Running Effect on Cardiovascular and Muscular Parameters

Phase 3

Completed

• Conditions: Males; Untrained; 30-50 Years Old; Healthy
• Interventions: Other: exercise

• Registration Number: NCT01406730
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-11
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
exercise	exercise	16 weeks of running exercise

Primary Outcome Measures

Name	Time	Method
myocardial mass/stroke volume	4 month	Atrial and ventricular volume and mass indexes were assessed by magnetic resonance imaging (MRI)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Institute of Medical Physics, University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Germany

Institute of Physical Education and Sport Sciences; 🇩🇪 Erlangen, Germany

Departement of Radiology, University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Germany