NCT01774461

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

July 9, 2012

Last Update Submit

March 18, 2014

Conditions

Exercise

Outcome Measures

Primary Outcomes (1)

  • Serum concentrations of cardiac troponins

    6 hours, 2 hourly time intervals

Secondary Outcomes (1)

  • Indices of cardiac function measured by echocardiography

    2 hours post-exercise

Study Arms (2)

Sham RIC

NO INTERVENTION

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.

Remote ischemic conditioning

ACTIVE COMPARATOR

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.

Other: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioningOTHER

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.

Remote ischemic conditioning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marja van Dieijen-Visser, PhD

    Department of Clinical Chemistry, MUMC, Maastricht, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

January 24, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

NL(1)