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Completed

NCT Number: NCT03934411

Effect of Increased Pain Tolerance on Exercise Performance

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.

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Key information

Conditions

Opioid Use Behavior Exercise Motor Activity

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

The subjects will orally ingest 100 mg tramadol retard actavis

Placebo

Other

The subjects will orally ingest 100 mg calcium powder

Primary outcomes

  1. Power output

    Time frame: 30 minutes

    Mean power output during a 15-km time trial

  2. Motor-cognitive performance

    Time frame: 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

  3. Detection rate

    Time frame: 1 day

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

Secondary outcomes

  1. pH

    Time frame: 90 min

    The response of blood pH to exercise performance

  2. Lactate

    Time frame: 90 min

    The response of blood lactate to exercise performance

  3. Bicarbonate

    Time frame: 90 min

    The response of blood bicarbonate to exercise performance

  4. Glucose

    Time frame: 90 min

    The response of blood glucose to exercise performance

  5. Potassium

    Time frame: 90 min

    The response of blood potassium to exercise performance

  6. Sodium

    Time frame: 90 min

    The response of blood sodium to exercise performance

  7. Oxygen uptake

    Time frame: 90 min

    The response of systemic oxygen uptake during exercise performance

  8. Pulmonary ventilation

    Time frame: 90 min

    The response of pulmonary ventilation during exercise performance.

  9. Respiratory exchange ratio

    Time frame: 90 min

    The 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.

  10. Rate of Perceived Exertion

    Time frame: 90 min

    Measurement 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.

  11. Leg Pain

    Time frame: 90 min

    Measurement 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.

  12. Heart rate

    Time frame: 90 min

    The response of heart rate to exercise performance

  13. Power output during preload

    Time frame: 60 min

    Mean power output during a 60-min cycling exercise

  14. Power output during time trial

    Time frame: 30 min

    The power output measured for each km of the time trial

Other outcomes

  1. Height

    Time frame: 1 min

    Height of the subjects in cm

  2. Weight

    Time frame: 1 min

    Weight of the subjects in kg

  3. Age

    Time frame: 1 min

    Age of the subjects in years

  4. Endurance training history

    Time frame: 1 min

    Endurance training history of subjects in years

  5. Plasma creatinine

    Time frame: 10 min

    Concentration of plasma creatinine

  6. Plasma alanine aminotransferase

    Time frame: 10 min

    Concentration of plasma alanine aminotransferase

  7. Peak power of incremental test

    Time frame: 30 min

    The peak power of an incremental cycling test

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Anti Doping Danmark
  • Oslo University Hospital

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 1, 2019
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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