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Optimization of Preventive Effects of Physical Training (SAusE)

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ClinicalTrials.gov Identifier: NCT01263522
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Saarland University

December 17, 2010
December 20, 2010
May 10, 2018
December 2010
December 2013   (Final data collection date for primary outcome measure)
VO2 max [ Time Frame: 6 months ]
determined during treadmill testing
Same as current
Complete list of historical versions of study NCT01263522 on ClinicalTrials.gov Archive Site
  • resting heart rate [ Time Frame: 6 months ]
  • resting blood pressure [ Time Frame: 6 months ]
  • blood lipid profile [ Time Frame: 6 months ]
    ratio: total cholesterol/HDL-cholesterol
Same as current
Not Provided
Not Provided
 
Optimization of Preventive Effects of Physical Training
Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training
  • Other: different training programs
    two different endurance programs and one strength endurance program
  • Other: control condition
    unchanged lifestyle
  • Experimental: Endurance training
    Intervention: Other: different training programs
  • Experimental: interval training
    Intervention: Other: different training programs
  • Experimental: strength endurance training
    Intervention: Other: different training programs
  • Placebo Comparator: control
    Intervention: Other: control condition

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
200
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • untrained
  • healthy
  • non-smoking

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
Sexes Eligible for Study: All
30 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01263522
SAusE2011
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Saarland University
Saarland University
Not Provided
Not Provided
Saarland University
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP