Running Effect on Cardiovascular and Muscular Parameters

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406730
• Other study ID #: FAU-IMP-4463
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2011
• Last updated: August 11, 2012
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• 30-50 Years Old
• Healthy
• Males
• Untrained

Intervention

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

Locations

Country	Name	City	State
Germany	Departement of Radiology, University of Erlangen-Nurnberg	Erlangen
Germany	Institute of Medical Physics, University of Erlangen-Nurnberg	Erlangen
Germany	Institute of Physical Education and Sport Sciences	Erlangen

Sponsors (4)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Institute of Physical Education and Sports Sciences, Klinikum Nürnberg, University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial mass/stroke volume	Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)	4 month	No
Secondary	maximal oxygen uptake	maximal oxygen uptake during running	4 month	No
Secondary	Resting metabolic rate	Adaptation of resting metabolic rate to running exercise	4 month	No
Secondary	muscle strength/power	Isometric muscle strength of the leg extensors Leg power as assessed by counter movement jump	4 month	No
Secondary	myocardial volume	Functional and morphologic parameters of the heart as assessed by echocardiography	4 month	No
Secondary	Intima media thickness	Carotid intima media thickness by high-resolution ultrasound	4 month	No

External Links

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