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临床试验/NCT04005027
NCT04005027暂停不适用

Exercise Induced Inter-individual Responses in QT Interval Duration and Dispersion During and Following Intermittent and Continuous Graded Exercise Tests in Young Male Football Players

University of Sunderland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
50
试验地点
1
主要终点
QT interval duration

研究概览

简要总结

Long QT syndrome (LQTS) is an inherited heart defect where the heart takes longer to recover between beats. LQTS is a known condition predisposing young footballers to sudden cardiac death (SDC). The existence of LQTS can be established by measuring the QT interval in an electrocardiogram (ECG). Currently pre-participation cardiac screening is performed in young athletes but players may only be screened at 16 years old using only a resting ECG, and a medical check including a questionnaire on family and medical history. However, the sensitivity and specificity of the screening to investigate underlying causes of SCD could be improved with the addition of an exercise stress test or cardiopulmonary exercise test (CPET). Certain abnormalities in the heart may only become apparent when the heart has been stressed (e.g. via exercise). This is particularly important as in young athletes these abnormal rhythms manifest during rest and recovery rather than at peak exercise. The CPET measures changes in the ECG in response to exercise that increases in intensity in a continuous manner until the participant cannot exercise any long. However, football is characterised by high- intensity bouts of exercise interspersed with low-intensity bouts or pauses. Therefore, the continuous test does not reflect the movement patterns of football and may not stress the cardiovascular system in a similar manner. To address this, intermittent graded exercise tests have been developed to reflect the intermittent movement pattern. As yet there is limited evidence on whether there are any differences in ECG changes during intermittent exercise. Specifically, it is not clear how an intermittent movement pattern might affect the QT interval.

详细描述

Long QT syndrome (LQTS) is an ion channelopathy which occurs in approximately 1 in every 2500 individuals. Symptoms include; syncope, seizures and sudden cardiac death (SCD). LQTS's genetic defects culminate in delayed cardiac repolarization identified on a 12 lead electrocardiogram (ECG) as a prolonged QT interval. Due to the dynamic nature of channelopathies, some abnormalities could be missed with a resting ECG alone. In young athletes cardiac arrhythmia's predisposing athletes to SCD do not usually occur at peak exercise but during warm-up, recovery or periods of reduced exercise intensity (e.g. rest phases in football games). Environments causing increase in body temperature, heat rate, and autonomic status should therefore be included in the assessment of risk of SCD. Whilst the use of cardiopulmonary exercise testing (CPET) is commonplace, the use of such an exercise test is often performed using a continuous ramp or step procedure (e.g Bruce protocol). However, during games play such as football, movements are not continuous but intermittent characterised by rest phases and lower intensity periods of exercise. The primary aim of this study is to assess the duration and dispersion of the QT interval during and immediately following the performance of a continuous (CONT), and an intermittent (INT) maximal graded exercise test in a group of young (< 16-18 yr) semi-professional soccer players. It is anticipated that the INT graded exercise test will induce greater inter-individual variability in the QT interval compared to the CONT trial.

The investigators aim to recruit approximately 50 players from Sunderland Foundation of Light regional training centre (RTC) with a minimum sample size of 24. We will use a replicated randomised repeated measures crossover design in which the participants will be randomised to different sequences of four experimental conditions; two continuous graded exercise tests, and two intermittent graded exercise tests, randomised using a Latin square counterbalanced design. Participants will be required to perform all four exercise conditions at approximately the same time of day (± 1 h) to control for within-athlete variation. Each exercise condition will be separated by at least 72 h with all testing sessions complete within a 2-4 week period. The following constraints will be placed on the participants to improve the strength of the study design:

  • Avoid strenuous physical activity for 48-72 h prior to testing.
  • Avoid caffeine consumption for 4 h prior to testing and alcohol at least 12 h.
  • Maintain normal hydration by drinking to thirst prior to testing.
  • Consume a high carbohydrate meal 2 h prior to testing.

Exercise testing

Exercise will be performed in a temperature controlled physiology laboratory. Participants will perform two graded exercise tests, repeated twice. The continuous graded exercise test (CONT) will increase treadmill speed incrementally using three minute stage duration on a motorised treadmill. The initial speed will be individualised designed to evoke a heart rate around 40-50% of one's age predicted maximal heart rate using 206.9 - (0.67* age [yrs]). This will be gauged from a 3 minute low intensity warm-up at the start. The speed will increase by 1 km.hr-1 every three minutes until volitional exhaustion. The gradient of the treadmill will be set at 1 % to reflect energy expenditure of over-ground running. Gradient will only be increased if the performer reaches the limits of their stride frequency and length and therefore it would be inappropriate to continue to increase speed of the belt. The intermittent graded exercise test (INT) will follow the same procedure. However, the speed within each three minute exercise bout will vary every 30 s between the target speed, and a complete pause for 30 s. The acceleration of the treadmill belt will be set to its maximum capability. Participants will be familiarised with this acceleration to ensure safety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
16 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy male soccer players
  • •Must be participating in ~3 - 6 h of soccer training per week as part of a soccer academy or regional training centre (RTC)

排除标准

  • •More than one coronary artery disease risk factor
  • •At least one cardiovascular, respiratory or metabolic disease.
  • •Have suffered from a lower limb musculoskeletal injury in the past 6 months

研究组 & 干预措施

Intermittent graded exercise (INT)

Experimental

The intermittent graded exercise test (INT) increase treadmill speed incrementally using three minute stage duration on a motorised treadmill. However, the speed within each three minute exercise bout will vary every 30 s between the target speed, and a complete pause for 30 s. The acceleration of the treadmill belt will be set to its maximum capability.

干预措施: Intermittent graded exercise test (Other)

Continuous graded exercise (CONT)

Active Comparator

The continuous graded exercise test (CONT) will increase treadmill speed incrementally using three minute stage duration on a motorised treadmill

干预措施: Intermittent graded exercise test (Other)

结局指标

主要结局

QT interval duration

时间窗: Measured during exercise, and immediately following exercise (6 min recovery)

Duration of the QT interval calculated in each 3 minute stage using various algorithms

次要结局

  • Ventilatory threshold(During exercise determined using V slope method (10 second, and middle 5 of 7 averages))
  • Maximal/ Peak Oxygen Uptake(End of exercise (final workload stage) taken as highest value over 30 second average)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Will Evans

Principle Investigator

University of Sunderland

研究点 (1)

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