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NCT Number: NCT06480682

Relative Energy Deficiency in Sport and Dance

The International Olympic Committee recently published its consensus statement on relative energy deficiency syndrome (REDs) in sport which was followed by a similar version for dance by clinicians and researchers in dance. REDs is a complex multisystem syndrome with low energy availability as its foundation. Dancers and gymnasts, particularly in ballet, have long been reported to have body weight issues with an increase prevalence of eating disorders which has been associated with early onset osteoporosis. Combat sports have a similar issue, with athletes needing to "make weight" to compete in their ideal weight category that has lead to similar eating disorder and associated issues to dance. Currently there are no data on REDs prevalence in dance, gymnastics or combat sports and therefore understanding the underlying prevalence of REDs in both these populations will provide important information for both clinicians and coaches to help develop a safe and healthy environment for their dancers and athletes to compete/perform and to be able to retire from sport/dance without an increased risk of osteoporosis. In a few sports and dance genres, some participants might be more prone to a negative health effect referred to as relative energy deficiency syndrome (REDs). This is an energy deficiency relative to the balance between dietary energy intake and energy availability required to support homeostasis, health and activities of daily living, growth and sporting activities that can result in multiple systems being affected including decreases in bone health, energy metabolism, reproductive function, musculoskeletal health, immunity, glycogen synthesis and cardiovascular and haematological health. The purpose of this study is to examine the prevalence of REDs in specific sports (combat sports and gymnastics) and dance genres (ballet and musical theatre). Voluntary participants will be tested three times a year over a 5-year period. This will include an annual dual-energy x-ray absorptiometry and blood tests plus resting energy expenditure and questionnaires three times a year.

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Key information

Conditions

Relative Energy Deficiency in Sport Bone Stress Reaction Feeding and Eating Disorders Fractures, Bone Fractures, Stress Mental Disorders Wounds and Injuries

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual x-ray scan

Radiation

Annual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition

Blood screen

Diagnostic Test

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

questionnaires

Other

Informed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females)

Other names: Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire; Consent; Health

Anthropometric measurements

Other

Three times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence)

Resting Metabolic rate

Procedure

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Resting Metabolic rate

    Time frame: Throughout study; an average of 3 times a year

    Actual resting metabolic rate/estimated metabolic rate below 0.9

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew A Wyon, PhD

CONTACT

[email protected]

01902323144

Ross Cloak, PhD

CONTACT

[email protected]

01902321285

Sponsors and collaborators

Lead sponsor

University of Wolverhampton

Other

Registry information

Official study title

Prevalence of Relative Energy Deficiency in Sport and Dance

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 28, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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