The Effect of Remote Preconditioning on the Exercise Performance of the Elite Swimmers

August 14, 2013 updated by: Andrew Redington, The Hospital for Sick Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Swim Club, University of Toronto Athletic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Illness, surgery, or medical intervention within the last 48 hours
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Other: Real preconditioning followed by Sham preconditioning
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.
Experimental: 2
Other: Sham preconditioning followed by Real preconditioning
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in the peak velocity in the preconditioning subjects.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Breathing frequency.
Time Frame: 2 weeks
2 weeks
Blood lactate.
Time Frame: 2 weeks
2 weeks
Improvement in critical speed.
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Andrew Redington, MD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1000012617

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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