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
- 2
- 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
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