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Effect of Increased Pain Tolerance on Exercise Performance

Effect of Increased Pain Tolerance on Exercise Performance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03934411
Enrollment
16
Registered
2019-05-01
Start date
2018-03-01
Completion date
2019-03-07
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Opioid Use

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.

Interventions

DRUGTramadol

The subjects will orally ingest 100 mg tramadol retard actavis

OTHERPlacebo

The subjects will orally ingest 100 mg calcium powder

Sponsors

Anti Doping Danmark
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Power output30 minutesMean power output during a 15-km time trial
Detection rate1 dayThe detection rate of tramadol following the exercise intervention measured before, immediately after as well as 6 and 24h after treatment
Motor-cognitive performance1 hourThe motor-cognitive performance evaluated by mathematical calculations combined with the ability to pinch a certain force with the thumb and index finger

Secondary

MeasureTime frameDescription
Sodium90 minThe response of blood sodium to exercise performance
Pulmonary ventilation90 minThe response of pulmonary ventilation during exercise performance.
Respiratory exchange ratio90 minThe response of respiratory exchange ratio during exercise performance, calculated as the ratio between system oxygen uptake and systemic carbon monoxide production. The unit of measure is arbitrary.
Rate of Perceived Exertion90 minMeasurement of the rate of perceived exertion by questionnaire during exercise performance using The borg scale of perceived exertion, which range from 6 (minimum value) to 20 (maximum value). Higher values represent a higher perceived exertion.
Leg Pain90 minMeasurement of the leg pain by questionnaire during exercise performance using the 10-point pain scale, which range from 0 (minimum) to 10 (maximum). Higher values represent a higher pain.
Heart rate90 minThe response of heart rate to exercise performance
Power output during preload60 minMean power output during a 60-min cycling exercise
Power output during time trial30 minThe power output measured for each km of the time trial
pH90 minThe response of blood pH to exercise performance
Lactate90 minThe response of blood lactate to exercise performance
Bicarbonate90 minThe response of blood bicarbonate to exercise performance
Glucose90 minThe response of blood glucose to exercise performance
Potassium90 minThe response of blood potassium to exercise performance
Oxygen uptake90 minThe response of systemic oxygen uptake during exercise performance

Other

MeasureTime frameDescription
Plasma creatinine10 minConcentration of plasma creatinine
Plasma alanine aminotransferase10 minConcentration of plasma alanine aminotransferase
Peak power of incremental test30 minThe peak power of an incremental cycling test
Endurance training history1 minEndurance training history of subjects in years
Height1 minHeight of the subjects in cm
Age1 minAge of the subjects in years
Weight1 minWeight of the subjects in kg

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026