Clinical trial NCT03934411: Effect of Increased Pain Tolerance on Exercise Performance
Official title: Effect of Increased Pain Tolerance on Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Exercise
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Anti Doping Danmark
name: Oslo University Hospital
First posted: 2019-05-01
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Power output
timeFrame: 30 minutes
measure: Motor-cognitive performance
timeFrame: 1 hour
measure: Detection rate
timeFrame: 1 day
Secondary outcomes:
measure: pH
timeFrame: 90 min
measure: Lactate
timeFrame: 90 min
measure: Bicarbonate
timeFrame: 90 min
measure: Glucose
timeFrame: 90 min
measure: Potassium
timeFrame: 90 min
measure: Sodium
timeFrame: 90 min
measure: Oxygen uptake
timeFrame: 90 min
measure: Pulmonary ventilation
timeFrame: 90 min
measure: Respiratory exchange ratio
timeFrame: 90 min
measure: Rate of Perceived Exertion
timeFrame: 90 min
measure: Leg Pain
timeFrame: 90 min
measure: Heart rate
timeFrame: 90 min
measure: Power output during preload
timeFrame: 60 min
measure: Power output during time trial
timeFrame: 30 min
Other outcomes:
measure: Height
timeFrame: 1 min
measure: Weight
timeFrame: 1 min
measure: Age
timeFrame: 1 min
measure: Endurance training history
timeFrame: 1 min
measure: Plasma creatinine
timeFrame: 10 min
measure: Plasma alanine aminotransferase
timeFrame: 10 min
measure: Peak power of incremental test
timeFrame: 30 min
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
affiliation: Department of Nutrition, Exercise and Sports
name: Nikolai B Nordsborg, Dr
role: PRINCIPAL_INVESTIGATOR
References: