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临床试验/NCT03934411
NCT03934411已完成不适用

Effect of Increased Pain Tolerance on Exercise Performance

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Power output

研究概览

简要总结

Clinical prescription and use of opioids is a clear problem in large parts of the world and has the recent years received an increasing publicity in sports. This is in particular due to the World Anti-Doping Agency monitoring list, which reveal that endurance athletes utilize the opioid Tramadol frequently with the aim to enhance performance according to anecdotal evidence.

Studies investigating the effect of tramadol on exercise performance in healthy humans is limited to one study in moderate trained subjects. However, this effect may be different in highly trained subjects due to the effects of chronic exercise. Furthermore, ingestion of tramadol may impact motor-cognitive performance and it remains unknown whether tramadol can be detected in highly trained subjects following exercise.

In the present study the investigators apply a randomized double-blind placebo-controlled counterbalanced cross-over design to investigate whether tramadol treatment improves a preloaded cycling time trial performance, whether it affects motor-cognitive performance and whether it is detectable following exercise.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Maximal oxygen uptake < 55 ml O2/min/kg
  • Plasma creatinine concentration between 60-105 umol/L
  • Plasma alanine aminotransferase between 10-70 U/L
  • Familiarized with endurance training for at least a few years

排除标准

  • Donated blood within the last 3 months
  • Exposed to an altitude greater than 1000 m above sea level within the last two months

研究组 & 干预措施

Tramadol treatment

Experimental

干预措施: Tramadol (Drug)

Placebo treatment

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Power output

时间窗: 30 minutes

Mean power output during a 15-km time trial

Motor-cognitive performance

时间窗: 1 hour

The motor-cognitive performance evaluated by mathematical calculations combined with the ability to pinch a certain force with the thumb and index finger

Detection rate

时间窗: 1 day

The detection rate of tramadol following the exercise intervention measured before, immediately after as well as 6 and 24h after treatment

次要结局

  • pH(90 min)
  • Lactate(90 min)
  • Bicarbonate(90 min)
  • Glucose(90 min)
  • Potassium(90 min)
  • Sodium(90 min)
  • Oxygen uptake(90 min)
  • Pulmonary ventilation(90 min)
  • Respiratory exchange ratio(90 min)
  • Rate of Perceived Exertion(90 min)
  • Leg Pain(90 min)
  • Heart rate(90 min)
  • Power output during preload(60 min)
  • Power output during time trial(30 min)

研究者

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

Nikolai Nordsborg

Associate Professor

University of Copenhagen

研究点 (1)

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