HealthyPhase 2NCT00761566
The Effect of Remote Preconditioning on the Exercise Performance of the Elite Swimmers
A Phase 2 study of Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
In this study, we will test the hypothesis that preconditioning highly trained swimmers using skeletal muscle ischemia as the stimulus will improve exercise performance assessment. Read more about this study
- Who is it for?
- Ages 13 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Feb 2010
- Phase
- Phase 2
- 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 13 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy male or female athlete volunteers
- Post-pubescent swimmers between the ages of 13 and 22 years (or healthy non-athletes (for the "equipment control" group and for the control arm for the animal model section)
- Members of competitive swimming teams
- Have achieved a swimming performance time within 5% of national qualification standards
Who cannot join
- Illness, surgery, or medical intervention within the last 48 hours
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Swim Club, University of Toronto Athletic Centre
Toronto, Ontario
About this study
Official title: Double Blind Randomized Controlled Trial of the Effect of Remote Preconditioning on the Exercise Performance of the Elite Swimmers
In this study, we will test the hypothesis that preconditioning highly trained swimmers using skeletal muscle ischemia as the stimulus will improve exercise performance assessment.
Read the detailed description
The main purpose of this study is to determine if it is possible to precondition competitive swimmers and improve their exercise performance to provide further insight into the physiological mechanisms through which preconditioning may function. With four 5 minute inflation cycles of a blood-pressure cuff, we will induce skeletal muscle ischemia which is known to be a powerful method of preconditioning. Each swimmer will be blinded to the expected effect and randomly assigned to real preconditioning versus the sham intervention which will consist of four 5 minute cycles of blood pressure cuff inflation to 10mmHg. During a subsequent training session, the subjects will receive the intervention they have not received during the previous test session. Therefore, each subject will be part of both study groups and will serve as their own control. To evaluate the exercise performance, the subjects will perform an incremental swimming test protocol based on methods developed and reported by a member our research team. Swimming velocity, blood lactate level, heart rate, breathing frequency, dyspnoea and oxygen saturation will be measured during incremental exercise. Finally, we would like to determine the preconditioning effect of regular exercise training in an animal model.
Exercise performance is thought to be limited by skeletal, cardiac and respiratory muscle fatigue associated with episodes of exercise induced arterial hypoxemia. Preconditioning is defined as a period of brief lack of oxygen or ischemia in a tissue that protects the heart or any other organ from another sustained episode of ischemia. Preconditioning is believed to improve exercise performance by protecting the skeletal, cardiac and respiratory muscles against decreased oxygen and by-products of anaerobic metabolism that may limit an individual's exercise performance. Elite athletes, such as highly trained swimmers, may provide the research team with the opportunity to evaluate the effect of preconditioning during local tissue hypoxia and anaerobic metabolic by-products in healthy adolescents, which is otherwise not possible. With this study, we will show if it is possible to precondition competitive swimmers and improve their exercise performance using ischemia of the limb as a preconditioning stimulus.
- Conditions
- Healthy
- Being tested
- Real preconditioning followed by Sham preconditioning, Sham preconditioning followed by Real preconditioning
- Keywords
- Elite swimmers, Exercise, Preconditioning
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real preconditioning followed by Sham preconditioningOther
Subjects in this arm of the study will first receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a blood-pressure cuff inflated to a pressure of 15 mmHg greater than systolic arterial pressure. The subjects will then cross-over to the other arm of the study and receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a sham procedure consisting of inflating the blood pressure cuff to 10 mmHg.
Sham preconditioning followed by Real preconditioningOther
Subjects in this arm of the study will first receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a sham procedure consisting of inflating the blood pressure cuff to 10 mmHg. They will then cross-over to the other arm of the study and receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a blood-pressure cuff inflated to a pressure of 15 mmHg greater than systolic arterial pressure.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Real preconditioning followed by Sham preconditioning |
| 2 | Experimental | Not described Receives: Other: Sham preconditioning followed by Real preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the peak velocity in the preconditioning subjects.
Measured: 2 weeks
Secondary outcomes (3)
Breathing frequency.
Measured: 2 weeks
Blood lactate.
