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Optimization of Preventive Effects of Physical Training (SAusE)

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ClinicalTrials.gov Identifier: NCT01263522
Recruitment Status : Unknown
Verified December 2010 by Saarland University.
Recruitment status was:  Recruiting
First Posted : December 20, 2010
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
Saarland University

Brief Summary:

Health-promoting effects of physical exercise are well-investigated especially for endurance activities. However, for different individuals, positive effects have different sizes, even non-responders are observed. Other forms of training, such as strength training and interval training, are less well investigated. Therefore, a comparative longitudinal training study is warranted to examine differences of preventive effects (outcome measures: ergometric descriptors of physical performance, established risk factors and prognostic factors for cardiovascular diseases) of continuous endurance training, interval training and strength endurance training.

In a second stage, the observed non-responders will perform a different type of training (cross-over). It is expected, that besides a comparative general efficacy evaluation of the three training types, improved recommendations for optimized individualization of training parameters can be formulated.


Condition or disease Intervention/treatment
Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training Other: different training programs Other: control condition

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012

Arm Intervention/treatment
Experimental: Endurance training Other: different training programs
two different endurance programs and one strength endurance program
Experimental: interval training Other: different training programs
two different endurance programs and one strength endurance program
Experimental: strength endurance training Other: different training programs
two different endurance programs and one strength endurance program
Placebo Comparator: control Other: control condition
unchanged lifestyle



Primary Outcome Measures :
  1. VO2max [ Time Frame: 6 months ]
    determined during treadmill testing


Secondary Outcome Measures :
  1. resting heart rate [ Time Frame: 6 months ]
  2. resting blood pressure [ Time Frame: 6 months ]
  3. blood lipid profile [ Time Frame: 6 months ]
    ratio: total cholesterol/HDL-cholesterol



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: untrained, healthy and non-smoking men and women

Exclusion Criteria: Contraindications for physical activity, BMI > 30 kg/m2, resting blood pressure > 160/100 mmHg, diabetes, total cholesterol > 300 mg/dl, maximal oxygen uptake > 50 ml/min/kg for men and > 45 ml/min/kg for women, respectively. Other complaints or diseases that might interfere with exercise training


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263522


Locations
Germany
Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken Recruiting
Saarbrücken, Saarland, Germany, 66123
Contact: Tim Meyer, Prof. Dr. med.    (0)681 - 302 3750 ext +49    tim.meyer@mx.uni-saarland.de   
Sponsors and Collaborators
Saarland University