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.

Study Overview

• Status: Completed
• Conditions: Exercise; Opioid Use
• Intervention / Treatment: Drug: Tramadol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo treatment	Other: Placebo; The subjects will orally ingest 100 mg calcium powder
Experimental: Tramadol treatment	Drug: Tramadol; The subjects will orally ingest 100 mg tramadol retard actavis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power output	Mean power output during a 15-km time trial	30 minutes
Motor-cognitive performance	The motor-cognitive performance evaluated by mathematical calculations combined with the ability to pinch a certain force with the thumb and index finger	1 hour
Detection rate	The detection rate of tramadol following the exercise intervention measured before, immediately after as well as 6 and 24h after treatment	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH	The response of blood pH to exercise performance	90 min
Lactate	The response of blood lactate to exercise performance	90 min
Bicarbonate	The response of blood bicarbonate to exercise performance	90 min
Glucose	The response of blood glucose to exercise performance	90 min
Potassium	The response of blood potassium to exercise performance	90 min
Sodium	The response of blood sodium to exercise performance	90 min
Oxygen uptake	The response of systemic oxygen uptake during exercise performance	90 min
Pulmonary ventilation	The response of pulmonary ventilation during exercise performance.	90 min
Respiratory exchange ratio	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.	90 min
Rate of Perceived Exertion	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.	90 min
Leg Pain	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.	90 min
Heart rate	The response of heart rate to exercise performance	90 min
Power output during preload	Mean power output during a 60-min cycling exercise	60 min
Power output during time trial	The power output measured for each km of the time trial	30 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height of the subjects in cm	1 min
Weight	Weight of the subjects in kg	1 min
Age	Age of the subjects in years	1 min
Endurance training history	Endurance training history of subjects in years	1 min
Plasma creatinine	Concentration of plasma creatinine	10 min
Plasma alanine aminotransferase	Concentration of plasma alanine aminotransferase	10 min
Peak power of incremental test	The peak power of an incremental cycling test	30 min

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Oslo University Hospital; Anti Doping Danmark
• Investigators: Principal Investigator: Nikolai B Nordsborg, Dr, Department of Nutrition, Exercise and Sports

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): March 7, 2019

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: H-17028397

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No