Effect of Increased Pain Tolerance on Exercise Performance

NCT ID: NCT03934411

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-07

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tramadol treatment

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

The subjects will orally ingest 100 mg tramadol retard actavis

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The subjects will orally ingest 100 mg calcium powder

Interventions

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Tramadol

The subjects will orally ingest 100 mg tramadol retard actavis

Intervention Type DRUG

Placebo

The subjects will orally ingest 100 mg calcium powder

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anti Doping Danmark

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Nikolai Nordsborg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolai B Nordsborg, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Exercise and Sports

Locations

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Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-17028397

Identifier Type: -

Identifier Source: org_study_id

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