Measured: 2 weeks
Improvement in critical speed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Redington, The Hospital for Sick Children
- Investigators
- Andrew Redington, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761566
- Sponsor's protocol ID
- 1000012617
- Status last verified
- Aug 2013
- First submitted
- 26 Sep 2008
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Trial of the Effect of Remote Preconditioning on the Exercise Performance of the Elite Swimmers
- ClinicalTrials.gov ID
- NCT00761566
- Acronym / sponsor ID
- 1000012617
- Conditions
- Healthy
- Keywords
- Elite swimmers, Exercise, Preconditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Sep 2008 (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.
In this study, we will test the hypothesis that preconditioning highly trained swimmers using skeletal muscle ischemia as the stimulus will improve exercise performance assessment.
Detailed description
The main purpose of this study is to determine if it is possible to precondition competitive swimmers and improve their exercise performance to provide further insight into the physiological mechanisms through which preconditioning may function. With four 5 minute inflation cycles of a blood-pressure cuff, we will induce skeletal muscle ischemia which is known to be a powerful method of preconditioning. Each swimmer will be blinded to the expected effect and randomly assigned to real preconditioning versus the sham intervention which will consist of four 5 minute cycles of blood pressure cuff inflation to 10mmHg. During a subsequent training session, the subjects will receive the intervention they have not received during the previous test session. Therefore, each subject will be part of both study groups and will serve as their own control. To evaluate the exercise performance, the subjects will perform an incremental swimming test protocol based on methods developed and reported by a member our research team. Swimming velocity, blood lactate level, heart rate, breathing frequency, dyspnoea and oxygen saturation will be measured during incremental exercise. Finally, we would like to determine the preconditioning effect of regular exercise training in an animal model.
Exercise performance is thought to be limited by skeletal, cardiac and respiratory muscle fatigue associated with episodes of exercise induced arterial hypoxemia. Preconditioning is defined as a period of brief lack of oxygen or ischemia in a tissue that protects the heart or any other organ from another sustained episode of ischemia. Preconditioning is believed to improve exercise performance by protecting the skeletal, cardiac and respiratory muscles against decreased oxygen and by-products of anaerobic metabolism that may limit an individual's exercise performance. Elite athletes, such as highly trained swimmers, may provide the research team with the opportunity to evaluate the effect of preconditioning during local tissue hypoxia and anaerobic metabolic by-products in healthy adolescents, which is otherwise not possible. With this study, we will show if it is possible to precondition competitive swimmers and improve their exercise performance using ischemia of the limb as a preconditioning stimulus.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Real preconditioning followed by Sham preconditioning |
| 2 | Experimental | Other: Sham preconditioning followed by Real preconditioning |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy male or female athlete volunteers
- Post-pubescent swimmers between the ages of 13 and 22 years (or healthy non-athletes (for the "equipment control" group and for the control arm for the animal model section)
- Members of competitive swimming teams
- Have achieved a swimming performance time within 5% of national qualification standards
Key exclusion criteria (2 listed)
- Illness, surgery, or medical intervention within the last 48 hours
- Diabetes mellitus
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 |
|---|---|---|
| Real preconditioning followed by Sham preconditioningSubjects in this arm of the study will first receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a blood-pressure cuff inflated to a pressure of 15 mmHg greater than systolic arterial pressure. The subjects will then cross-over to the other arm of the study and receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a sham procedure consisting of inflating the blood pressure cuff to 10 mmHg. | Other | 1 |
| Sham preconditioning followed by Real preconditioningSubjects in this arm of the study will first receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a sham procedure consisting of inflating the blood pressure cuff to 10 mmHg. They will then cross-over to the other arm of the study and receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a blood-pressure cuff inflated to a pressure of 15 mmHg greater than systolic arterial pressure. | Other | 2 |
Primary outcome
Improvement in the peak velocity in the preconditioning subjects.
Time frame: 2 weeks
3 secondary outcomes
Breathing frequency.
Time frame: 2 weeks
Blood lactate.
Time frame: 2 weeks
Improvement in critical speed.
Time frame: 2 weeks
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 15 Aug 2013.
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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.
Andrew Redington, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Healthy, run by The Hospital for Sick Children 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 4 inclusion and 2 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 15 Aug 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in the peak velocity in the preconditioning subjects. (time frame: 2 weeks). 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 15 Aug 2013.