Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Running Effect on Cardiovascular and Muscular Parameters

This study has been completed.
Sponsor:
Collaborators:
University of Erlangen-Nürnberg
Institute of Physical Education and Sports Sciences
Klinikum Nürnberg
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01406730
First received: July 18, 2011
Last updated: August 11, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Males
Untrained
30-50 Years Old
Healthy
Other: exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • myocardial mass/stroke volume [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)


Secondary Outcome Measures:
  • maximal oxygen uptake [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    maximal oxygen uptake during running

  • Resting metabolic rate [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Adaptation of resting metabolic rate to running exercise

  • muscle strength/power [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Isometric muscle strength of the leg extensors Leg power as assessed by counter movement jump

  • myocardial volume [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Functional and morphologic parameters of the heart as assessed by echocardiography

  • Intima media thickness [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Carotid intima media thickness by high-resolution ultrasound


Enrollment: 80
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
16 weeks of running exercise
Other: exercise
16 week of periodized progressive running exercise 2-4 times/week
No Intervention: control

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406730

Locations
Germany
Departement of Radiology, University of Erlangen-Nurnberg
Erlangen, Germany, 91054
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Germany, 91052
Institute of Physical Education and Sport Sciences
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg
Institute of Physical Education and Sports Sciences
Klinikum Nürnberg
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
  More Information

Additional Information:
Publications:
Responsible Party: Wolfgang Kemmler, Prof. Dr., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01406730     History of Changes
Other Study ID Numbers: FAU-IMP-4463
Study First Received: July 18, 2011
Last Updated: August 11, 2012
Health Authority: Germany: Ethics Commission
Germany: Federal Ministry of Education and Research

Keywords provided by University of Erlangen-Nürnberg Medical School:
running exercise
cardiac hypertrophy
blood
maximum oxygen uptake
intervention
untrained
males

ClinicalTrials.gov processed this record on November 25, 2014