Effect of Increased Pain Tolerance on Exercise Performance

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT03934411
Collaborator
Anti Doping Danmark (Other), Oslo University Hospital (Other)
16
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2
12.2
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Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2018
Actual Primary Completion Date :
Mar 7, 2019
Actual Study Completion Date :
Mar 7, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Power output [30 minutes]

    Mean power output during a 15-km time trial

  2. Motor-cognitive performance [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 [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 [90 min]

    The response of blood pH to exercise performance

  2. Lactate [90 min]

    The response of blood lactate to exercise performance

  3. Bicarbonate [90 min]

    The response of blood bicarbonate to exercise performance

  4. Glucose [90 min]

    The response of blood glucose to exercise performance

  5. Potassium [90 min]

    The response of blood potassium to exercise performance

  6. Sodium [90 min]

    The response of blood sodium to exercise performance

  7. Oxygen uptake [90 min]

    The response of systemic oxygen uptake during exercise performance

  8. Pulmonary ventilation [90 min]

    The response of pulmonary ventilation during exercise performance.

  9. Respiratory exchange ratio [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 [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 [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 [90 min]

    The response of heart rate to exercise performance

  13. Power output during preload [60 min]

    Mean power output during a 60-min cycling exercise

  14. Power output during time trial [30 min]

    The power output measured for each km of the time trial

Other Outcome Measures

  1. Height [1 min]

    Height of the subjects in cm

  2. Weight [1 min]

    Weight of the subjects in kg

  3. Age [1 min]

    Age of the subjects in years

  4. Endurance training history [1 min]

    Endurance training history of subjects in years

  5. Plasma creatinine [10 min]

    Concentration of plasma creatinine

  6. Plasma alanine aminotransferase [10 min]

    Concentration of plasma alanine aminotransferase

  7. Peak power of incremental test [30 min]

    The peak power of an incremental cycling test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nutrition, Exercise and Sports Copenhagen Denmark 2100

Sponsors and Collaborators

  • University of Copenhagen
  • Anti Doping Danmark
  • Oslo University Hospital

Investigators

  • Principal Investigator: Nikolai B Nordsborg, Dr, Department of Nutrition, Exercise and Sports

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nikolai Nordsborg, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT03934411
Other Study ID Numbers:
  • H-17028397
First Posted:
May 1, 2019
Last Update Posted:
May 1, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2019