NCT00761566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

September 26, 2008

Last Update Submit

August 14, 2013

Conditions

Keywords

Elite swimmersExercisePreconditioning

Outcome Measures

Primary Outcomes (1)

  • Improvement in the peak velocity in the preconditioning subjects.

    2 weeks

Secondary Outcomes (3)

  • Breathing frequency.

    2 weeks

  • Blood lactate.

    2 weeks

  • Improvement in critical speed.

    2 weeks

Study Arms (2)

1

EXPERIMENTAL
Other: Real preconditioning followed by Sham preconditioning

2

EXPERIMENTAL
Other: Sham preconditioning followed by Real preconditioning

Interventions

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.

1

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.

2

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Swim Club, University of Toronto Athletic Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Andrew Redington, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Heart Centre-Cardiology Division

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 29, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations