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Effect of Increased Pain Tolerance on Exercise Performance

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ClinicalTrials.gov Identifier: NCT03934411
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Anti Doping Danmark
Oslo University Hospital
Information provided by (Responsible Party):
Nikolai Nordsborg, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Opioid Use Exercise Drug: Tramadol Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Increased Pain Tolerance on Exercise Performance
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : March 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: Tramadol treatment Drug: Tramadol
The subjects will orally ingest 100 mg tramadol retard actavis

Placebo Comparator: Placebo treatment Other: Placebo
The subjects will orally ingest 100 mg calcium powder




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934411


Locations
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Denmark
Department of Nutrition, Exercise and Sports
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Anti Doping Danmark
Oslo University Hospital
Investigators
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Principal Investigator: Nikolai B Nordsborg, Dr Department of Nutrition, Exercise and Sports
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Responsible Party: Nikolai Nordsborg, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03934411    
Other Study ID Numbers: H-17028397
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents