NCT01179802

Brief Summary

Until now it has been assumed that regular endurance training has a positive influence on cardiac function and that the positive effect increases with increasing intensity. However, little is known about the effects of intense endurance stress on the heart. According to current knowledge repeated exposure to strenuous endurance activity may lead to minor but possibly irreversible damage to the heart with resultant scarring of the heart's muscle. Within this study we attempt to find out by different analytical methods - in particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart muscle is affected by an intense endurance exercise, i.e. the "Jungfrau-Marathon", and which changes can possibly be found. Due to repeated measurements we will obtain further information on the short-term course of possible changes. Hypotheses: A single bout of prolonged strenuous exercise (PSE) leads to transient alteration in cardiac function accompanied by the appearance of biomarkers for myocardial damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

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

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

August 10, 2010

Last Update Submit

February 14, 2011

Conditions

Myocardial IschemiaExerciseMyocardial ContractionMyocardial StunningHeart Failure

Outcome Measures

Primary Outcomes (4)

  • Quantification of edema and/or ischemic areas with MRI

    baseline

  • Quantification of edema and/or ischemic areas with MRI

    24h post-marathon

  • Quantification of edema and/or ischemic areas with MRI

    5 days post-marathon

  • Quantification of edema and/or ischemic areas with MRI

    8 days post-marathon

Secondary Outcomes (15)

  • anthropometric data, VO2max, resting-ECG, stress-ECG, blood analyses

    at baseline

  • Cardiac contractility by echocardiography

    1h post-marathon

  • Cardiac contractility by echocardiography

    5 days post-marathon

  • Cardiac contractility by echocardiography

    8 days post-marathon

  • Cardiac contractility by echocardiography

    baseline

  • +10 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

single event of a prolonged strenuous endurance exercise (mountain marathon)

Other: Strenuous Endurance exercise

Interventions

Strenuous Endurance exerciseOTHER

"Jungfraumarathon": Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters.

1

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants of the Jungfraumarathon 2010
  • Elite runners defined by their results in the Jungfraumarathon 2009 (not more than 4:30 h, corresponding to a delay of 90 minutes compared to the winner)

You may not qualify if:

  • Contraindication for MRI
  • History of relevant cardiac disease (including cardiomyopathies)
  • coronary heart disease
  • coronary abnormalities
  • cardiovascular risk factors
  • History of any chronic disease
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • Wilhelm M, Zueger T, De Marchi S, Rimoldi SF, Brugger N, Steiner R, Stettler C, Nuoffer JM, Seiler C, Ith M. Inflammation and atrial remodeling after a mountain marathon. Scand J Med Sci Sports. 2014 Jun;24(3):519-25. doi: 10.1111/sms.12030. Epub 2012 Dec 18.

    PMID: 23253265DERIVED

MeSH Terms

Conditions

Myocardial IschemiaMotor ActivityMyocardial StunningHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Ith, PhD, PhD/MD

    Dept. of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

    PRINCIPAL INVESTIGATOR

  • Christoph Stettler, MD

    Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 11, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

CH(1)