Relative Energy Deficiency in Sport (RED-S) in International and Canadian High Performance Athletes: Prevalence, Health and Performance Implications
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Iron saturation
研究概览
简要总结
Relative Energy Deficiency in Sport (RED-S) characterizes a range of negative health and performance outcomes that result from chronically low energy availability. RED-S concerns high performance junior and senior athletes across Canada and has a prevalence rate of 3-60%. Our ability to assess and diagnose RED-S remains poor. Accordingly, we aim to create the best parameters to diagnose and manage RED-S; along with information of the prevalence and severity across Canada and globally. These outcomes are expected to have a significant positive impact on the health and performance of Canadian athletes in preparation for the Olympic Games in 2022 and beyond.
详细描述
Purpose:
Our aim is to improve our understanding of the prevalence and symptoms of RED-S in international and Canadian athletes and para-athletes, along with developing screening tools and treatment protocols to manage RED-S in order to improve athlete health, availability and performance.
Objectives:
- Assess the prevalence of self-reported RED-S health outcomes in international and Canadian elite female and male athletes and para-athletes as well as recreational athletes (Study A);
- Assess the prevalence and severity of measured standard/basic RED-S health outcomes including biomarkers and potential longitudinal (6-mo) tracking of outcomes across the Canadian Olympic and Paralympic Sport Institute Network (COPSI) (Study B);
- Implement a more advanced assessment, using novel RED-S assessment parameters in a smaller cohort of key athletes, including potential longitudinal tracking over a 6-mo period (Study C);
- Assess longitudinal changes and the treatment of RED-S symptoms across a 6-month follow-up period in a small cohort of elite Canadian athletes willing to partake in an 'holistic' RED-S treatment intervention arm (Study D);
- Utilize the data created from Studies A,B,C,and D to develop and validate potentially novel RED-S assessment parameters in order to further validate the 'new' IOC RED-S clinical assessment tool (CAT) version 2 to aid in the diagnosis of RED-S.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •International or Canadian elite (National Sport Organization identified) and (Provincial Sport Organization / University varsity identified) Next Generation, or recreational athlete or para-athlete
- •Female or male athlete or para-athlete currently and actively training for and racing in an Olympic sports event
- •Age >15 years
排除标准
- •Under 15 years old
研究组 & 干预措施
Global screening of high-performance athletes for REDS
This arm collects data with an online survey to assess prevalence and signs and symptoms of REDS in elite female and male elite and recreational athletes and para-athletes over the age of 15 years across the world.
Basic screening of Canadian high-performance athletes for REDS
In this study arm, varsity level to elite Canadian athletes and para-athletes will complete a baseline blood sample and potentially (where abnormalities are present) a follow-up 6 months later.
Advanced screening of Canadian high-performance athletes for REDS
In this study arm, varsity level to elite Canadian athletes and para-athletes will complete a baseline test for bone density (DXA scans), resting metabolic rate and exercise testing. Potentially (where abnormalities are present) a follow-up 6 months later.
Treatment of Canadian athletes with REDS: a holistic intervention arm
In this arm, varsity level to elite Canadian athletes and para-athletes with REDS will participate in a nutritional intervention aiming to improve energy availability and thus, REDS status.
干预措施: Treatment of REDS using a holistic treatment arm (Behavioral)
结局指标
主要结局
Iron saturation
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Sex-hormone binding globulin concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Total iron binding capacity
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Triiodothyronine concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Estrogen concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Luteinizing hormone concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Follicle-stimulating hormone concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Serum iron concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
HDL cholesterol concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
REDS clinical assessment tool and REDS risk score
时间窗: Baseline and possibly change after 6 months for a subset of athletes
a combination of validated and semi-validated questionnaires
Menstrual function in females
时间窗: Baseline and possibly change after 6 months for a subset of athletes
via Low Energy Availability in Females Questionnaire (higher scores reflect higher risk of RED-S) and use of urinary ovulation strips to measure LH surge
Hemoglobin concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Ferritin concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
LDL cholesterol concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Triglycerides concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Strength
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Maximal strength tests
Testosterone concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Resting heart rate
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Heart rate monitor (Polar electro)
Insulin like growth factor 1 concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Total cholesterol concentrations
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Bone mineral density
时间窗: Baseline
Dual energy x ray scan of lumbar spine and femoral neck bone density
Blood pressure (systolic and diastolic)
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Blood pressure monitor
Resting metabolic rate
时间窗: Baseline and possibly change after 6 months for a subset of athletes
Assessment done with a metabolic cart by collecting respiratory gases
Aerobic capacity
时间窗: Baseline and possibly change after 6 months for a subset of athletes
maximal oxygen uptake test
Bone stress injury history
时间窗: Baseline and possibly change after 6 months for a subset of athletes
online questionnaire on type and number of injuries
次要结局
- Body composition(Baseline and possibly change after 6 months for a subset of athletes)
- Insulin concentrations(Baseline and possibly change after 6 months for a subset of athletes)
- illness history(Baseline and possibly change after 6 months for a subset of athletes)
- Prolactin concentrations(Baseline and possibly change after 6 months for a subset of athletes)
- Cardiac health(Baseline and possibly change after 6 months for a subset of athletes)
- Eating disorder assessment(Baseline and possibly change after 6 months for a subset of athletes)
- History of weight change(Baseline and possibly change after 6 months for a subset of athletes)
- Complete blood count(Baseline and possibly change after 6 months for a subset of athletes)
- Glucose concentrations(Baseline and possibly change after 6 months for a subset of athletes)
- Cortisol concentrations(Baseline and possibly change after 6 months for a subset of athletes)
- 25(OH)D concentrations(Baseline and possibly change after 6 months for a subset of athletes)
- Male athlete health(Baseline and possibly change after 6 months for a subset of athletes)
- Sleep hygiene(Baseline and possibly change after 6 months for a subset of athletes)
- Mental health(Baseline and possibly change after 6 months for a subset of athletes)
- Mood state(Baseline and possibly change after 6 months for a subset of athletes)
- REDS treatment arm(Individualised but likely 3-6 months)
- Soft-tissue injury history(Baseline and possibly change after 6 months for a subset of athletes)
- Gut health(Baseline and possibly change after 6 months for a subset of athletes)
- History of anemia(Baseline and possibly change after 6 months for a subset of athletes)
研究者
Trent Stellingwerff
Director of Performance Solutions, Innovation & Research for Canadian Sport Institute Pacific (CSI Pacific) Adjunct Faculty - Exercise Science, Physical & Health Education (EPHE), University of Victoria (UVic)
University of Victoria