- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774461
Ischemic Preconditioning in Endurance Athletes
March 18, 2014 updated by: Maastricht University Medical Center
Influence of Remote Ischemic Preconditioning on Cardiac Function After Endurance Exercise
The aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
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
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Maastricht, Netherlands
- Maastricht University Medical Center
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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
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent
- Healthy
- Age between 18 and 65 years
- Endurance-trained (two or more training sessions per week)
Exclusion Criteria:
- Not applicable
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
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: Sham RIC
Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm.
The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated.
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ACTIVE_COMPARATOR: Remote ischemic conditioning
Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
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Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Serum concentrations of cardiac troponins
Time Frame: 6 hours, 2 hourly time intervals
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6 hours, 2 hourly time intervals
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Indices of cardiac function measured by echocardiography
Time Frame: 2 hours post-exercise
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2 hours post-exercise
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marja van Dieijen-Visser, PhD, Department of Clinical Chemistry, MUMC, Maastricht, the Netherlands
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
March 1, 2013
Primary Completion (ACTUAL)
September 1, 2013
Study Completion (ACTUAL)
September 1, 2013
Study Registration Dates
First Submitted
July 9, 2012
First Submitted That Met QC Criteria
January 21, 2013
First Posted (ESTIMATE)
January 24, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 19, 2014
Last Update Submitted That Met QC Criteria
March 18, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- METC12-2-038
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.