Effect of Increased Pain Tolerance on Exercise Performance

Exercise Clinical Trial

Official title:

Effect of Increased Pain Tolerance on Exercise Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934411
• Other study ID #: H-17028397
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 7, 2019

Study information

• Verified date: April 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Opioid Use

Intervention

Drug:
• Tramadol
The subjects will orally ingest 100 mg tramadol retard actavis

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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Anti Doping Danmark, Oslo University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height	Height of the subjects in cm	1 min
Other	Weight	Weight of the subjects in kg	1 min
Other	Age	Age of the subjects in years	1 min
Other	Endurance training history	Endurance training history of subjects in years	1 min
Other	Plasma creatinine	Concentration of plasma creatinine	10 min
Other	Plasma alanine aminotransferase	Concentration of plasma alanine aminotransferase	10 min
Other	Peak power of incremental test	The peak power of an incremental cycling test	30 min
Primary	Power output	Mean power output during a 15-km time trial	30 minutes
Primary	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
Primary	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	pH	The response of blood pH to exercise performance	90 min
Secondary	Lactate	The response of blood lactate to exercise performance	90 min
Secondary	Bicarbonate	The response of blood bicarbonate to exercise performance	90 min
Secondary	Glucose	The response of blood glucose to exercise performance	90 min
Secondary	Potassium	The response of blood potassium to exercise performance	90 min
Secondary	Sodium	The response of blood sodium to exercise performance	90 min
Secondary	Oxygen uptake	The response of systemic oxygen uptake during exercise performance	90 min
Secondary	Pulmonary ventilation	The response of pulmonary ventilation during exercise performance.	90 min
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart rate	The response of heart rate to exercise performance	90 min
Secondary	Power output during preload	Mean power output during a 60-min cycling exercise	60 min
Secondary	Power output during time trial	The power output measured for each km of the time trial	30 min