Running Effect on Cardiovascular and Muscular Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Males; Untrained; 30-50 Years Old
• Intervention / Treatment: Other: exercise

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Institute of Medical Physics, University of Erlangen-Nurnberg
  • Erlangen, Germany, 91052
    • Institute of Physical Education and Sport Sciences
  • Erlangen, Germany, 91054
    • Departement of Radiology, University of Erlangen-Nurnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: exercise; 16 weeks of running exercise	Other: exercise; 16 week of periodized progressive running exercise 2-4 times/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myocardial mass/stroke volume	Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximal oxygen uptake	maximal oxygen uptake during running	4 month
Resting metabolic rate	Adaptation of resting metabolic rate to running exercise	4 month
muscle strength/power	Isometric muscle strength of the leg extensors Leg power as assessed by counter movement jump	4 month
myocardial volume	Functional and morphologic parameters of the heart as assessed by echocardiography	4 month
Intima media thickness	Carotid intima media thickness by high-resolution ultrasound	4 month

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: University of Erlangen-Nürnberg; Klinikum Nürnberg; Institute of Physical Education and Sports Sciences
• Investigators: Study Director: Michael Lell, MD, Departement of Radiology, Division of Cardiology, University of Erlangen-Nurnberg; Principal Investigator: Michael Scharf, MD, Departement of Radiology, Division of Cardiology; Study Chair: 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 Director: Wolfgang Kemmler, PhD, Institute of Medical Physics, University of Erlangen-Nurnberg, Germany; Principal Investigator: Simon von Stengel, PhD, University of Erlangen-Nürnberg Medical School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• homepage of the Institute of Medical Physical with study informations.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 11, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: blood; intervention; cardiac hypertrophy; maximum oxygen uptake; males; running exercise; untrained
• Other Study ID Numbers: FAU-IMP-4463