Clinical trial NCT01406730: Running Effect on Cardiovascular and Muscular Parameters
Official title: Effect of 16 Weeks of Running Exercise on Parameters Related to the Cardiovascular System, Blood and Muscle in Untrained Males 30-50 Years Old. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Males
Untrained
30-50 Years Old
Healthy
Keywords: running exercise
cardiac hypertrophy
blood
maximum oxygen uptake
intervention
untrained
males
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg
name: Institute of Physical Education and Sports Sciences
name: Klinikum Nürnberg
First posted: 2011-08-01
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* males
* untrained (\< 2 endurance exercise sessions/week)
* 30-50 years old

Exclusion Criteria:

* 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)

Primary outcomes:
measure: myocardial mass/stroke volume
timeFrame: 4 month
Secondary outcomes:
measure: maximal oxygen uptake
timeFrame: 4 month
measure: Resting metabolic rate
timeFrame: 4 month
measure: muscle strength/power
timeFrame: 4 month
measure: myocardial volume
timeFrame: 4 month
measure: Intima media thickness
timeFrame: 4 month
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nurnberg
city: Erlangen
country: Germany
facility: Institute of Physical Education and Sport Sciences
city: Erlangen
country: Germany
facility: Departement of Radiology, University of Erlangen-Nurnberg
Study officials:
affiliation: Departement of Radiology, Division of Cardiology, University of Erlangen-Nurnberg
name: Michael Lell, MD
role: STUDY_DIRECTOR
affiliation: Departement of Radiology, Division of Cardiology
name: Michael Scharf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Medical Physics, University of Erlangen, Germany
name: Willi A Kalender, PhD
role: STUDY_CHAIR
affiliation: Departement of Radiology, University of Erlangen-Nurnberg
name: Michael Uder, MD
role: STUDY_CHAIR
affiliation: Institute of Medical Physics, University of Erlangen-Nurnberg, Germany
name: Wolfgang Kemmler, PhD
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Simon von Stengel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.