NCT01406730

Brief Summary

The purpose of the study is to determine the effect of 16 weeks of running exercise on various parameters related to heart, vascular systems, blood, and muscle in untrained males 30-50 years old. Further, the investigators assess which of the above mentioned parameters may explain the increase of running performance most accurate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

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, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

July 18, 2011

Last Update Submit

August 11, 2012

Conditions

MalesUntrained30-50 Years OldHealthy

Keywords

running exercisecardiac hypertrophybloodmaximum oxygen uptakeinterventionuntrainedmales

Outcome Measures

Primary Outcomes (1)

  • myocardial mass/stroke volume

    Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)

    4 month

Secondary Outcomes (5)

  • maximal oxygen uptake

    4 month

  • Resting metabolic rate

    4 month

  • muscle strength/power

    4 month

  • myocardial volume

    4 month

  • Intima media thickness

    4 month

Study Arms (2)

exercise

EXPERIMENTAL

16 weeks of running exercise

Other: exercise

control

NO INTERVENTION

Interventions

exerciseOTHER

16 week of periodized progressive running exercise 2-4 times/week

exercise

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males
  • untrained (\< 2 endurance exercise sessions/week)
  • years old

You may not qualify if:

  • pathological changes of the heart
  • inflammable diseases
  • medication/diseases affecting cardiovascular system and muscle
  • very low physical capacity (\< 100 Watt at ergometry)
  • obesity (BMI \> 30 kg/m2)
  • more than 2 weeks of absence during the interventional period
  • more than 2 exercise session beside the intervention
  • contraindication related to MRI-assessment (i.e. claustrophobia, magnetizable intracorporal artefacts)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

Institute of Physical Education and Sport Sciences

Erlangen, 91052, Germany

Location

Departement of Radiology, University of Erlangen-Nurnberg

Erlangen, 91054, Germany

Location

Related Publications (3)

  • Scharf M, Brem MH, Wilhelm M, Schoepf UJ, Uder M, Lell MM. Atrial and ventricular functional and structural adaptations of the heart in elite triathletes assessed with cardiac MR imaging. Radiology. 2010 Oct;257(1):71-9. doi: 10.1148/radiol.10092377. Epub 2010 Aug 31.

    PMID: 20807850BACKGROUND

  • Tuttor M, von Stengel S, Kohl M, Lell M, Scharf M, Uder M, Wittke A, Kemmler W. High Intensity Resistance Exercise Training vs. High Intensity (Endurance) Interval Training to Fight Cardiometabolic Risk Factors in Overweight Men 30-50 Years Old. Front Sports Act Living. 2020 Jun 16;2:68. doi: 10.3389/fspor.2020.00068. eCollection 2020.

    PMID: 33345059DERIVED

  • Scharf M, Schmid A, Kemmler W, von Stengel S, May MS, Wuest W, Achenbach S, Uder M, Lell MM. Myocardial adaptation to high-intensity (interval) training in previously untrained men with a longitudinal cardiovascular magnetic resonance imaging study (Running Study and Heart Trial). Circ Cardiovasc Imaging. 2015 Apr;8(4):e002566. doi: 10.1161/CIRCIMAGING.114.002566.

    PMID: 25873721DERIVED

Related Links

MeSH Terms

Conditions

Cardiomegaly

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael Lell, MD

    Departement of Radiology, Division of Cardiology, University of Erlangen-Nurnberg

    STUDY DIRECTOR

  • Michael Scharf, MD

    Departement of Radiology, Division of Cardiology

    PRINCIPAL INVESTIGATOR

  • Willi A Kalender, PhD

    Institute of Medical Physics, University of Erlangen, Germany

    STUDY CHAIR

  • Michael Uder, MD

    Departement of Radiology, University of Erlangen-Nurnberg

    STUDY CHAIR

  • Wolfgang Kemmler, PhD

    Institute of Medical Physics, University of Erlangen-Nurnberg, Germany

    STUDY DIRECTOR

  • Simon von Stengel, PhD

    University of Erlangen-Nürnberg Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 18, 2011

First Posted

August 1, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

DE(3)