estimated using accelerometery (Genieactive) and activity logs in the participants' normal environment, assessed during 3 weekdays of scheduled dance training and 2 weekend days without scheduled dance training.
Focus is on daily energy expenditure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative energy deficiency (REDs)
Time Frame: Throughout study; an average of 3 times a year
|
Prevalence of REDs in cohorts by diagnosis by elimination by medical team.
|
Throughout study; an average of 3 times a year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone stress injuries
Time Frame: Number of participants with bone stress injuries. Throughout study an average of 3 times a year
|
Reported bone stress injuries by the inhouse medical teams
|
Number of participants with bone stress injuries. Throughout study an average of 3 times a year
|
|
Primary Amenorrhea (females)
Time Frame: Number of participants with primary and secondary amenorrhea. Throughout study an average of 3 times a year
|
Loss of menses for at least 6 months
|
Number of participants with primary and secondary amenorrhea. Throughout study an average of 3 times a year
|
|
Resting Metabolic rate
Time Frame: Throughout study; an average of 3 times a year
|
Actual resting metabolic rate/estimated metabolic rate below 0.9
|
Throughout study; an average of 3 times a year
|
|
Monitoring of all blood markers for below normal values (red flags)
Time Frame: Throughout study; an average of 3 times a year
|
Blood markers: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin
|
Throughout study; an average of 3 times a year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Roger Wolman, PhD, Honorary Professor
Publications and helpful links
General Publications
- Koltun KJ, Strock NCA, Southmayd EA, Oneglia AP, Williams NI, De Souza MJ. Comparison of Female Athlete Triad Coalition and RED-S risk assessment tools. J Sports Sci. 2019 Nov;37(21):2433-2442. doi: 10.1080/02640414.2019.1640551. Epub 2019 Jul 11.
- Sim A, Burns SF. Review: questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. J Eat Disord. 2021 Mar 31;9(1):41. doi: 10.1186/s40337-021-00396-7.
- Allen N, Kelly S, Lanfear M, Reynolds A, Clarke R, Mountjoy ML, Wyon M, Wolman R. Relative energy deficiency in dance (RED-D): a consensus method approach to REDs in dance. BMJ Open Sport Exerc Med. 2024 Mar 7;10(1):e001858. doi: 10.1136/bmjsem-2023-001858. eCollection 2024.
- Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994. Erratum In: Br J Sports Med. 2024 Feb 7;58(3):e4. doi: 10.1136/bjsports-2023-106994corr1.
- Civil R, Lamb A, Loosmore D, Ross L, Livingstone K, Strachan F, Dick JR, Stevenson EJ, Brown MA, Witard OC. Assessment of Dietary Intake, Energy Status, and Factors Associated With RED-S in Vocational Female Ballet Students. Front Nutr. 2019 Jan 9;5:136. doi: 10.3389/fnut.2018.00136. eCollection 2018.
- Staal S, Sjodin A, Fahrenholtz I, Bonnesen K, Melin AK. Low RMRratio as a Surrogate Marker for Energy Deficiency, the Choice of Predictive Equation Vital for Correctly Identifying Male and Female Ballet Dancers at Risk. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):412-418. doi: 10.1123/ijsnem.2017-0327. Epub 2018 Jun 22.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REDsWyon24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Study Data/Documents
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Individual Participant Data Set
Information identifier: RED-DInformation comments: All anonymised data will be published on figshare
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Study Protocol
Information identifier: RED-DInformation comments: Study protocol will be published on figshare
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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