Ergogenic Athletic PerformanceNCT02255630
Anaerobic Power and Salbutamol
A study testing Cycling Exercise in people with Ergogenic Athletic Performance, run by University of British Columbia at 1 site in Canada.
Trial summary
Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ergogenic Athletic Performance
- What is being tested?
- Cycling Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1 for men and women
Who cannot join
- pregnant women
- any history of uncontrolled respiratory or cardiac disease
- smokers
- diabetics
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Environmental Physiology Laboratory
Vancouver, British Columbia, V6T 1Z1
About this study
Official title: The Effects of High-dose Salbutamol on Anaerobic Cycling Power
Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Although the majority of these studies do not show an ergogenic effect, the small number of studies with extended exercise bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have different effects on these two groups of athletes, the investigators will measure exercise performance in both female and male elite cyclists. The investigators hypothesize that athletes will perform better during a combination steady-state/sprint exercise task following salbutamol administration.
- Conditions
- Ergogenic Athletic Performance
- Being tested
- Cycling Exercise
- Keywords
- salbutamol, exercise-induced bronchoconstriction, anaerobic power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol inhalation | Experimental | Study participants will be exposed to 1600ug salbutamol 30min prior to exercise Receives: Other: Cycling Exercise |
| Placebo inhalation | Experimental | Study participants will be exposed to 1600ug salbutamol 30min prior to exercise Receives: Other: Cycling Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Power Output
Measured: peak power output of the final 30 seconds of the cycling bout will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ergogenic Athletic PerformanceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
- Investigators
- Michael S Koehle, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255630
- Sponsor's protocol ID
- H14-02788
- Status last verified
- Nov 2016
- First submitted
- 16 Sep 2014
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-dose Salbutamol on Anaerobic Cycling Power
- ClinicalTrials.gov ID
- NCT02255630
- Acronym / sponsor ID
- H14-02788
- Conditions
- Ergogenic Athletic Performance
- Keywords
- salbutamol, exercise-induced bronchoconstriction, anaerobic power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Although the majority of these studies do not show an ergogenic effect, the small number of studies with extended exercise bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have different effects on these two groups of athletes, the investigators will measure exercise performance in both female and male elite cyclists. The investigators hypothesize that athletes will perform better during a combination steady-state/sprint exercise task following salbutamol administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol inhalation | Experimental | Other: Cycling ExerciseStudy participants will be exposed to 1600ug salbutamol 30min prior to exercise |
| Placebo inhalation | Experimental | Other: Cycling ExerciseStudy participants will be exposed to 1600ug salbutamol 30min prior to exercise |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1 for men and women
Key exclusion criteria (4 listed)
- pregnant women
- any history of uncontrolled respiratory or cardiac disease
- smokers
- diabetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling Exercise | Other | Placebo inhalation, Salbutamol inhalation |
Primary outcome
Peak Power Output
Time frame: peak power output of the final 30 seconds of the cycling bout will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Koehle, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling Exercise in people with Ergogenic Athletic Performance, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Power Output (time frame: peak power output of the final 30 seconds of the cycling bout will be assessed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.