Effect of Increased Pain Tolerance on Exercise Performance

NCT03934411 | Completed

• 1 other identifier: H-17028397
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• pH

  90 min

• Lactate

  90 min

• Bicarbonate

  90 min

• Glucose

  90 min

• Potassium

  90 min

Other Outcomes (7)

• Height

  1 min

• Weight

  1 min

• Age

  1 min

Study Arms (2)

Tramadol treatment

EXPERIMENTAL

Drug: Tramadol

Placebo treatment

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tramadol DRUG

The subjects will orally ingest 100 mg tramadol retard actavis

Tramadol treatment

Placebo OTHER

The subjects will orally ingest 100 mg calcium powder

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Donated blood within the last 3 months
• Exposed to an altitude greater than 1000 m above sea level within the last two months
• Smoking

Sponsors & Collaborators

• University of Copenhagen: lead
• Anti Doping Danmark: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Nikolai B Nordsborg, Dr

  Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 1, 2019
• Study Start: March 1, 2018
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

DK (1)