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Ischemic Preconditioning in Endurance Athletes

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ClinicalTrials.gov Identifier: NCT01774461
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE January 24, 2013
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
Serum concentrations of cardiac troponins [ Time Frame: 6 hours, 2 hourly time intervals ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01774461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
Indices of cardiac function measured by echocardiography [ Time Frame: 2 hours post-exercise ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ischemic Preconditioning in Endurance Athletes
Official Title  ICMJE Influence of Remote Ischemic Preconditioning on Cardiac Function After Endurance Exercise
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Exercise
Intervention  ICMJE Other: Remote ischemic preconditioning
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.
Study Arms  ICMJE
  • 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.
  • 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.
    Intervention: Other: Remote ischemic preconditioning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2014)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2013)
35
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent
  • Healthy
  • Age between 18 and 65 years
  • Endurance-trained (two or more training sessions per week)

Exclusion Criteria:

  • Not applicable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774461
Other Study ID Numbers  ICMJE METC12-2-038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marja van Dieijen-Visser, PhD Department of Clinical Chemistry, MUMC, Maastricht, the Netherlands
PRS Account Maastricht University Medical Center
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP