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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Effect of Increased Pain Tolerance on Exercise Performance

Clinicaltrials.gov identifier NCT03934411

Recruitment Status Completed

First Posted May 1, 2019

Last update posted May 1, 2019

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:Opioid Use
    Exercise
  • Intervention/Treatment: Drug: Tramadol
    Other: Placebo
  • Phase: N/A
Detailed Description

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: March 2018
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 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 [ 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts
Locations

Denmark
Department of Nutrition, Exercise and Sports
Copenhagen

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

More Information
  • Responsible Party: University of Copenhagen
  • ClinicalTrials.gov Identifier: NCT03934411 History of Changes
  • Other Study ID Numbers: H-17028397
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No