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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01406730 |
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Date of registration:
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18/07/2011 |
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Primary sponsor: |
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Public title:
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Running Effect on Cardiovascular and Muscular Parameters
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Scientific title:
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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 |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01406730 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Michael Scharf, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Departement of Radiology, Division of Cardiology |
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Name:
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Michael Lell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Departement of Radiology, Division of Cardiology, University of Erlangen-Nurnberg |
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Name:
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Michael Uder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Departement of Radiology, University of Erlangen-Nurnberg |
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Name:
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Willi A Kalender, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Medical Physics, University of Erlangen, Germany |
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Name:
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Wolfgang Kemmler, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Medical Physics, University of Erlangen-Nurnberg, Germany |
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Name:
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Simon von Stengel, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Erlangen-Nürnberg Medical School |
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Key inclusion & exclusion criteria
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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)
Age minimum:
30 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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30-50 Years Old
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Healthy
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Males
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Untrained
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Intervention(s)
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Other: exercise
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Primary Outcome(s)
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myocardial mass/stroke volume
[Time Frame: 4 month]
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Secondary Outcome(s)
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Intima media thickness
[Time Frame: 4 month]
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maximal oxygen uptake
[Time Frame: 4 month]
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muscle strength/power
[Time Frame: 4 month]
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myocardial volume
[Time Frame: 4 month]
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Resting metabolic rate
[Time Frame: 4 month]
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Secondary ID(s)
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FAU-IMP-4463
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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